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Evaluating adherence, tolerability and safety of oral calcium citrate in elderly osteopenic subjects: a real-life non-interventional, prospective, multicenter study.
Rondanelli, M, Minisola, S, Barale, M, Barbaro, D, Mansueto, F, Battaglia, S, Bonaccorsi, G, Caliri, S, Cavioni, A, Colangelo, L, et al
Aging clinical and experimental research. 2024;36(1):38
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The occurrence of fractures and osteoporosis are significant concerns in elderly adults, as ageing remains one of the primary risk factors for these conditions. While the incidence of fracture and risk may vary, the incidence of fragility fractures significantly increases with advancing age, particularly after the age of 50 years. This study's aim was to evaluate the adherence, tolerability, and safety of calcium citrate administration in an "outpatient" population in routine clinical practice. This study was a non-interventional, prospective, multicentre study. Two-hundred and sixty-eight individuals (comprised 245 females (91.4%) and 23 males (8.6%)) were enrolled. Results showed a high rate of adherence to calcium citrate supplementation over a one-year period in osteopenic elderly subjects. Additionally, the incidence of adverse reactions was low (3.9%), further emphasizing the tolerability of calcium citrate. Authors concluded that future studies designed to assess the long-term impact of calcium citrate supplementation on hard endpoints, such as bone density, fractures/falls, quality of life measures and adherence are needed.
Expert Review
Conflicts of interest:
None
Take Home Message:
- The occurrence of fractures and osteoporosis are significant concerns in older adults, as ageing remains one of the primary risk factors for this condition.
- Calcium supplementation, usually with vitamin D, is a recommended complement to other specific pharmacological treatments of osteoporosis.
- This non-interventional, prospective multicentre study suggests a 91% adherence to calcium citrate supplementation over one year in elderly osteopenic patients with generally good (80%) tolerability and 4% reporting gastrointestinal adverse effects.
Evidence Category:
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A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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B: Systematic reviews including RCTs of limited number
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C: Non-randomized trials, observational studies, narrative reviews
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D: Case-reports, evidence-based clinical findings
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E: Opinion piece, other
Summary Review:
Introduction
A non-interventional, prospective multicentre study was conducted to evaluate the adherence, safety, and tolerability of calcium citrate supplementation in elderly osteopenic subjects.
Method:
A total of 231 Caucasian female (91%) and male (8%) participants with a median age of 70 received 500mg of calcium citrate supplementation daily for one year. Adherence was assessed based on tolerability, compliance, and persistence. Safety evaluations included monitoring of adverse reactions (ARs), physical examinations, and clinical laboratory evaluations.
Results
A total of 222 out of 231 participants (96%) completed the study. Nine subjects did not return for assessments or complete their diaries.
The primary and secondary findings of this study were as follows:
- An average adherence of 91% of oral calcium citrate supplementation was observed which was higher than the reported reference rate of 57% (p = 0.0179).
- Subjects with adherence <80% experienced a higher frequency of adverse events compared to those with adherence >80% (32/77; 42% vs 16/145%, (p = 0.0001).
- Gastrointestinal ARs were the most commonly reported, with constipation comprising 50% of all reported ARs.
- Reductions in systolic (130.7 ± 16.9 mmHg to 127.9 ± 14.5 mmHg) (p = 0.0102) and diastolic blood pressure 79.5 ± 8.7 mmHg to 77.4 ± 8.6 mmHg (baseline to V2) (p = 0.0116) were observed from baseline to the second visit.
- Positive changes were also noted in nutritional status (p = 0.0116), circulatory system disorders (p = 0.0001), and muscles/skeleton disorders (p = 0.0067) from baseline to post-baseline visit.
Conclusion:
This study revealed a 91% adherence to calcium citrate supplementation over one year in older adults with osteopenia, Additionally, the 4% incidents of ARs reported were related to gastrointestinal disorders.
Clinical practice applications:
- The prevalence of osteoporosis rises as individuals age, with approximately 10% of women at 60 years, 20% at 70 years, and 40% at 80 years.
- Calcium supplementation, usually with vitamin D, is a recommended complement to other specific pharmacological treatments of osteoporosis.
- The safety of calcium supplements remains controversial regarding an increased risk of cardiovascular events. Therefore, it is essential to investigate the safety profile of calcium in these populations.
- This study reported adherence, tolerability, and safety of calcium citrate supplementation in osteopenic elderly patients with 4% of patients reporting gastrointestinal adverse effects.
Considerations for future research:
- This study was conducted on 91% Caucasian females and 8% males with a mean age of 70 years therefore, there is a need to include more male and Asian participants from various age groups in further research.
- Future studies are needed to assess the long-term impact of calcium citrate supplementation on bone density, fractures, and quality of life.
