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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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Intra-pancreatic fat is associated with high circulating glucagon and GLP-1 concentrations following whey protein ingestion in overweight women with impaired fasting glucose: A randomised controlled trial.
Lim, JJ, Sequeira-Bisson, IR, Yip, WCY, Lu, LW, Miles-Chan, JL, Poppitt, SD
Diabetes research and clinical practice. 2024;207:111084
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Dietary protein may play a unique role in maintaining glucose homeostasis. Whey protein has been proposed to improve postprandial glycaemia in the prevention and treatment of type-2 diabetes. This observational study aimed to investigate the association of intra-pancreatic fat deposition (IPFD) on markers of pancreatic cell function after using whey protein. Twenty-four women living with overweight, who had impaired fasting glucose (IFG) were enrolled and randomised. They underwent magnetic resonance imaging and spectroscopy (MRI/S) in a fasted state, to assess intra-pancreatic and intra-hepatic fat deposition. The study was a 3-arm single-blind, cross-over trial with all participants trialing 3g of whey protein, a low dose whey protein 12.5 g, a high-dose whey protein 50g and a water control, with a seven day wash out period. The results found the women with high intra-pancreatic fat deposition had higher circulating levels of two pancreatic hormones following an oral load of whey protein: glucagon-like peptide-1 (GLP-1); and glucagon. No impact was seen on insulin secretion. The authors conclude that the observations may help to explain the variability of the glucagon-like peptide-1 response in a population with pre-diabetes. The cause for elevated blood glucose is multifactorial and the differences could also be from adaptive responses. Moreover, further investigations are required to translate the findings to a mixed gender population with different glycaemic status.
Abstract
AIM: Intra-pancreatic fat deposition (IPFD) while hypothesised to impair beta-cell function, its impact on alpha-cells remains unclear. We evaluated the association between IPFD and markers of pancreatic cells function using whey protein. METHODS Twenty overweight women with impaired fasting glucose (IFG) and low or high IPFD (<4.66% vs ≥4.66%) consumed 3 beverage treatments: 0 g (water control), 12.5 g (low-dose) and 50.0 g (high-dose) whey protein, after an overnight fast, in randomised order. Blood glucose, insulin, C-peptide, glucagon, gastric-inhibitory polypeptide (GIP), glucagon-like peptide-1 (GLP-1) and amylin were analysed postprandially over 4 h. Incremental area-under-the-curve (iAUC), incremental maximum concentration (iCmax), and time to maximum concentration (Tmax) for these were compared between IPFD groups using repeated measures linear mixed models, also controlled for age (pcov). RESULTS iAUC and iCmax glucose and insulin while similar between the two IPFD groups, high IPFD and ageing contributed to higher postprandial glucagon (iAUC: p = 0.012; pcov = 0.004; iCmax: p = 0.069; pcov = 0.021) and GLP-1 (iAUC: p = 0.006; pcov = 0.064; iCmax: p = 0.011; pcov = 0.122) concentrations. CONCLUSION In our cohort, there was no evidence that IPFD impaired protein-induced insulin secretion. Conversely, IPFD may be associated with increased protein-induced glucagon secretion, a novel observation which warrants further investigation into its relevance in the pathogenesis of dysglycaemia and type-2 diabetes.
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Exercise intervention in middle-aged and elderly individuals with insomnia improves sleep and restores connectivity in the motor network.
Chen, R, Wang, S, Hu, Q, Kang, N, Xie, H, Liu, M, Shan, H, Long, Y, Hao, Y, Qin, B, et al
Translational psychiatry. 2024;14(1):159
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Insomnia is highly prevalent in older adults. Exercise intervention has been recognized as a potential treatment to improve sleep. The most frequent exercise intervention includes aerobic and resistance exercise. The aim of this study was to identify the effects of a 12-week exercise program on sleep quality and brain functional connectivity in middle-aged and older adults with insomnia. This study was a randomised controlled trial. Ninety-two participants were randomly assigned to one of the two groups (exercise vs control group). Results showed that middle-aged and older adults with insomnia had decreases in both subjective and objective sleep quality. At the level of brain circuits, individuals with insomnia exhibited reduced connectivity within the extensive motor network. Following the exercise intervention, participants in the exercise group reported an improvement in sleep quality. Authors concluded that exercise intervention improved insomnia symptoms and motor network connectivity. Additionally, they underscore the potential to enhance sleep quality and promote brain plasticity in aging individuals through exercise intervention.
