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Effects of lifestyle interventions on cardiovascular risk factors in South Asians: a systematic review and meta-analysis.
Limbachia, J, Ajmeri, M, Keating, BJ, de Souza, RJ, Anand, SS
BMJ open. 2022;12(12):e059666
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The prevalence of cardiovascular disease (CVD) and associated mortality risk is high in the South Asian population in western countries. Regular physical activity and a healthy diet may modify the risk factors of CVD, such as abdominal fat, high cholesterol, and blood sugar irregularities. This systematic review and meta-analysis included thirty-five randomised controlled trials to evaluate the effectiveness of diet, physical activity interventions or a combination of diet and physical activity interventions on CVD risk factors and compared it against usual care. Combining diet and physical activity interventions reduced CVD risk factors such as systolic and diastolic blood pressure, BMI, weight, waist circumference and fasting plasma glucose (FPG). Dietary interventions reduced diastolic blood pressure, triglycerides, low-density lipoprotein cholesterol, BMI, weight and FPG. Physical activity modifications improved diastolic and systolic blood pressure and high-density lipoprotein cholesterol. Healthcare professionals can use the study results to understand how tailored diet and physical activity modifications improve the CVD risk factors in South Asians. However, further robust studies are required as most of these evidences were of moderate quality and lacked clinical significance.
Abstract
BACKGROUND The cardiovascular disease (CVD) burden among South Asians is high. Lifestyle interventions have been effective in the primary prevention of CVD, but this has not been replicated, through a synthesis of randomised trials, in South Asians. METHODS Four electronic databases (MEDLINE, Embase, CENTRAL and CINAHL), two clinical trial registries and references of included articles were searched through June 2022 (featuring ≥90% South Asian participants). Random-effects pairwise meta-analyses were performed, and heterogeneity was quantified with the I2 statistic. The Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) framework was used to report on the quality of evidence (International Prospective Register of Systematic Reviews registration (PROSPERO). RESULTS Thirty-five studies were included. Twelve tested diet and physical activity interventions; 18 tested diet alone; and 5 tested physical activity alone. All reported effects of the intervention(s) on at least one established risk factor for CVD, including blood pressure (systolic blood pressure (SBP), diastolic blood pressure (DBP) and blood lipids (high-density lipoprotein cholesterol (HDLc), low-density lipoprotein cholesterol (LDLc) or triglycerides). No trials reported clinical CVD. There is moderate-quality evidence that diet and physical activity interventions improve SBP (mean difference (MD) -2.72 mm Hg, 95% CI -4.11 to -1.33) and DBP (MD -1.53 mm Hg, 95% CI -2.57 to -0.48); high-quality to moderate-quality evidence that diet-only interventions improve DBP (MD -2.05 mm Hg, 95% CI -2.93 to -1.16) and blood lipids (triglycerides (MD -0.10 mmol/L, 95% CI -0.14 to -0.06) and LDLc (MD -0.19 mmol/L, 95% CI -0.32 to -0.06)); and moderate-quality evidence that physical activity-only interventions improve SBP (MD -9.7 mm Hg, 95% CI -11.05 to -8.35), DBP (MD -7.29 mm Hg, 95% CI -8.42 to -6.16) and HDLc (MD 0.08 mmol/L, 95% CI 0.04 to 0.11) compared with usual care. CONCLUSIONS Lifestyle interventions improve blood pressure and blood lipid profiles in adult South Asians at risk of CVD. Tailored interventions should be used to modify cardiovascular risk factors in this at-risk group. PROSPERO REGISTRATION NUMBER CRD42018090419.
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Effects of curcumin and/or coenzyme Q10 supplementation on metabolic control in subjects with metabolic syndrome: a randomized clinical trial.
Sangouni, AA, Taghdir, M, Mirahmadi, J, Sepandi, M, Parastouei, K
Nutrition journal. 2022;21(1):62
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Metabolic syndrome (MetS) is a cluster of metabolic disorders such as hyperlipidaemia, hypertension, hyperglycaemia, insulin resistance, and abdominal obesity. MetS is associated with cardiovascular disease (CVD), type 2 diabetes mellitus and non-alcoholic fatty liver disease. The aim of this study was to investigate the effects of curcumin and/or coenzyme Q10 supplementation on metabolic syndrome components in subjects with MetS. This study is a 2×2 factorial, randomised, double-blinded, placebo-controlled study which was conducted for 12 weeks. Eighty-eight subjects were randomly assigned into four groups. All subjects completed the trial. Results show that curcumin supplementation improves lipid profile, but it does not have any effect on body composition, hypertension and fasting plasma glucose. However, supplementation with coenzyme Q10 as well as curcumin plus coenzyme Q10 did not show any significant effects on lipid profile, body composition, hypertension and fasting plasma glucose. Authors conclude that curcumin supplementation (especially by its effects on dyslipidaemia) is more effective than coenzyme Q10 as well as the combination of curcumin and coenzyme Q10 in the management of MetS. However, curcumin, coenzyme Q10 and their combination have no effect on body composition, hypertension and glycaemic control.