Abstract
BACKGROUND Osteoporosis is a common concern in the elderly that leads to fragile bones. Calcium supplementation plays a crucial role in improving bone health, reducing fracture risk, and supporting overall skeletal strength in this vulnerable population. However, there is conflicting evidence on the safety of calcium supplements in elderly individuals. AIM: The aim of this study was to evaluate the adherence, safety and tolerability of calcium citrate supplementation in elderly osteopenic subjects. METHODS In this non-interventional, prospective, multicenter study, subjects received daily 500 mg calcium citrate supplementation for up to one year. Adherence was calculated based on compliance and persistence. Safety was assessed through adverse reactions (ARs), deaths, and clinical laboratory evaluations. RESULTS A total of 268 Caucasian subjects (91.4% female, mean age 70 ± 4.5 years) participated in the study. Mean adherence to treatment was 76.6 ± 29.5% and half of subjects had an adherence of 91% and ~ 33% of participants achieved complete (100%) adherence. ARs were reported by nine (3.9%) subjects, primarily gastrointestinal disorders, with no serious ARs. The frequency of all adverse events (including ARs) was significantly higher in subjects with adherence of < 80% (41.6%; 32/77) vs. those with adherence ≥ 80% (11%; 16/145, p < 0.0001). Both systolic and diastolic blood pressure decreased from baseline to follow-up visit (change of -2.8 ± 13.9 mmHg, p = 0.0102 and -2.1 ± 10.4 mmHg, p = 0.0116, respectively). CONCLUSION This study demonstrated favorable adherence to calcium citrate supplementation in elderly osteopenic subjects. The occurrence of ARs, though generally mild, were associated with lower adherence to calcium supplementation.
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Impact of a specialized oral nutritional supplement on quality of life in older adults following hospitalization: Post-hoc analysis of the NOURISH trial.
Baggs, GE, Middleton, C, Nelson, JL, Pereira, SL, Hegazi, RM, Matarese, L, Matheson, E, Ziegler, TR, Tappenden, KA, Deutz, N
Clinical nutrition (Edinburgh, Scotland). 2023;42(11):2116-2123
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Malnutrition in hospitalised adults is recognized as a challenging health concern that is associated with many adverse outcomes. Malnutrition screening and assessment are essential for all patients admitted to the hospital and are particularly important for adults who are vulnerable. The aim of this study was to determine whether specialised oral-nutritional supplements (S-ONS) benefits were further associated with measurable improvements in quality of life (QoL) domains during the post-hospitalisation period. This study was a post-hoc analysis of NOURISH trial data. The NOURISH trial was a multicentre, prospective, randomised, double-blind, placebo-controlled, parallel-group study. Six-hundred and twenty-two patients were included in the intent-to-treat analysis. Results showed that malnourished, older patients who received daily interventions with S-ONS (during hospital stay and for 90-day post-discharge) had significantly better QoL domain scores compared to those who received only placebo intervention. Specifically, there were significant differences in the QoL domains of mental health/ cognition, vitality, social functioning, and general health. Further, there were significant QoL differences for physical component, physical functioning, bodily pain, and emotional role. Authors concluded that among malnourished, hospitalised patients (aged 65 years and over), supplementation with S-ONS during the hospitalisation and 90-days post discharge resulted in improvements in QoL.
Abstract
BACKGROUND & AIMS Both during and after hospitalization, nutritional care with daily intake of oral nutritional supplements (ONS) improves health outcomes and decreases risk of mortality in malnourished older adults. In a post-hoc analysis of data from hospitalized older adults with malnutrition risk, we sought to determine whether consuming a specialized ONS (S-ONS) containing high protein and beta-hydroxy-beta-methylbutyrate (HMB) can also improve Quality of Life (QoL). METHODS We analyzed data from the NOURISH trial-a randomized, placebo-controlled, multi-center, double-blind study conducted in patients with congestive heart failure, acute myocardial infarction, pneumonia, or chronic obstructive pulmonary disease. Patients received standard care + S-ONS or placebo beverage (target 2 servings/day) during hospitalization and for 90 days post-discharge. SF-36 and EQ-5D QoL outcomes were assessed at 0-, 30-, 60-, and 90-days post-discharge. To account for the missing QoL observations (27.7%) due to patient dropout, we used multiple imputation. Data represent differences between least squares mean (LSM) values with 95% Confidence Intervals for groups receiving S-ONS or placebo treatments. RESULTS The study population consisted of 622 patients of mean age ±standard deviation: 77.9 ± 8.4 years and of whom 52.1% were females. Patients consuming placebo had lower (worse) QoL domain scores than did those consuming S-ONS. Specifically for the SF-36 health domain scores, group differences (placebo vs S-ONS) in LSM were significant for the mental component summary at day 90 (-4.23 [-7.75, -0.71]; p = 0.019), the domains of mental health at days 60 (-3.76 [-7.40, -0.12]; p = 0.043) and 90 (-4.88 [-8.41, -1.34]; p = 0.007), vitality at day 90 (-3.33 [-6.65, -0.01]; p = 0.049) and social functioning at day 90 (-4.02 [-7.48,-0.55]; p = 0.023). Compared to placebo, differences in LSM values for the SF-36 general health domain were significant with improvement in the S-ONS group at hospital discharge and beyond: day 0 (-2.72 [-5.33, -0.11]; p = 0.041), day 30 (-3.08 [-6.09, -0.08]; p = 0.044), day 60 (-3.95 [-7.13, -0.76]; p = 0.015), and day 90 (-4.56 [-7.74, -1.38]; p = 0.005). CONCLUSIONS In hospitalized older adults with cardiopulmonary diseases and evidence of poor nutritional status, daily intake of S-ONS compared to placebo improved post-discharge QoL scores for mental health/cognition, vitality, social functioning, and general health. These QoL benefits complement survival benefits found in the original NOURISH trial analysis. CLINICAL TRIAL REGISTRATION NCT01626742.