Abstract
Exercise is a potential treatment to improve sleep quality in middle-aged and elderly individuals. Understanding exercise-induced changes in functional plasticity of brain circuits that underlie improvements in sleep among middle-aged and older adults can inform treatment of sleep problems. The aim of the study is to identify the effects of a 12-week exercise program on sleep quality and brain functional connectivity in middle-aged and older adults with insomnia. The trial was registered with Chinese Clinical Trial Register (ChiCTR2000033652). We recruited 84 healthy sleepers and 85 individuals with insomnia. Participants with insomnia were assigned to receive either a 12-week exercise intervention or were placed in a 12-week waitlist control condition. Thirty-seven middle-aged and older adults in the exercise group and 30 in the waitlist group completed both baseline and week 12 assessments. We found that middle-aged and older adults with insomnia showed significantly worse sleep quality than healthy sleepers. At the brain circuit level, insomnia patients showed decreased connectivity in the widespread motor network. After exercise intervention, self-reported sleep was increased in the exercise group (P < 0.001) compared to that in the waitlist group. We also found increased functional connectivity of the motor network with the cerebellum in the exercise group (P < 0.001). Moreover, we observed significant correlations between improvement in subjective sleep indices and connectivity changes within the motor network. We highlight exercise-induced improvement in sleep quality and functional plasticity of the aging brain.
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Body composition, balance, functional capacity and falls in older women.
Nordling, Y, Sund, R, Sirola, J, Kröger, H, Isanejad, M, Rikkonen, T
Aging clinical and experimental research. 2024;36(1):76
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Falls among older women are a significant health concern, often leading to injuries and reduced quality of life. Loss of muscle strength and functional capacity are among significant physiological changes among the older population. The aim of this study was to investigate how different factors such as body composition, balance, and functional capacity contribute to the incidence of falls and the severity of fall-related injuries in older women. This study was a 2-year randomised controlled trial involving 914 women, with an average age of 76.5 years. Results showed that 59.7% of participants experienced a fall during the follow-up period. Higher femoral neck bone mineral density was linked to a higher overall risk of falls but was protective against severe fall injuries. Conversely, slower Timed Up and Go (TUG) test results indicated an increased risk of falls and injuries requiring medical attention. Authors concluded that while certain physical attributes may predispose older women to more frequent falls, they also provide some protection against severe injuries. In fact, it highlights the importance of tailored interventions that consider individual functional capacities to prevent falls and related injuries.
Abstract
BACKGROUND The aim of this study was to examine the association of body composition, muscle strength, balance, and functional capacity on falls and fall injuries among community-dwelling older women. METHODS The study comprised of a 2-year randomized controlled trial involving 914 women with an average age of 76.5 (SD = 3.3) years at baseline. The women were assigned to exercise intervention (n = 457) and control groups (n = 457). Clinical measurements were conducted at baseline, 12 months and 24 months. RESULTS During the 2-year follow up, total of 546 women (59.7%) sustained a fall. The total number of falls was 1380 and out of these, 550 (40%) of falls were non-injurious and 745 (54%) were injurious. Higher femoral neck bone mineral density (BMD) was associated with a higher overall risk of falls [RR = 2.55 (95% CI = 1.70-3.84, p < 0.001)], but was a protective factor for severe fall injuries [RR = 0.03 (95% CI = 0.003-0.035, p < 0.01)]. Slower Timed Up and Go (TUG) was associated with an increased overall risk of falls [RR = 1.07 (95% CI = 1.05-1.10, p < 0.001)] and injuries requiring medical attention [RR = 1.10 (95% CI = 1.02-1.19, p = 0.02)]. Longer single leg standing time was a protective factor for falls [RR = 0.99 (95% CI = 0.99-1.00, p < 0.01)] and overall injurious falls [RR = 0.99 (95% CI = 0.99-1.00, p = 0.02)]. CONCLUSION For postmenopausal women with higher femoral neck BMD appear to sustain more falls, but have a lower risk of severe fall injuries. Better TUG and single leg standing time predict lower risk of falls and fall injuries.