Abstract
BACKGROUND Metabolic syndrome (MetS) as a cluster of conditions including hyperlipidemia, hypertension, hyperglycemia, insulin resistance, and abdominal obesity is linked to cardiovascular diseases and type 2 diabetes. Evidence suggested that intake of curcumin and coenzyme Q10 may have therapeutic effects in the management of MetS. AIMS We investigated the effects of curcumin and/or coenzyme Q10 supplementation on metabolic syndrome components including systolic blood pressure (SBP), diastolic blood pressure (DBP), waist circumference (WC), triglyceride (TG), high density lipoprotein-cholesterol (HDL-c) and fasting plasma glucose (FPG) as primary outcomes, and total cholesterol (TC), low density lipoprotein-cholesterol (LDL-c) and body mass index (BMI) as secondary outcomes in subjects with MetS. METHODS In this 2 × 2 factorial, randomized, double-blinded, placebo-controlled study, 88 subjects with MetS were randomly assigned into four groups including curcumin plus placebo (CP), or coenzyme Q10 plus placebo (QP), or curcumin plus coenzyme Q10 (CQ), or double placebo (DP) for 12 weeks. RESULTS The CP group compared with the three other groups showed a significant reduction in HDL-c (P = 0.001), TG (P < 0.001), TC (P < 0.001), and LDL-c (P < 0.001). No significant differences were seen between the four groups in terms of SBP, DBP, FPG, WC, BMI and weight. CONCLUSION Curcumin improved dyslipidemia, but had no effect on body composition, hypertension and glycemic control. Furthermore, coenzyme Q10 as well as the combination of curcumin and coenzyme Q10 showed no therapeutic effects in subjects with MetS. The trial was registered on 09/21/2018 at the Iranian clinical trials website (IRCT20180201038585N2), URL: https://www.irct.ir/trial/32518 .
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The effects of the Green-Mediterranean diet on cardiometabolic health are linked to gut microbiome modifications: a randomized controlled trial.
Rinott, E, Meir, AY, Tsaban, G, Zelicha, H, Kaplan, A, Knights, D, Tuohy, K, Scholz, MU, Koren, O, Stampfer, MJ, et al
Genome medicine. 2022;14(1):29
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The Mediterranean (MED) diet, high in nuts, vegetables, and legumes and low in red meat intake, is recommended for the prevention of cardiometabolic diseases. It has been reported that adherence to MED dietary patterns is associated with a distinct gut microbiome profile. The main aim of this study was to investigate the effect of MED-based dietary interventions on the gut microbiome composition and function. This study was focused on the analysis of the DIRECT-PLUS trials’ secondary outcomes, including gut microbiome profile, lipid profile, glycaemic control, inflammatory state, and cardiometabolic risk. All eligible participants were randomised in a 1:1:1 ratio, into one of the three intervention groups: healthy dietary guidelines (HDG), MED, and Green-MED, all combined with physical activity accommodation. Results showed that: - the Green-MED diet [an improved version of the healthy MED diet, with increased consumption of plant-based foods and reduced meat intake] induced a prominent change in the gut microbiome composition, driven by the low-prevalent “non-core” fraction of the gut microbiome. - the MED and Green-MED diets improved cardiometabolic markers. These beneficial changes in levels of cardiometabolic biomarkers were associated with a concurrent shift in the gut microbiome composition. Authors conclude that the Green-MED diet has extensive effects on the composition and function of the host gut microbiome, with the latter partially mediating the beneficial effects of the diet on cardiometabolic health.