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Effects of an educational intervention on frailty status, physical function, physical activity, sleep patterns, and nutritional status of older adults with frailty or pre-frailty: the FRAGSALUD study.
Casals, C, Ávila-Cabeza-de-Vaca, L, González-Mariscal, A, Marín-Galindo, A, Costilla, M, Ponce-Gonzalez, JG, Vázquez-Sánchez, MÁ, Corral-Pérez, J
Frontiers in public health. 2023;11:1267666
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Frailty and pre-frailty are associated with an increased risk of premature mortality. Factors involved in the development of frailty include physical activity, sleep and nutrition. The aim of this 6-month randomised controlled trial was to evaluate the effects of an educational programme on frailty, physical function, physical activity, sleep and nutritional status. 166 community-dwelling individuals aged 65 years or over with frailty or pre-frailty were randomised to either receive a health education programme consisting of 4 group sessions in the first month which included guidelines for physical activity, nutrition and cognitive training as well as the promotion of psychological and social wellbeing and 6 follow-up calls over 6 months or their usual healthcare (control). Compared to the control group, the intervention group had significant reductions in frailty score, exhaustion and fatigue score, increase in gait speed and improvements in various physical function tests. The intervention group also showed significant improvements in mini nutritional assessment compared to the control group although this was not associated with significant changes in anthropometric parameters. There was a significant increase in awakenings in the control group whilst this parameter did not change in the intervention group, whilst there were no changes in other sleep parameters. The authors concluded that the simplicity, affordability and effectiveness of the health education programme may contribute to healthy ageing.
Expert Review
Conflicts of interest:
None
Take Home Message:
To improve frailty and physical functioning, a comprehensive programme may be effective, which includes:
- Nutrition
- Physical exercise
- Cognitive training
- Promotion of social and psychological wellbeing.
Evidence Category:
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X
A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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B: Systematic reviews including RCTs of limited number
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C: Non-randomized trials, observational studies, narrative reviews
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D: Case-reports, evidence-based clinical findings
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E: Opinion piece, other
Summary Review:
Introduction
- Frailty and pre-frailty increase the risk of premature mortality but are reversible
- The aim of this study was to evaluate the effects of a health education programme on frailty status in frail or pre-frail older persons.
Methods
- Randomised controlled trial
- Participants: 166 community-dwelling individuals aged 65 years or over with frailty or pre-frailty living in Spain were enrolled, 163 completed the study (80 in intervention and 83 in control group)
- Four weekly group sessions which included guidelines for physical activity, nutrition and cognitive training as well as the promotion of psychological and social wellbeing and 6 follow-up calls over 6 months versus usual healthcare (control).
Results
- Baseline demographics: The educational group consisted of more women (p=0.001), had a younger average age (p=0.019), lower height (p=0.001) and a higher average education level (p=0.013) compared to the control group.
Effects on intervention group:
- Reductions in frailty score (p<0.05 vs baseline and change vs change in control group), with 30% of participants in the intervention group no longer being classified as frail or pre-frail in contrast to none in the control group
- Reductions in fatigue and exhaustion score (p<0.05 vs baseline and change vs change in control group)
- Increase in gait speed and improvements in various physical function tests (all p<0.05 vs baseline and change vs change in control group)
- Improvements in mini nutritional assessment (p<0.001 vs baseline and change vs change in control group)
- Improvement in sleep behaviour demonstrated by an increase in awakenings in the control group (p<0.05 vs baseline and change vs change in intervention group) whilst this parameter did not change in the intervention group.
No effects (vs control) on:
- Anthropometric parameters/unintended weight loss
- Other sleep parameters
- Physical activity expenditure and physical activity score
- Hand grip strength.
Conclusion
This affordable and simple health education programme is effective in reducing frailty in elderly and may contribute to healthy ageing.
Clinical practice applications:
- A comprehensive programme, encompassing not only nutrition, but also exercise, cognitive training and a focus on social and psychological wellbeing may be most effective in improving frailty and physical functioning
- Nutrition intervention, alongside other lifestyle interventions, may have benefits for nutritional status in older adults, even if this is not reflected in a change in anthropometric parameters, such as weight.
Considerations for future research:
- Studies with longer-term follow-up would help evaluate whether/for how long the benefits are sustained.