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Exercise-induced improvement of glycemic fluctuation and its relationship with fat and muscle distribution in type 2 diabetes.
Liu, D, Zhang, Y, Wu, Q, Han, R, Cheng, D, Wu, L, Guo, J, Yu, X, Ge, W, Ni, J, et al
Journal of diabetes. 2024;16(4):e13549
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Exercise plays a crucial role in managing type 2 diabetes (T2DM). However, the impact of exercise on blood glucose fluctuation and its relationship with body fat and muscle distribution remains an area of interest. The aim of this study was to investigate the effect of combined aerobic and resistance exercise training on blood glucose fluctuation in type 2 diabetes patients and explore the predictors of exercise-induced glycaemic response. This study was a two-arm randomised controlled trial with an exercise group and a control group. The study included 50 patients with T2DM. Results showed that: - exercise training led to decreased 24-hour blood glucose fluctuations in the exercise group. - baseline visceral fat area and mid-thigh muscle area were significant predictors of glycaemic variability changes. Authors concluded that acute combined aerobic and resistance exercise training could improve glycemic fluctuation in T2D patients, and baseline fat and muscle distribution play a role in this effect.
Abstract
AIMS: Management of blood glucose fluctuation is essential for diabetes. Exercise is a key therapeutic strategy for diabetes patients, although little is known about determinants of glycemic response to exercise training. We aimed to investigate the effect of combined aerobic and resistance exercise training on blood glucose fluctuation in type 2 diabetes patients and explore the predictors of exercise-induced glycemic response. MATERIALS AND METHODS Fifty sedentary diabetes patients were randomly assigned to control or exercise group. Participants in the control group maintained sedentary lifestyle for 2 weeks, and those in the exercise group specifically performed combined exercise training for 1 week. All participants received dietary guidance based on a recommended diet chart. Glycemic fluctuation was measured by flash continuous glucose monitoring. Baseline fat and muscle distribution were accurately quantified through magnetic resonance imaging (MRI). RESULTS Combined exercise training decreased SD of sensor glucose (SDSG, exercise-pre vs exercise-post, mean 1.35 vs 1.10 mmol/L, p = .006) and coefficient of variation (CV, mean 20.25 vs 17.20%, p = .027). No significant change was observed in the control group. Stepwise multiple linear regression showed that baseline MRI-quantified fat and muscle distribution, including visceral fat area (β = -0.761, p = .001) and mid-thigh muscle area (β = 0.450, p = .027), were significantly independent predictors of SDSG change in the exercise group, as well as CV change. CONCLUSIONS Combined exercise training improved blood glucose fluctuation in diabetes patients. Baseline fat and muscle distribution were significant factors that influence glycemic response to exercise, providing new insights into personalized exercise intervention for diabetes.
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Changes in bone density and microarchitecture following treatment of Graves' disease and the effects of vitamin D supplementation. A randomized clinical trial.
Grove-Laugesen, D, Ebbehoj, E, Watt, T, Hansen, KW, Rejnmark, L
Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA. 2024;35(12):2153-2164
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Graves' disease, an autoimmune disorder leading to hyperthyroidism, can significantly impact bone health, resulting in decreased bone density and altered bone microarchitecture. The aim of this study was to evaluate changes in bone density and microarchitecture following treatment for Graves' disease and to assess the additional effects of vitamin D supplementation. This research is a randomised clinical trial involving patients diagnosed with Graves' disease, who were divided into groups receiving standard treatment with or without vitamin D supplementation. Results showed that 9 months supplementation with a daily dose of 70 µg vitamin D3 did not improve areal or volumetric bone mineral density (BMD), bone microarchitecture or estimated bone strength in a population with an adequate dietary calcium intake. The only significant effect of vitamin D was a smaller increase in PTH level compared to placebo, whereas there was no impact on bone turnover markers. Authors concluded that 9 months of high dose vitamin D3 supplementation does not offer benefit by improving skeletal health.