Abstract
BACKGROUND Previous studies have linked the Mediterranean diet (MED) with improved cardiometabolic health, showing preliminary evidence for a mediating role of the gut microbiome. We recently suggested the Green-Mediterranean (Green-MED) diet as an improved version of the healthy MED diet, with increased consumption of plant-based foods and reduced meat intake. Here, we investigated the effects of MED interventions on the gut microbiota and cardiometabolic markers, and the interplay between the two, during the initial weight loss phase of the DIRECT-PLUS trial. METHODS In the DIRECT-PLUS study, 294 participants with abdominal obesity/dyslipidemia were prospectively randomized to one of three intervention groups: healthy dietary guidelines (standard science-based nutritional counseling), MED, and Green-MED. Both isocaloric MED and Green-MED groups were supplemented with 28g/day walnuts. The Green-MED group was further provided with daily polyphenol-rich green tea and Mankai aquatic plant (new plant introduced to a western population). Gut microbiota was profiled by 16S rRNA for all stool samples and shotgun sequencing for a select subset of samples. RESULTS Both MED diets induced substantial changes in the community structure of the gut microbiome, with the Green-MED diet leading to more prominent compositional changes, largely driven by the low abundant, "non-core," microorganisms. The Green-MED diet was associated with specific microbial changes, including enrichments in the genus Prevotella and enzymatic functions involved in branched-chain amino acid degradation, and reductions in the genus Bifidobacterium and enzymatic functions responsible for branched-chain amino acid biosynthesis. The MED and Green-MED diets were also associated with stepwise beneficial changes in body weight and cardiometabolic biomarkers, concomitantly with the increased plant intake and reduced meat intake. Furthermore, while the level of adherence to the Green-MED diet and its specific green dietary components was associated with the magnitude of changes in microbiome composition, changes in gut microbial features appeared to mediate the association between adherence to the Green-MED and body weight and cardiometabolic risk reduction. CONCLUSIONS Our findings support a mediating role of the gut microbiome in the beneficial effects of the Green-MED diet enriched with Mankai and green tea on cardiometabolic risk factors. TRIAL REGISTRATION The study was registered on ClinicalTrial.gov ( NCT03020186 ) on January 13, 2017.
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A randomized controlled trial for response of microbiome network to exercise and diet intervention in patients with nonalcoholic fatty liver disease.
Cheng, R, Wang, L, Le, S, Yang, Y, Zhao, C, Zhang, X, Yang, X, Xu, T, Xu, L, Wiklund, P, et al
Nature communications. 2022;13(1):2555
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Non-alcoholic fatty liver disease (NAFLD) is a common chronic disease that is associated with the development of type 2 diabetes (T2D). A commonality between the two diseases is the body’s inefficiency to uptake sugar from the blood, known as insulin resistance. Dysbiosis of the gut microbiota has been shown to be involved in NAFLD and T2D. Exercise and dietary modifications have been shown to increase gut microbiota diversity altering the composition, however the extent of this change is poorly understood. This randomised control trial of 115 individuals with NAFLD and insulin resistance aimed to determine the effects of aerobic exercise and a diet comprising of 37-40% carbohydrate, 35-37% fat, and 25-27% protein on gut microbiota diversity, liver fat content and sugar metabolism. The results showed that generally diet and exercise increased gut microbiota diversity and ensured maintenance of gut microbiota associated with healthy outcomes. Liver fat content was decreased the most with diet and exercise and by nearly 50% but not all subjects responded the same with responders and non-responders identified. It was concluded that there is a necessity for personalisation of diet and exercise programmes for the treatment of NAFLD. This study could be used by healthcare professionals to understand that gut microbiota diversity may be improved by diet and exercise, however not everyone may be similarly affected. Until more is understood about the gut microbiota, it may be necessary to try different diet and exercise regimes, which are optimal for each individual.
Abstract
Exercise and diet are treatments for nonalcoholic fatty liver disease (NAFLD) and prediabetes, however, how exercise and diet interventions impact gut microbiota in patients is incompletely understood. We previously reported a 8.6-month, four-arm (Aerobic exercise, n = 29; Diet, n = 28; Aerobic exercise + Diet, n = 29; No intervention, n = 29) randomized, singe blinded (for researchers), and controlled intervention in patients with NAFLD and prediabetes to assess the effect of interventions on the primary outcomes of liver fat content and glucose metabolism. Here we report the third primary outcome of the trial-gut microbiota composition-in participants who completed the trial (22 in Aerobic exercise, 22 in Diet, 23 in Aerobic exercise + Diet, 18 in No Intervention). We show that combined aerobic exercise and diet intervention are associated with diversified and stabilized keystone taxa, while exercise and diet interventions alone increase network connectivity and robustness between taxa. No adverse effects were observed with the interventions. In addition, in exploratory ad-hoc analyses we find that not all subjects responded to the intervention in a similar manner, when using differentially altered gut microbe amplicon sequence variants abundance to classify the responders and low/non-responders. A personalized gut microbial network at baseline could predict the individual responses in liver fat to exercise intervention. Our findings suggest an avenue for developing personalized intervention strategies for treatment of NAFLD based on host-gut microbiome ecosystem interactions, however, future studies with large sample size are needed to validate these discoveries. The Trial Registration Number is ISRCTN 42622771.