Abstract
INTRODUCTION The prevalence of frailty is increasing worldwide, emphasizing the importance of prioritizing healthy ageing. To address this, cost-effective and minimally supervised interventions are being sought. This study aimed to assess the impact of an educational program on frailty status, physical function, physical activity, sleep patterns, and nutritional status in community-dwelling older adults with at least 1 Fried's frailty criteria. METHODS A 6-month multicentre randomized controlled trial was conducted from March 2022 to February 2023 in 14 health centres located in Cadiz and Malaga, Spain. The educational intervention consisted of 4 group sessions and 6 follow-up phone calls spread over 6 months. The program focused on educating participants about frailty and its impact on health, providing guidelines for physical activity, healthy dietary habits, cognitive training, psychological well-being and social activities. A total of 163 participants, divided into control (n = 80) and educational groups (n = 83) were assessed before and after the intervention. RESULTS The results showed a significant group-time interaction in the physical function evaluated with a large effect on Short Physical Performance Battery score (η2p = 0.179, -0.1 [-1.2-1.0] points for control group vs. 1.0 [0.0-3.0] points for educational group, p < 0.001), and an effect on the 4-meter gait test ((η2p = 0.122, 0.5 [0.1-0.0] s for control group vs. -0.4 [-0.5- -0.3] s for educational group, p < 0.001), and the 5-repetition sit-to-stand test (η2p = 0.136, 1.0 [0.0-1.2] s for control group vs. -4.3 [-7.0- -2.3] for educational group, p < 0.001). Additionally, the use of accelerometers to assess physical activity, inactivity, and sleep patterns revealed a significant small effect in the number of awakenings at night ((η2p = 0.040, 1.1 [-0.5-3.4] awakenings for control group vs. 0.0 [-2.2-0.0] awakenings for educational group, p = 0.009). The findings also highlighted a significant medium effect regarding malnutrition risk, which was assessed using the Mini-Nutritional Assessment score (η2p = 0.088, -0.7 [-2.3-1.5] points for control group vs. 1.5 [-0.5-3.0] points for educational group, p < 0.001). DISCUSSION Thus, the 6-month educational program effectively improved physical function, sleep patterns, and nutritional status compared to usual healthcare attendance in community-dwelling older adults with frailty or pre-frailty. These findings underscore the potential of minimally supervised interventions in promoting a healthy lifestyle in this vulnerable population.
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Adherence to Mediterranean Diet and NAFLD in Patients with Metabolic Syndrome: The FLIPAN Study.
Montemayor, S, Mascaró, CM, Ugarriza, L, Casares, M, Llompart, I, Abete, I, Zulet, MÁ, Martínez, JA, Tur, JA, Bouzas, C
Nutrients. 2022;14(15)
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Non-alcoholic fatty liver disease (NAFLD) is characterised by fat deposition that is not linked to excessive alcohol intake. This condition is often linked to other health issues such as obesity, metabolic syndrome, type 2 diabetes and cardiovascular disease, and they share common diagnostic biomarkers. An unhealthy diet and lifestyle are also linked to the progression of NAFLD. Mediterranean diet is a predominantly plant-based diet that may have an association with lower risk and reduced severity of NAFLD. This multicentre, prospective, randomised controlled trial included one hundred and thirty-six NAFLD patients to analyse the effect of Mediterranean diet adherence on NAFLD in patients with metabolic syndrome. The NAFLD patients followed a personalised Mediterranean diet and physical activity interventions for six months. Individuals with greater adherence to the Mediterranean diet and physical activity interventions showed improvements in body mass index, body weight, waist circumference, blood pressure and intrahepatic fat content after six months of intervention. Healthcare professionals can use the results of this study to understand the benefits of adherence to the Mediterranean diet and physical activity interventions in reducing NAFLD severity and metabolic irregularities. However, due to the small sample size of this study, further robust studies are required to evaluate the benefits of different dietary strategies, the therapeutic value of different food items and the intervention duration required to achieve improvements in NAFLD and metabolic syndrome.
Abstract
Unhealthy diet is an important factor in the progression of non-alcoholic fatty liver disease (NAFLD). Previous studies showed the benefits of a Mediterranean diet (MedDiet) on Metabolic syndrome (MetS), type 2 diabetes mellitus (T2DM), and cardiovascular diseases, which usually have a pathophysiological relationship with NAFLD. To assess the effect of adherence to a MedDiet on NAFLD in MetS patients after lifestyle intervention, this multicentre (Mallorca and Navarra, Spain) prospective randomized trial, with personalized nutritional intervention based on a customized MedDiet, coupled with physical activity promotion was performed to prevent, and reverse NAFLD among patients with MetS. The current analysis included 138 patients aged 40 to 60 years old, Body Mass Index (BMI) 27-40 kg/m2, diagnosed with NAFLD using MRI, and MetS according to the International Diabetes Federation (IDF). A validated food frequency questionnaire was used to assess dietary intake. Adherence to Mediterranean diet by means of a 17-item validated questionnaire, anthropometrics, physical activity, blood pressure, blood biochemical parameters, and intrahepatic fat contents (IFC) were measured. The independent variable used was changes in MedDiet adherence, categorized in tertiles after 6 months follow-up. Subjects with high adherence to the MedDiet showed higher decreases in BMI, body weight, WC, SBP, DBP, and IFC. An association between improvement in adherence to the MedDiet and amelioration of IFC after 6-month follow-up was observed. High adherence to the MedDiet is associated with better status of MetS features, and better values of IFC.