Abstract
UNLABELLED Thyrotoxicosis leads to loss of bone mass. Vitamin D is important to bone health. In this randomized, placebo-controlled trial, we showed that bone restoration did not improve when adding vitamin D supplementation to standard care of Graves' disease thyrotoxicosis. Bone density and microarchitecture improved markedly with treatment of thyrotoxicosis. PURPOSE Vitamin D is important to skeletal health and ensuring a replete vitamin D status is recommended. In thyrotoxicosis, bone turnover is increased and bone mass density (BMD) reduced. We examined whether vitamin D supplementation improves bone recovery in thyrotoxicosis caused by Graves' disease (GD). METHODS Using a double-blinded design, hyperthyroid patients with GD were randomized to vitamin D3 70 µg/day (2800 IU) or similar placebo as add-on to antithyroid drugs (ATD). At baseline and 9 months, we measured BMD and bone architecture using DXA and high resolution peripheral quantitative computerized tomography. Bone turnover markers (BTM) were measured at 3 months also. Effect of vitamin D versus placebo and the response to ATD treatment were analyzed using linear mixed modelling. RESULTS Eighty-six GD patients were included (age 41 ± 14 years, 86% females). Compared to placebo, vitamin D3 did not improve BMD or microarchitecture. In response to ATD, BMD increased in the hip by 2% (95%CI: 1-4%). Cortical porosity decreased in tibia (- 7% [95%CI: - 12 to - 2%]) and radius [- 14% [95%CI: - 24 to - 3%]), and trabecular thickness increased (tibia (5% [95%CI: 2 - 9%]) and radius (4% [95%CI: 1-7%]). Changes in BTM, but not thyroid hormones, were associated with changes in BMD by DXA and with changes in the cortical compartment. CONCLUSION In newly diagnosed GD, 9 months of high dose vitamin D3 supplementation does not offer benefit by improving skeletal health. Treatment of thyrotoxicosis is associated with the recovery of BMD and microarchitecture. GOV IDENTIFIER NCT02384668.
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Effects of a Cycling versus Running HIIT Program on Fat Mass Loss and Gut Microbiota Composition in Men with Overweight/Obesity.
Couvert, A, Goumy, L, Maillard, F, Esbrat, A, Lanchais, K, Saugrain, C, Verdier, C, Doré, E, Chevarin, C, Adjtoutah, D, et al
Medicine and science in sports and exercise. 2024;56(5):839-850
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Excess fat mass (FM) and metabolic disturbances are associated with higher prevalence of cardiovascular diseases (CVD), type 2 diabetes and many cancer types. Regular exercise decreases FM and simultaneously increases the cardiorespiratory capacity and preserves the lean mass. The study aimed to compare the effects of two 12-week high-intensity interval training (HIIT) programmes (cycling vs. running) on body composition and faecal microbiota composition in men with overweight or obesity. This study was a randomised controlled trial involving non-dieting men. Twenty participants were randomly divided into the two exercise groups: HIIT-RUN (n = 10) and HIIT-BIKE (n = 10). Results showed that both cycling and running HIIT programmes improved body composition in men with overweight/obesity. Additionally, baseline intestinal microbiota composition and its post-intervention variations were correlated with FM reduction, suggesting a possible link between these parameters. The authors concluded that both cycling and running HIIT programmes effectively reduced fat mass, and gut microbiota changes were associated with this improvement.
Abstract
PURPOSE High-intensity interval training (HIIT) can efficiently decrease total and (intra-)abdominal fat mass (FM); however, the effects of running versus cycling HIIT programs on FM reduction have not been compared yet. In addition, the link between HIIT-induced FM reduction and gut microbiota must be better investigated. The aim of this study was to compare the effects of two 12-wk HIIT isoenergetic programs (cycling vs running) on body composition and fecal microbiota composition in nondieting men with overweight or obesity. METHODS Sixteen men (age, 54.2 ± 9.6 yr; body mass index, 29.9 ± 2.3 kg·m -2 ) were randomly assigned to the HIIT-BIKE (10 × 45 s at 80%-85% of maximal heart rate, 90-s active recovery) or HIIT-RUN (9 × 45 s at 80%-85% of maximal heart rate, 90-s active recovery) group (3 times per week). Dual-energy x-ray absorptiometry was used to determine body composition. Preintervention and postintervention fecal microbiota composition was analyzed by 16S rRNA gene sequencing, and diet was controlled. RESULTS Overall, body weight, and abdominal and visceral FM decreased over time ( P < 0.05). No difference was observed for weight, total body FM, and visceral FM between groups (% change). Conversely, abdominal FM loss was greater in the HIIT-RUN group (-16.1% vs -8.3%; P = 0.050). The α-diversity of gut microbiota did not vary between baseline and intervention end and between groups, but was associated with abdominal FM change ( r = -0.6; P = 0.02). The baseline microbiota profile and composition changes were correlated with total and abdominal/visceral FM losses. CONCLUSIONS Both cycling and running isoenergetic HIIT programs improved body composition in men with overweight/obesity. Baseline intestinal microbiota composition and its postintervention variations were correlated with FM reduction, strengthening the possible link between these parameters. The mechanisms underlying the greater abdominal FM loss in the HIIT-RUN group require additional investigations.