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Comparison of dietary and physical activity behaviors in women with and without polycystic ovary syndrome: a systematic review and meta-analysis of 39 471 women.
Kazemi, M, Kim, JY, Wan, C, Xiong, JD, Michalak, J, Xavier, IB, Ganga, K, Tay, CT, Grieger, JA, Parry, SA, et al
Human reproduction update. 2022;28(6):910-955
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Polycystic ovary syndrome (PCOS) is a heritable, prevalent and complex endocrine disorder. Besides reproductive manifestations of increased risk of infertility and pregnancy complications, women with PCOS often exhibit cardio-metabolic aberrations and are at risk for developing metabolic syndrome, type 2 diabetes and sleep disturbance. The aim of this study was to test the hypothesis that reproductive-aged women with PCOS would exhibit worse dietary and physical activity (PA) behaviours versus their counterparts without PCOS. This study was a systematic review and meta-analysis of 54 studies (61 publications). The studies included a total of 39,471 participants and 116 experimental arms (n = 8736 PCOS [59 arms]). Results showed that women with PCOS exhibit an overall adverse lifestyle behaviour, specifically poorer dietary intakes (lower diet quality, higher cholesterol, lower magnesium, tendency for lower zinc), and lower total PA compared to those without PCOS, despite lower alcohol intakes. Furthermore, compared to women without PCOS, the women with PCOS consumed worse or similar consumption of core food groups (grains, fruits, vegetables, proteins, seeds, nuts, dairy). Authors conclude that providing education on lifestyle modification is crucial for women with PCOS to improve their short- and long-term reproductive, metabolic, and psychological health.
Abstract
BACKGROUND Lifestyle (dietary and/or physical activity [PA]) modification is recommended as first-line therapy to manage polycystic ovary syndrome (PCOS). Current recommendations are based on healthy lifestyle practices for the general public since evidence for unique lifestyle approaches in PCOS is limited and low quality. OBJECTIVE AND RATIONALE We aimed to synthesize evidence on dietary and PA behaviors between women with PCOS and those without PCOS. Primary outcomes were overall diet quality, total energy intake and total PA, and secondary outcomes included macronutrients, micronutrients, food groups, foods, glycemic indices, sedentary time and sitting levels. We conducted this work to identify any unique lifestyle behaviors in women with PCOS that could underlie the propensity of weight gain and obesity in PCOS and be targeted for precision nutrition and PA interventions. These findings could be used to inform future practice recommendations and research that more effectively address complications (weight gain, obesity, diabetes, infertility, cardiovascular disease and mental health) in this high-risk population. SEARCH METHODS Databases of MEDLINE, Web of Science, Scopus and CINAHL were searched until 15 February 2022 to identify observational studies documenting dietary and PA behaviors between women with PCOS and without PCOS (Controls). Studies on children, adolescents (<18 years), pregnant or menopausal-aged women (>50 years) were excluded. Data were pooled by random-effects models and expressed as (standardized) mean differences (MD) and 95% CIs. The risk of bias was assessed by the Newcastle-Ottawa scale (NOS). OUTCOMES Fifty-four studies (N = 39 471 participants; [n = 8736 PCOS; 30 735 Controls]) were eligible (96%; [52/54] NOS scores ≥ 7). Women with PCOS had higher cholesterol (MD: 12.78, 95% CI: 1.48 to 24.08 mg/day; P = 0.03; I2 = 19%), lower magnesium (MD: -21.46, 95% CI: -41.03 to -1.91 mg/day; P = 0.03; I2 = 76%), and a tendency for lower zinc (MD: -1.08, 95% CI: -2.19 to -0.03 mg/day; P = 0.05; I2 = 96%) intake, despite lower alcohol consumption (MD: -0.95, 95% CI: -1.67 to 0.22 g/day; P = 0.02; I2 = 0%) versus Controls. Also, women with PCOS had lower total PA (standardized mean difference: -0.38, 95% CI: -0.72 to 0.03; P = 0.03; I2 = 98%). Conversely, energy, macronutrients (carbohydrate, fat, protein, fiber), micronutrients (folic acid, iron, calcium, sodium), glycemic index and glycemic load were similar (all: P ≥ 0.06). Most eligible studies reported lower total adherence to healthy eating patterns or poorer consumption of major food groups (grains, fruits, vegetables, proteins, seeds, nuts, dairy) in women with PCOS, as described narratively since variable study methodology did not permit meta-analyses. WIDER IMPLICATIONS Collective evidence supports that women with PCOS have a lower overall diet quality, poorer dietary intakes (higher cholesterol, lower magnesium and zinc) and lower total PA, despite lower alcohol consumption versus those without PCOS. Considerable heterogeneity among studies reinforces the need for research to address any relative contributions of other factors (e.g. genetic, metabolic or sociodemographic) to the observed differences. These clarifications may contribute to future evidence-based guideline recommendations on monitoring and managing PCOS in the era of precision lifestyle medicine.