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Effect of High-Intensity Interval Training, Moderate Continuous Training, or Guideline-Based Physical Activity Advice on Peak Oxygen Consumption in Patients With Heart Failure With Preserved Ejection Fraction: A Randomized Clinical Trial.
Mueller, S, Winzer, EB, Duvinage, A, Gevaert, AB, Edelmann, F, Haller, B, Pieske-Kraigher, E, Beckers, P, Bobenko, A, Hommel, J, et al
JAMA. 2021;325(6):542-551
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Heart failure with preserved ejection fraction (HFpEF) is a condition in which the heart's lower left chamber is less able to pump blood due to stiffness. The prevalence of HFpEF is high among the elderly. Endurance exercise is known to increase peak oxygen consumption (Vo2). This prospective, randomised, controlled, three-armed, multi-centre trial aimed to understand the effects of endurance training in older people with HFpEF at 3 and 12 months. In this study, 180 sedentary patients with HFpEF were randomly assigned to high-intensity interval training, moderate continuous training, or control of home-based tele-guideline physical activity advice. The study found no statistically significant difference in changes in V̇o2 between high-intensity interval and moderate continuous training, and neither group met the clinically significant difference of 2.5 mL/kg/min compared with the guideline control. Diastolic function or natriuretic peptides did not change significantly in any group. Adherence level was lower among elderly patients, and there were serious adverse effects in patients with HFpEE. Healthcare professionals can use the findings of this study to understand the impact and adverse effects of endurance training at different intensities in patients with HFpEE.
Abstract
Importance: Endurance exercise is effective in improving peak oxygen consumption (peak V̇o2) in patients with heart failure with preserved ejection fraction (HFpEF). However, it remains unknown whether differing modes of exercise have different effects. Objective: To determine whether high-intensity interval training, moderate continuous training, and guideline-based advice on physical activity have different effects on change in peak V̇o2 in patients with HFpEF. Design, Setting, and Participants: Randomized clinical trial at 5 sites (Berlin, Leipzig, and Munich, Germany; Antwerp, Belgium; and Trondheim, Norway) from July 2014 to September 2018. From 532 screened patients, 180 sedentary patients with chronic, stable HFpEF were enrolled. Outcomes were analyzed by core laboratories blinded to treatment groups; however, the patients and staff conducting the evaluations were not blinded. Interventions: Patients were randomly assigned (1:1:1; n = 60 per group) to high-intensity interval training (3 × 38 minutes/week), moderate continuous training (5 × 40 minutes/week), or guideline control (1-time advice on physical activity according to guidelines) for 12 months (3 months in clinic followed by 9 months telemedically supervised home-based exercise). Main Outcomes and Measures: Primary end point was change in peak V̇o2 after 3 months, with the minimal clinically important difference set at 2.5 mL/kg/min. Secondary end points included changes in metrics of cardiorespiratory fitness, diastolic function, and natriuretic peptides after 3 and 12 months. Results: Among 180 patients who were randomized (mean age, 70 years; 120 women [67%]), 166 (92%) and 154 (86%) completed evaluation at 3 and 12 months, respectively. Change in peak V̇o2 over 3 months for high-intensity interval training vs guideline control was 1.1 vs -0.6 mL/kg/min (difference, 1.5 [95% CI, 0.4 to 2.7]); for moderate continuous training vs guideline control, 1.6 vs -0.6 mL/kg/min (difference, 2.0 [95% CI, 0.9 to 3.1]); and for high-intensity interval training vs moderate continuous training, 1.1 vs 1.6 mL/kg/min (difference, -0.4 [95% CI, -1.4 to 0.6]). No comparisons were statistically significant after 12 months. There were no significant changes in diastolic function or natriuretic peptides. Acute coronary syndrome was recorded in 4 high-intensity interval training patients (7%), 3 moderate continuous training patients (5%), and 5 guideline control patients (8%). Conclusions and Relevance: Among patients with HFpEF, there was no statistically significant difference in change in peak V̇o2 at 3 months between those assigned to high-intensity interval vs moderate continuous training, and neither group met the prespecified minimal clinically important difference compared with the guideline control. These findings do not support either high-intensity interval training or moderate continuous training compared with guideline-based physical activity for patients with HFpEF. Trial Registration: ClinicalTrials.gov Identifier: NCT02078947.
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Association of Major Dietary Protein Sources With All-Cause and Cause-Specific Mortality: Prospective Cohort Study.