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Health and performance effects of 12 weeks of small-sided street football training compared to grass football training in habitually active young men.
Randers, MB, Hagman, M, Christensen, JF, Póvoas, S, Nielsen, JJ, Krustrup, P
European journal of applied physiology. 2024;124(3):805-813
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Physical activity is essential in the prevention of non-communicable diseases. In recent years, many studies have shown that recreational team sports and especially football are very effective in improving participants’ health profile as these sports provide broad-spectrum training stimuli. The primary aim was to investigate the health and exercise performance effects of street football training on small pitches surrounded by boards, compared to small-sided football training on grass. This study was a randomised controlled trial involving 39 habitually active men. Participants were divided into three groups: a street football training group, a grass football training group, and an inactive control group. Results showed that 12 weeks of 1–2 weekly 60-min street football training sessions led to improved submaximal exercise capacity but had no significant effects on maximal oxygen uptake or other health-related or performance variables, despite a high heart-rate during the street football training sessions. Authors concluded that governing bodies of recreational football for health should be aware of how training is organised as this may well influence the health outcomes.
Abstract
PURPOSE The purpose of the present study was to investigate the health and exercise performance effects of street football training on very small pitches surrounded by boards in young habitually active men in comparison to small-sided football training on grass. METHODS Thirty-nine habitually active men (30.7 ± 6.7 years, 90.9 ± 16.6 kg, 183.8 ± 4.5 cm, 39.6 ± 6.0 mL/min/kg) were randomly assigned to a street football training group (ST) or grass football group (GR) playing small-sided games for 70 min, 1.5 and 1.7 times per week for 12 weeks, respectively, or an inactive control group (CO). Intensity during training was measured using heart rate (HR) and GPS units. Pre- and post-intervention, a test battery was completed. RESULTS Mean HR (87.1 ± 5.0 vs. 84.0 ± 5.3%HRmax; P > 0.05) and percentage of training time above 90%HRmax (44 ± 28 vs. 34 ± 24%; P > 0.05) were not different between ST and GR. VO2max increased (P < 0.001) by 3.6[95% CI 1.8;5.4]mL/min/kg in GR with no significant change in ST or CO. HR during running at 8 km/h decreased (P < 0.001) by 14[10;17]bpm in ST and by 12[6;19]bpm in GR, with no change in CO. No changes were observed in blood pressure, resting HR, total body mass, lean body mass, whole-body bone mineral density, fasting blood glucose, HbA1c, plasma insulin, total cholesterol(C), LDL-C or HDL-C. Moreover, no changes were observed in Yo-Yo IE2 performance, 30-m sprint time, jump length or postural balance. CONCLUSION Small-sided street football training for 12 weeks with 1-2 weekly sessions led to improvements in submaximal exercise capacity only, whereas recreational grass football training confirmed previous positive effects on submaximal exercise capacity as well as cardiorespiratory fitness.
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Effects of a Ketogenic Diet on Body Composition in Healthy, Young, Normal-Weight Women: A Randomized Controlled Feeding Trial.