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Consuming a Protein and Fiber-Based Supplement Preload Promotes Weight Loss and Alters Metabolic Markers in Overweight Adults in a 12-Week, Randomized, Double-Blind, Placebo-Controlled Trial.
Glynn, EL, Fleming, SA, Edwards, CG, Wilson, MJ, Evans, M, Leidy, HJ
The Journal of nutrition. 2022;152(6):1415-1425
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One of the challenges of reduced-calorie diets is the inability to control appetite. Reductions in food intake can lead to the activation of neurological pathways that increase hunger and food cravings. Adjusting nutrient intake has the potential to serve as an effective strategy for increasing feelings of satiety, which can lead to improved appetite control. The aim of this study was to determine if greater weight loss and greater changes in body composition and metabolic outcomes could be achieved following a 12-wk energy-restricted diet that included twice-daily consumption of a protein and fibre-based multi-ingredient nutritional supplement shake (HPF) compared with an isocaloric low-protein/lower-fibre placebo (LPF) in adults with overweight and obesity. This study is a double-blind randomised placebo-controlled study. Two hundred and six healthy adults were recruited and randomly assigned to intervention groups in a 1:1 ratio. Results show that the habitual consumption of an HPF preload 30 min before breakfast and lunch resulted in greater weight loss compared with an isocaloric LPF preload in overweight/obese adults. In addition, improved metabolic outcomes were observed in the HPF group throughout the 84-d randomized controlled trial. Authors conclude that diet composition rather than energy reduction alone may influence the success of a weight-loss regimen, potentially including protein and fibre content.
Abstract
BACKGROUND Higher protein and fiber diets promote weight management and metabolic health. OBJECTIVES This study aimed to determine if greater weight loss and positive changes in metabolic outcomes could be achieved with twice-daily consumption of a high-protein and fiber-based multi-ingredient nutritional shake (HPF) compared with an isocaloric low-protein, lower fiber-based placebo (LPF). METHODS Study procedures were conducted by an independent research organization under clinicaltrials.gov registration NCT03057873. Healthy overweight and obese adults [n = 206; BMI (kg/m2): 27-35; 70% female] were randomly assigned to HPF or LPF. All participants were prescribed an energy-restricted diet (500 kcal/d less than energy needs) and consumed a HPF (17 g protein, 6 g fiber) or LPF (1 g protein, 3 g fiber) shake 30 min before breakfast and lunch for 12 wk. Primary outcomes included body weight and total body fat percentage. Blood samples were collected at days (D) 0, 28, 56, and 84 for secondary analyses related to metabolic markers of health. RESULTS Although weight loss occurred in both groups, HPF had greater weight loss at D84 compared with LPF (-3.3 kg vs. -1.8 kg, P < 0.05). Percentage body fat decreased in both groups (HPF: -1.33%, LPF: -1.09%; P < 0.001) with no differences between groups. Serum total cholesterol, LDL cholesterol, and oxidized LDL decreased between -5.1% to -8.3%, whereas adiponectin increased over time in both groups; these changes occurred to a greater extent in HPF compared with LPF (all P < 0.05). CONCLUSIONS A multi-ingredient HPF nutritional supplement shake consumed as a preload before breakfast and lunch positively influenced weight management and metabolic outcomes in overweight adults compared with an LPF placebo. These findings suggest that specific nutrient factors (i.e., potentially including protein, fiber, and bioactive content) other than calorie reduction alone influence the success of a weight-loss regimen. This trial was registered at www.clinicaltrials.gov as NCT03057873.
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Time-restricted eating and exercise training improve HbA1c and body composition in women with overweight/obesity: A randomized controlled trial.