Sun, Y, Liu, B, Snetselaar, LG, Wallace, RB, Shadyab, AH, Kroenke, CH, Haring, B, Howard, BV, Shikany, JM, Valdiviezo, C, et al
Journal of the American Heart Association. 2021;10(5):e015553
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Dietary recommendations for human health focusing on total protein intake without considering specific protein sources may be simplistic and insufficient. The aim of this study was to investigate whether different dietary protein sources would be differentially associated with mortality risk. The study is based on data from a large prospective cohort study with up to 18-years of follow-up to investigate the risks of all-cause and cause-specific mortality in relation to animal and plant protein intake, and major sources of dietary protein. Results indicate that intake of plant protein and substitution of animal protein with plant protein, were associated with lower risk of all-cause, cardiovascular disease, and dementia mortality. Furthermore, substitution of red meat, eggs, dairy products, or legumes with nuts was associated with lower risk of all-cause mortality. Authors conclude that their findings support the need for consideration of protein sources, in addition to the amount of protein intake, in future dietary guidelines.
Abstract
Background Dietary recommendations regarding protein intake have been focused on the amount of protein. However, such recommendations without considering specific protein sources may be simplistic and insufficient. Methods and Results We included 102 521 postmenopausal women enrolled in the Women's Health Initiative between 1993 and 1998, and followed them through February 2017. During 1 876 205 person-years of follow-up, 25 976 deaths occurred. Comparing the highest with the lowest quintile, plant protein intake was inversely associated with all-cause mortality (hazard ratio [HR], 0.91 [0.86, 0.96]), cardiovascular disease mortality (HR, 0.88 [0.79, 0.97]), and dementia mortality (HR, 0.79 [0.67, 0.94]). Among major protein sources, comparing the highest with the lowest quintile of consumption, processed red meat (HR, 1.06 [1.01, 1.10]) or eggs (HR, 1.14 [1.10, 1.19]) was associated with higher risk of all-cause mortality. Unprocessed red meat (HR, 1.12 [1.02, 1.23]), eggs (HR, 1.24 [1.14, 1.34]), or dairy products (HR, 1.11 [1.02, 1.22]) was associated with higher risk of cardiovascular disease mortality. Egg consumption was associated with higher risk of cancer mortality (HR, 1.10 [1.02, 1.19]). Processed red meat consumption was associated with higher risk of dementia mortality (HR, 1.20 [1.05, 1.32]), while consumption of poultry (HR, 0.85 [0.75, 0.97]) or eggs (HR, 0.86 [0.75, 0.98]) was associated with lower risk of dementia mortality. In substitution analysis, substituting of animal protein with plant protein was associated with a lower risk of all-cause mortality, cardiovascular disease mortality, and dementia mortality, and substitution of total red meat, eggs, or dairy products with nuts was associated with a lower risk of all-cause mortality. Conclusions Different dietary protein sources have varying associations with all-cause mortality, cardiovascular disease mortality, and dementia mortality. Our findings support the need for consideration of protein sources in future dietary guidelines.
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Usefulness of a Lifestyle Intervention in Patients With Cardiovascular Disease.
Broers, ER, Gavidia, G, Wetzels, M, Ribas, V, Ayoola, I, Piera-Jimenez, J, Widdershoven, JWMG, Habibović, M
The American journal of cardiology. 2020;125(3):370-375
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Modifiable (behavioural) risk factors such as sedentary lifestyle and low sleep efficiency, are associated with increased mortality risk and disease progression in individuals with cardiovascular disease. The main aim of this study was to evaluate changes in objectively measured lifestyle and health data derived from wearable devices. This study was part of an international, multicenter randomized controlled trial, the Do Cardiac Health Advanced New Generation Ecosystem 2 study. Only the participants (n=70) randomised to the intervention group were analysed. The participants received the devices to monitor their lifestyle and health parameters. Results indicate significant changes over time in the number of steps and activity level. No significant improvement over time was observed in other outcome measures (i.e., blood pressure, weight, and sleep efficiency). Secondary analysis showed demographic (gender, nationality, marital status), clinical (co-morbidities, heart failure), and psychological (anxiety, depression) profiles that were associated with lifestyle measures. Authors conclude that a personalised approach might be the way forward in order to improve health outcomes in the future.
Abstract
The importance of modifying lifestyle factors in order to improve prognosis in cardiac patients is well-known. Current study aims to evaluate the effects of a lifestyle intervention on changes in lifestyle- and health data derived from wearable devices. Cardiac patients from Spain (n = 34) and The Netherlands (n = 36) were included in the current analysis. Data were collected for 210 days, using the Fitbit activity tracker, Beddit sleep tracker, Moves app (GPS tracker), and the Careportal home monitoring system. Locally Weighted Error Sum of Squares regression assessed trajectories of outcome variables. Linear Mixed Effects regression analysis was used to find relevant predictors of improvement deterioration of outcome measures. Analysis showed that Number of Steps and Activity Level significantly changed over time (F = 58.21, p < 0.001; F = 6.33, p = 0.01). No significant changes were observed on blood pressure, weight, and sleep efficiency. Secondary analysis revealed that being male was associated with higher activity levels (F = 12.53, p < 0.001) and higher number of steps (F = 8.44, p < 0.01). Secondary analysis revealed demographic (gender, nationality, marital status), clinical (co-morbidities, heart failure), and psychological (anxiety, depression) profiles that were associated with lifestyle measures. In conclusion results showed that physical activity increased over time and that certain subgroups of patients were more likely to have a better lifestyle behaviors based on their demographic, clinical, and psychological profile. This advocates a personalized approach in future studies in order to change lifestyle in cardiac patients.