Burén, J, Svensson, M, Liv, P, Sjödin, A
Nutrients. 2024;16(13)
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The ketogenic diet (KD) is a high-fat, low-carbohydrate diet that has gained popularity for its potential benefits in weight management and metabolic health. The aim of this study was to investigate the impact of a KD on body composition, including fat mass and lean body mass, in healthy, young, normal-weight women. This study was a randomised controlled feeding trial involving healthy, young, normal-weight women who were assigned to either a KD group or a control group following a standard diet for a specified period. Results showed: - that participants in the KD group experienced a significant reduction in fat mass compared to the control group. - that there was a preservation of lean body mass in the KD group, with no significant loss observed. - improvements in metabolic markers, such as insulin sensitivity and lipid profiles, were noted in the KD group. Authors concluded that a KD can effectively reduce fat mass while preserving lean body mass in healthy, young, normal-weight women. Thus, the findings of this study suggest that the ketogenic diet may be a viable option for body composition management in this population.
Expert Review
Conflicts of interest:
None
Take Home Message:
- The LCHF, ketogenic diet may be effective for weight loss in the short-term, however there may be a disproportionate loss of lean muscle in healthy, young women.
- As a result, it is unclear as to the long-term effects of the diet on metabolism and weight.
Evidence Category:
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A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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X
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
- The ketogenic diet has been extensively studied amongst individuals with chronic diseases but dietary studies of the effects of the ketogenic diet on young, healthy, normal weight women are lacking.
- This study aimed to determine the effects of a 4-week non-energy-restricted ketogenic, low carbohydrate and high fat diet (LCHF) on body composition in this group of individuals.
Methods
- This was an unblinded randomised control cross-over trial of 17 women comparing ketogenic diet with control.
- The study ran for 4 weeks with a 15 week washout period between treatment cross-over.
- Body composition was measured using dual-energy x-ray absorptiometry.
- Women were aged 18-30 years with a body mass index of 18.5-25 kg/m-2.
- Ketogenic diets consisted of 19% daily energy intake from protein, 4% carbohydrates, and 77% fat (33% saturated fat).
- Control diet consisted of 44% carbohydrates, 33% fat and 19% protein.
- No supplements or sweeteners were consumed during the study.
- Physical activity remained constant amongst the treatment periods.
Results
- Compared to control, LCHF, ketogenic diet decreased total fat mass (−0.66 kg, 95% confidence interval (CI): [−1.00, −0.32], p < 0.001), total lean mass (−1.45 kg, 95% confidence interval (CI): [−1.90, −1.00], p < 0.001), and appendicular lean mass (−0.60 kg, 95% confidence interval (CI): [−0.78, −0.42], p < 0.001).
Conclusion
- It was concluded that LCHF, ketogenic diet is effective for weight loss in healthy, young women.
- However, there was a disproportionate loss of lean muscle mass to fat mass.
Clinical practice applications:
- Healthy, young women who are trying to lose weight may find a LCHF, ketogenic effective for weight loss.
- However clinical practitioners and Nutritional therapists may like to undertake further research on ways to limit lean muscle loss when undergoing a LCHF, ketogenic diet.
Considerations for future research:
- Future research may like to consider adding a trial arm where women undergo resistance, strength training to see effects on lean muscle.
Abstract
This study investigates the effects of a ketogenic low-carbohydrate high-fat (LCHF) diet on body composition in healthy, young, normal-weight women. With the increasing interest in ketogenic diets for their various health benefits, this research aims to understand their impact on body composition, focusing on women who are often underrepresented in such studies. Conducting a randomized controlled feeding trial with a crossover design, this study compares a ketogenic LCHF diet to a Swedish National Food Agency (NFA)-recommended control diet over four weeks. Seventeen healthy, young, normal-weight women adhered strictly to the provided diets, with ketosis confirmed through blood β-hydroxybutyrate concentrations. Dual-energy X-ray absorptiometry (DXA) was utilized for precise body composition measurements. To avoid bias, all statistical analyses were performed blind. The findings reveal that the ketogenic LCHF diet led to a significant reduction in both lean mass (-1.45 kg 95% CI: [-1.90;-1.00]; p < 0.001) and fat mass (-0.66 kg 95% CI: [-1.00;-0.32]; p < 0.001) compared to the control diet, despite similar energy intake and physical activity levels. This study concludes that while the ketogenic LCHF diet is effective for weight loss, it disproportionately reduces lean mass over fat mass, suggesting the need for concurrent strength training to mitigate muscle loss in women following this diet.