Haganes, KL, Silva, CP, Eyjólfsdóttir, SK, Steen, S, Grindberg, M, Lydersen, S, Hawley, JA, Moholdt, T
Cell metabolism. 2022;34(10):1457-1471.e4
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A healthy diet and regular physical activity are primary lifestyle strategies for the prevention and treatment of obesity and its associated conditions. However, poor adherence rates to these strategies limit their effectiveness. Time-restricted eating (TRE) is a popular dietary strategy that emphasises the timing of meals in alignment with diurnal circadian rhythms, permitting ad libitum energy intake during a restricted eating window (8–10 h between the first and last energy intake of the day). The aim of this study was to investigate the isolated and combined effects of TRE and high-intensity interval training (HIIT) on glycaemic control and cardiometabolic health outcomes in women with overweight/obesity. This study is a 7-week randomised controlled trial with four parallel groups: TRE (energy intake limited to a %10-h eating window every day), HIIT (three supervised treadmill exercise sessions per week), a combination (TREHIIT), and a control group (CON, no intervention). Participants (n=131) were randomly assigned to one of the four groups. . Results show that 7 weeks of TRE, HIIT, or a combination failed to improve glycaemic control in reproductive-aged women with overweight/obesity. However, the combination of TRE and HIIT significantly reduced glycated haemoglobin levels compared with CON and induced greater losses in body weight, fat mass, and visceral fat area compared with either intervention alone. Isolated TRE resulted in lower nocturnal glucose concentrations compared with CON. Authors conclude that combining TRE with HIIT can rapidly induce several health benefits and decrease metabolic disease risk in women with overweight/obesity. In fact, the high rates of compliance and adherence shown in their findings, highlight the potential of these diet-exercise (TRE and HIIT) protocols to be implemented in clinical practice for treatment and primary prevention of overweight/ obesity.
Abstract
Diet modification and exercise training are primary lifestyle strategies for obesity management, but poor adherence rates limit their effectiveness. Time-restricted eating (TRE) and high-intensity interval training (HIIT) improve cardiometabolic health in at-risk individuals, but whether these two interventions combined induce superior improvements in glycemic control than each individual intervention is not known. In this four-armed randomized controlled trial (ClinicalTrials.gov NCT04019860), we determined the isolated and combined effects of 7 weeks of TRE (≤10-h daily eating window, with ad libitum energy intake) and HIIT (three exercise sessions per week), compared with a non-intervention control group, on glycemic control and secondary cardiometabolic outcomes in 131 women (36.2 ± 6.2 years) with overweight/obesity. There were no statistically significant effects after isolated TRE, HIIT, or a combination (TREHIIT) on glucose area under the curve during an oral glucose tolerance test (the primary outcome) compared with the control group (TRE, -26.3 mmol/L; 95% confidence interval [CI], -82.3 to 29.7, p = 0.36; HIIT, -53.8 mmol/L; 95% CI, -109.2 to 1.6, p = 0.057; TREHIIT, -41.3 mmol/L; 95% CI, -96.4 to 13.8, p = 0.14). However, TREHIIT improved HbA1c and induced superior reductions in total and visceral fat mass compared with TRE and HIIT alone. High participant adherence rates suggest that TRE, HIIT, and a combination thereof may be realistic diet-exercise strategies for improving markers of metabolic health in women at risk of cardiometabolic disease.
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Precision Medicine Approach to Alzheimer's Disease: Successful Pilot Project.
Toups, K, Hathaway, A, Gordon, D, Chung, H, Raji, C, Boyd, A, Hill, BD, Hausman-Cohen, S, Attarha, M, Chwa, WJ, et al
Journal of Alzheimer's disease : JAD. 2022;88(4):1411-1421
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Neurodegenerative diseases such as Alzheimer’s disease are without effective therapeutics. The aim of this study was to compare the effects of a precision medicine approach to historical controls in patients with mild cognitive impairment or early dementia. This study is a proof-of-concept study which recruited twenty-five patients with Alzheimer’s disease or mild cognitive impairment, aged between 50–76 years. Patients were treated for nine months with a personalised, precision medicine protocol that addressed each patient’s identified potentially contributory factors. Results show that a precision medicine approach to the cognitive decline of Alzheimer’s disease and mild cognitive impairment may be an effective strategy, especially with continued optimization over time. Authors conclude that their findings indicate that it is possible to reverse cognitive decline in mild cognitive impairment and early dementia with a personalised, precision medicine (/systems medicine) protocol. This is a small study that requires larger scale initiatives, including examining the practicalities of integrating this approach into healthcare systems.
Abstract
BACKGROUND Effective therapeutics for Alzheimer's disease are needed. However, previous clinical trials have pre-determined a single treatment modality, such as a drug candidate or therapeutic procedure, which may be unrelated to the primary drivers of the neurodegenerative process. Therefore, increasing data set size to include the potential contributors to cognitive decline for each patient, and addressing the identified potential contributors, may represent a more effective strategy. OBJECTIVE To determine whether a precision medicine approach to Alzheimer's disease and mild cognitive impairment is effective enough in a proof-of-concept trial to warrant a larger, randomized, controlled clinical trial. METHODS Twenty-five patients with dementia or mild cognitive impairment, with Montreal Cognitive Assessment (MoCA) scores of 19 or higher, were evaluated for markers of inflammation, chronic infection, dysbiosis, insulin resistance, protein glycation, vascular disease, nocturnal hypoxemia, hormone insufficiency or dysregulation, nutrient deficiency, toxin or toxicant exposure, and other biochemical parameters associated with cognitive decline. Brain magnetic resonance imaging with volumetrics was performed at baseline and study conclusion. Patients were treated for nine months with a personalized, precision medicine protocol, and cognition was assessed at t = 0, 3, 6, and 9 months. RESULTS All outcome measures revealed improvement: statistically significant improvement in MoCA scores, CNS Vital Signs Neurocognitive Index, and Alzheimer's Questionnaire Change score were documented. No serious adverse events were recorded. MRI volumetrics also improved. CONCLUSION Based on the cognitive improvements observed in this study, a larger, randomized, controlled trial of the precision medicine therapeutic approach described herein is warranted.