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Interaction Between Type 2 Diabetes Prevention Strategies and Genetic Determinants of Coronary Artery Disease on Cardiometabolic Risk Factors.
Merino, J, Jablonski, KA, Mercader, JM, Kahn, SE, Chen, L, Harden, M, Delahanty, LM, Araneta, MRG, Walford, GA, Jacobs, SBR, et al
Diabetes. 2020;69(1):112-120
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Individual risk of Coronary Artery Disease (CAD) and type 2 diabetes reflects the interplay between lifestyle behaviours acting on a backdrop of genetic predisposition. The aim of this study was to examine whether type 2 diabetes prevention strategies, either an intensive lifestyle intervention (ILS) or metformin treatment (MET), modify the association between CAD genetic risk and cardiometabolic risk factors (CRFs) in participants at high risk of type 2 diabetes. The study is a randomised controlled trial were participants were randomly allocated to one of the three groups; ILS (n = 1,079), MET (850 mg twice daily [n = 1,073]), or placebo (n = 1,082). Results indicate that there weren’t major significant differences in baseline characteristics, except for lower high-density lipoprotein and higher triglyceride in the placebo individuals compared with individuals assigned to MET or ILS. In fact, either an ILS or MET has a beneficial effect on 1-year change in different CRFs. Authors conclude that type 2 diabetes–preventive strategies for individuals at high risk of type 2 diabetes provide beneficial effects on CRFs regardless of CAD genetic risk profile.
Abstract
Coronary artery disease (CAD) is more frequent among individuals with dysglycemia. Preventive interventions for diabetes can improve cardiometabolic risk factors (CRFs), but it is unclear whether the benefits on CRFs are similar for individuals at different genetic risk for CAD. We built a 201-variant polygenic risk score (PRS) for CAD and tested for interaction with diabetes prevention strategies on 1-year changes in CRFs in 2,658 Diabetes Prevention Program (DPP) participants. We also examined whether separate lifestyle behaviors interact with PRS and affect changes in CRFs in each intervention group. Participants in both the lifestyle and metformin interventions had greater improvement in the majority of recognized CRFs compared with placebo (P < 0.001) irrespective of CAD genetic risk (P interaction > 0.05). We detected nominal significant interactions between PRS and dietary quality and physical activity on 1-year change in BMI, fasting glucose, triglycerides, and HDL cholesterol in individuals randomized to metformin or placebo, but none of them achieved the multiple-testing correction for significance. This study confirms that diabetes preventive interventions improve CRFs regardless of CAD genetic risk and delivers hypothesis-generating data on the varying benefit of increasing physical activity and improving diet on intermediate cardiovascular risk factors depending on individual CAD genetic risk profile.
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Total and Subtypes of Dietary Fat Intake and Its Association with Components of the Metabolic Syndrome in a Mediterranean Population at High Cardiovascular Risk.
Julibert, A, Bibiloni, MDM, Bouzas, C, Martínez-González, MÁ, Salas-Salvadó, J, Corella, D, Zomeño, MD, Romaguera, D, Vioque, J, Alonso-Gómez, ÁM, et al
Nutrients. 2019;11(7)
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Obesity, Metabolic Syndrome (MetS) and Cardiovascular Disease (CVD) are becoming a global epidemic and the role of dietary fats is still unclear. The PREDIMED trial is a large study of 6560 Mediterranean men and women, aged 55–75 years old, with overweight/obesity and MetS in which they have tracked all types of dietary fat consumed over a 6-year period to assess the risk factors for CVD. Quality of fat is thought to play an important role in MetS. This study used food questionnaires to measure intake of the following fats: total fat, monounsaturated fatty acids: MUFA, polyunsaturated fatty acids: PUFA, saturated fatty acids: SFA, trans-fatty acids: trans-FA, linoleic acid, a-linolenic acid, and w-3 FA). They were able to divide the participants into groups ranging from highest to lowest fat intake and assess the types of foods and fats being consumed. They found that the group with the highest fat intakes ate less carbohydrates, protein and fibre and had a higher risk of hyperglycaemia (high blood glucose levels). The total fats consumed in this group also included high levels of harmful trans-fatty acids so the researchers concluded that the risk is influenced by the combination of nutrients of the food consumed. They also found that participants who consumed high levels of linoleic acid had significantly higher healthy HDL cholesterol levels and those who consumed high levels of saturated fatty acids and omega 3 had significantly less risk of high triglycerides (another cholesterol marker). Overall they recommend further studies into types of dietary fat to help reduce MetS in the population.