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Intermittent fasting, calorie restriction, and a ketogenic diet improve mitochondrial function by reducing lipopolysaccharide signaling in monocytes during obesity: A randomized clinical trial.
Guevara-Cruz, M, Hernández-Gómez, KG, Condado-Huerta, C, González-Salazar, LE, Peña-Flores, AK, Pichardo-Ontiveros, E, Serralde-Zúñiga, AE, Sánchez-Tapia, M, Maya, O, Medina-Vera, I, et al
Clinical nutrition (Edinburgh, Scotland). 2024;43(8):1914-1928
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Plain language summary
Mitochondria are the main generators of energy in cells. Dysfunction of mitochondria has been seen in people with chronic diseases and this may be due to an increase in inflammation controlled by the gut microbiota. Several dietary strategies have been thought to aid mitochondrial function including intermittent fasting (IF), ketogenic diet (KD), and calorie restriction (CR). This randomised control trial of 44 individuals with obesity aimed to determine the effects of IF (16:8 pattern), KD (15-25% protein, 5-10% carbohydrate, 70-80% fat), and CR (25-35% protein, 45-55% carbohydrates, 20-30% fat) on mitochondrial function in cells responsible for inflammation and on gut microbiota. The results showed that after one month IF, KD, and CR improved mitochondrial function and energy production, decreased body weight and belly fat and increased gut microbiota diversity and changed several different species. Gut microbiota were shown to be modulating the alterations in mitochondrial function through the generation of inflammatory molecules. It was concluded that changes in diet altered the gut microbiota, which had favourable effects on inflammation and mitochondrial function. This study could be used by healthcare professionals to understand that in the short term IF, CR, and KD can help weight loss in individuals with obesity and this may be due to favourable effects on the gut microbiota.
Abstract
BACKGROUND Mitochondrial dysfunction occurs in monocytes during obesity and contributes to a low-grade inflammatory state; therefore, maintaining good mitochondrial conditions is a key aspect of maintaining health. Dietary interventions are primary strategies for treating obesity, but little is known about their impact on monocyte bioenergetics. Thus, the aim of this study was to evaluate the effects of calorie restriction (CR), intermittent fasting (IF), a ketogenic diet (KD), and an ad libitum habitual diet (AL) on mitochondrial function in monocytes and its modulation by the gut microbiota. METHODS AND FINDINGS A randomized controlled clinical trial was conducted in which individuals with obesity were assigned to one of the 4 groups for 1 month. Subsequently, the subjects received rifaximin and continued with the assigned diet for another month. The oxygen consumption rate (OCR) was evaluated in isolated monocytes, as was the gut microbiota composition in feces and anthropometric and biochemical parameters. Forty-four subjects completed the study, and those who underwent CR, IF and KD interventions had an increase in the maximal respiration OCR (p = 0.025, n2p = 0.159 [0.05, 0.27] 95% confidence interval) in monocytes compared to that in the AL group. The improvement in mitochondrial function was associated with a decrease in monocyte dependence on glycolysis after the IF and KD interventions. Together, diet and rifaximin increased the gut microbiota diversity in the IF and KD groups (p = 0.0001), enriched the abundance of Phascolarctobacterium faecium (p = 0.019) in the CR group and Ruminococcus bromii (p = 0.020) in the CR and KD groups, and reduced the abundance of lipopolysaccharide (LPS)-producing bacteria after CR, IF and KD interventions compared to the AL group at the end of the study according to ANCOVA with covariate adjustment. Spearman's correlation between the variables measured highlighted LPS as a potential modulator of the observed effects. In line with this findings, serum LPS and intracellular signaling in monocytes decreased with the three interventions (CR, p = 0.002; IF, p = 0.001; and KD, p = 0.001) compared to those in the AL group at the end of the study. CONCLUSIONS We conclude that these dietary interventions positively regulate mitochondrial bioenergetic health and improve the metabolic profile of monocytes in individuals with obesity via modulation of the gut microbiota. Moreover, the evaluation of mitochondrial function in monocytes could be used as an indicator of metabolic and inflammatory status, with potential applications in future clinical trials. TRIAL REGISTRATION This trial was registered with ClinicalTrials.gov (NCT05200468).