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Effectiveness of a Smartphone App to Promote Healthy Weight Gain, Diet, and Physical Activity During Pregnancy (HealthyMoms): Randomized Controlled Trial.
Sandborg, J, Söderström, E, Henriksson, P, Bendtsen, M, Henström, M, Leppänen, MH, Maddison, R, Migueles, JH, Blomberg, M, Löf, M
JMIR mHealth and uHealth. 2021;9(3):e26091
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Excessive gestational weight gain (GWG) is associated with increased risk of caesarean delivery, gestational diabetes, pre-eclampsia, and obesity in both mother and child. In the last decade, the use of digital technologies (eg, mobile Health [mHealth]) to deliver lifestyle interventions has increased. The aim of this study was to investigate the effectiveness of the HealthyMoms app on GWG (primary outcome), body fatness, dietary habits (Swedish Healthy Eating Index), moderate-to-vigorous physical activity, glycaemia, and insulin resistance (secondary outcomes) in gestational week 37 among Swedish women. This study is a 2-arm parallel design randomised controlled trial. A total of 305 pregnant women were enrolled and randomised into either the intervention group or the control group. Participants in the intervention group, in addition to standard maternity care, received the HealthyMoms app which is a 6-month program aimed at promoting recommended GWG. Results did not show any statistically significant effect of the app on GWG; however, there was some evidence that women who were overweight or obese before pregnancy gained less weight in the intervention group as compared with the control group. Authors conclude that this intervention, solely delivered through an app, has potential to be useful for promoting a healthy lifestyle during pregnancy in many women while using less resources from health care.
Abstract
BACKGROUND Excessive gestational weight gain (GWG) during pregnancy is a major public health concern associated with negative health outcomes for both mother and child. Scalable interventions are needed, and digital interventions have the potential to reach many women and promote healthy GWG. Most previous studies of digital interventions have been small pilot studies or have not included women from all BMI categories. We therefore examined the effectiveness of a smartphone app in a large sample (n=305) covering all BMI categories. OBJECTIVE To investigate the effectiveness of a 6-month intervention (the HealthyMoms app) on GWG, body fatness, dietary habits, moderate-to-vigorous physical activity (MVPA), glycemia, and insulin resistance in comparison to standard maternity care. METHODS A 2-arm parallel randomized controlled trial was conducted. Women in early pregnancy at maternity clinics in Östergötland, Sweden, were recruited. Eligible women who provided written informed consent completed baseline measures, before being randomized in a 1:1 ratio to either an intervention (n=152) or control group (n=153). The control group received standard maternity care while the intervention group received the HealthyMoms smartphone app for 6 months (which includes multiple features, eg, information; push notifications; self-monitoring; and feedback features for GWG, diet, and physical activity) in addition to standard care. Outcome measures were assessed at Linköping University Hospital at baseline (mean 13.9 [SD 0.7] gestational weeks) and follow-up (mean 36.4 [SD 0.4] gestational weeks). The primary outcome was GWG and secondary outcomes were body fatness (Bod Pod), dietary habits (Swedish Healthy Eating Index) using the web-based 3-day dietary record Riksmaten FLEX, MVPA using the ActiGraph wGT3x-BT accelerometer, glycemia, and insulin resistance. RESULTS Overall, we found no statistically significant effect on GWG (P=.62); however, the data indicate that the effect of the intervention differed by pre-pregnancy BMI, as women with overweight and obesity before pregnancy gained less weight in the intervention group as compared with the control group in the imputed analyses (-1.33 kg; 95% CI -2.92 to 0.26; P=.10) and completers-only analyses (-1.67 kg; 95% CI -3.26 to -0.09; P=.031]). Bayesian analyses showed that there was a 99% probability of any intervention effect on GWG among women with overweight and obesity, and an 81% probability that this effect was over 1 kg. The intervention group had higher scores for the Swedish Healthy Eating Index at follow-up than the control group (0.27; 95% CI 0.05-0.50; P=.017). We observed no statistically significant differences in body fatness, MVPA, glycemia, and insulin resistance between the intervention and control group at follow up (P≥.21). CONCLUSIONS Although we found no overall effect on GWG, our results demonstrate the potential of a smartphone app (HealthyMoms) to promote healthy dietary behaviors as well as to decrease weight gain during pregnancy in women with overweight and obesity. TRIAL REGISTRATION ClinicalTrials.gov NCT03298555; https://clinicaltrials.gov/ct2/show/NCT03298555. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/13011.