Abstract
Background: The effect of dietary fat intake on the metabolic syndrome (MetS) and in turn on cardiovascular disease (CVD) remains unclear in individuals at high CVD risk. Objective: To assess the association between fat intake and MetS components in an adult Mediterranean population at high CVD risk. Design: Baseline assessment of nutritional adequacy in participants (n = 6560, men and women, 55-75 years old, with overweight/obesity and MetS) in the PREvención con DIeta MEDiterránea (PREDIMED)-Plus randomized trial. Methods: Assessment of fat intake (total fat, monounsatured fatty acids: MUFA, polyunsaturated fatty acids: PUFA, saturated fatty acids: SFA, trans-fatty acids: trans-FA, linoleic acid, α-linolenic acid, and ω-3 FA) using a validated food frequency questionnaire, and diet quality using 17-item Mediterranean dietary questionnaire and fat quality index (FQI). Results: Participants in the highest quintile of total dietary fat intake showed lower intake of energy, carbohydrates, protein and fiber, but higher intake of PUFA, MUFA, SFA, TFA, LA, ALA and ω-3 FA. Differences in MetS components were found according to fat intake. Odds (5th vs. 1st quintile): hyperglycemia: 1.3-1.6 times higher for total fat, MUFA, SFA and ω-3 FA intake; low high-density lipoprotein cholesterol (HDL-c): 1.2 higher for LA; hypertriglyceridemia: 0.7 lower for SFA and ω-3 FA intake. Conclusions: Dietary fats played different role on MetS components of high CVD risk patients. Dietary fat intake was associated with higher risk of hyperglycemia.
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One- and Two-Year Effects of the Healthy Primary School of the Future on Children's Dietary and Physical Activity Behaviours: A Quasi-Experimental Study.
Bartelink, NHM, van Assema, P, Kremers, SPJ, Savelberg, HHCM, Oosterhoff, M, Willeboordse, M, van Schayck, OCP, Winkens, B, Jansen, MWJ
Nutrients. 2019;11(3)
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Diet and Physical Activity (PA) habits are formed at a young age, and unhealthy habits can lead to childhood obesity and lifelong health problems. Schools are globally recognised as having access to children across all socio-economic backgrounds and to play an important role in influencing healthy habits. This Dutch experimental longitudinal study looks at the impact Primary schools can have on the health of their students by implementing a dedicated Nutrition and PA Program called ‘Healthy Primary Schools for the Future (HPSF), modelled on an American initiative, piloted in 4 schools and 2 control schools. The study tests whether a fully implemented program (focused on Nutrition and PA - including free lunches & daily PA sessions) or a partial program (focused only on PA sessions) influences healthy change in children’s behaviours versus control schools (no program). The data from 1676 children aged 4-12 yrs was used and the study took place over 3 yrs (2015-2017) with a commitment to continue till 2019 where follow-up data could be obtained. The data was collected once a year using parental and child questionnaires. Additional movement data was obtained from accelerometers the children wore for 7 days during each annual measurement week. The results at year 3 show that a combined nutrition and PA program had greatest benefits on improving diet (variety of foods eaten), and reducing unhealthy snacking, and increasing PA. Neither the partial program or control schools displayed positive changes. The researchers reflect that the full program allowed greater involvement from all parties involved (schools, parents, children’s, educational and health partners) which led to changes becoming an integral part of the school routine. Focusing on nutrition and PA together seemed to encourage complementary behavioural changes compared to focusing only on PA.
Abstract
Schools can help to improve children's health. The 'Healthy Primary School of the Future' (HPSF) aims to sustainably integrate health and well-being into the school system. This study examined the effects of HPSF on children's dietary and physical activity (PA) behaviours after 1 and 2 years' follow-up. The study (n = 1676 children) has a quasi-experimental design with four intervention schools, i.e., two full HPSF (focus: nutrition and PA) and two partial HPSF (focus: PA), and four control schools. Accelerometers and child- and parent-reported questionnaires were used at baseline, after 1 (T1) and 2 (T2) years. Mixed-model analyses showed significant favourable effects for the full HPSF versus control schools for, among others, school water consumption (effect size (ES) = 1.03 (T1), 1.14 (T2)), lunch intake of vegetables (odds ratio (OR) = 3.17 (T1), 4.39 (T2)) and dairy products (OR = 4.43 (T1), 4.52 (T2)), sedentary time (ES = -0.23 (T2)) and light PA (ES = 0.22 (T2)). Almost no significant favourable effects were found for partial HPSF compared to control schools. We conclude that the full HPSF is effective in promoting children's health behaviours at T1 and T2 compared with control schools. Focusing on both nutrition and PA components seems to be more effective in promoting healthy behaviours than focusing exclusively on PA.