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A 2 year physical activity and dietary intervention attenuates the increase in insulin resistance in a general population of children: the PANIC study.
Lakka, TA, Lintu, N, Väistö, J, Viitasalo, A, Sallinen, T, Haapala, EA, Tompuri, TT, Soininen, S, Karjalainen, P, Schnurr, TM, et al
Diabetologia. 2020;63(11):2270-2281
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The number of children and adolescents with type 2 diabetes and prediabetes has increased over the past decades which is likely due to decreased physical activity, increased sedentary time, unhealthy diet and consequently increased body fat content. Insulin resistance plays an important role in the development of type 2 diabetes. The aim of this 2 year non-randomised, controlled trial was to investigate the long-term effects of a combined physical activity and dietary intervention programme on insulin resistance in a general population of children, most of whom had a normal body weight. Children in the intervention group had six intervention visits which included 30–45 min of physical activity counselling and 30–45 min of dietary counselling for the children and their parents/carers. Fasting insulin and HOMA-IR (a measure for insulin resistance) increased significantly less in the intervention group than in the control group, whilst there were no significant differences in fasting glucose, body fat or lean body mass after 2 years. The effects on insulin resistance were mediated by changes in physical activity, sedentary time and diet. The authors conclude that the prevention of type 2 diabetes should begin in childhood by increasing physical activity, decreasing sedentary time and improving diet in the general paediatric population and not just among overweight and obese children.
Abstract
AIMS/HYPOTHESIS We studied for the first time the long-term effects of a combined physical activity and dietary intervention on insulin resistance and fasting plasma glucose in a general population of predominantly normal-weight children. METHODS We carried out a 2 year non-randomised controlled trial in a population sample of 504 children aged 6-9 years at baseline. The children were allocated to a combined physical activity and dietary intervention group (306 children at baseline, 261 children at 2-year follow-up) or a control group (198 children, 177 children) without blinding. We measured fasting insulin and fasting glucose, calculated HOMA-IR, assessed physical activity and sedentary time by combined heart rate and body movement monitoring, assessed dietary factors by a 4 day food record, used the Finnish Children Healthy Eating Index (FCHEI) as a measure of overall diet quality, and measured body fat percentage (BF%) and lean body mass by dual-energy x-ray absorptiometry. The intervention effects on insulin, glucose and HOMA-IR were analysed using the intention-to-treat principle and linear mixed-effects models after adjustment for sex, age at baseline, and pubertal status at baseline and 2 year follow-up. The measures of physical activity, sedentary time, diet and body composition at baseline and 2 year follow-up were entered one-by-one as covariates into the models to study whether changes in these variables might partly explain the observed intervention effects. RESULTS Compared with the control group, fasting insulin increased 4.65 pmol/l less (absolute change +8.96 vs +13.61 pmol/l) and HOMA-IR increased 0.18 units less (+0.31 vs +0.49 units) over 2 years in the combined physical activity and dietary intervention group. The intervention effects on fasting insulin (regression coefficient β for intervention effect -0.33 [95% CI -0.62, -0.04], p = 0.026) and HOMA-IR (β for intervention effect -0.084 [95% CI -0.156, -0.012], p = 0.023) were statistically significant after adjustment for sex, age at baseline, and pubertal status at baseline and 2 year follow-up. The intervention had no effect on fasting glucose, BF% or lean body mass. Changes in total physical activity energy expenditure, light physical activity, moderate-to-vigorous physical activity, total sedentary time, the reported consumption of high-fat (≥60%) vegetable oil-based spreads, and FCHEI, but not a change in BF% or lean body mass, partly explained the intervention effects on fasting insulin and HOMA-IR. CONCLUSIONS/INTERPRETATION The combined physical activity and dietary intervention attenuated the increase in insulin resistance over 2 years in a general population of predominantly normal-weight children. This beneficial effect was partly mediated by changes in physical activity, sedentary time and diet but not changes in body composition. TRIAL REGISTRATION ClinicalTrials.gov NCT01803776 Graphical abstract.