DHA supplementation during pregnancy does not reduce BMI or body fat mass in children: follow-up of the DHA to Optimize Mother Infant Outcome randomized controlled trial

Background Metabolic disorders are established precursors to cardiovascular diseases, yet they can be readily prevented with sustained lifestyle modifications. Objective We assessed the effectiveness of a smartphone-based weight management app on metabolic parameters in adults at high-risk, yet without physician diagnosis nor pharmacological treatment for metabolic syndrome, in a community setting. Methods In this 3-arm parallel-group, single-blind, randomized controlled trial, we recruited participants aged 30 to 59 years with at least 2 conditions defined by the Third Report of the National Cholesterol Education Program expert panel (abdominal obesity, high blood pressure, high triglycerides, low high-density lipoprotein cholesterol, and high fasting glucose level). Participants were randomly assigned (1:1:1) by block randomization to either the nonuser group (control), the app-based diet and exercise self-logging group (app only), or the app-based self-logging and personalized coaching from professional dieticians and exercise coordinators group (app with personalized coaching). Assessments were performed at baseline, week 6, week 12, and week 24. The primary outcome was change in systolic blood pressure (between baseline and follow-up assessments). Secondary outcomes were changes in diastolic blood pressure, body weight, body fat mass, waist circumference, homeostatic model of assessment of insulin resistance, triglyceride level, and high-density lipoprotein cholesterol level between baseline and follow-up assessments. Analysis was performed using intention-to-treat. Results Between October 28, 2017 and May 28, 2018, 160 participants participated in the baseline screening examination. Participants (129/160, 80.6%) who satisfied the eligibility criteria were assigned to control (n=41), app only (n=45), or app with personalized coaching (n=43) group. In each group, systolic blood pressure showed decreasing trends from baseline (control: mean –10.95, SD 2.09 mmHg; app only: mean –7.29, SD 1.83 mmHg; app with personalized coaching: mean –7.19, SD 1.66 mmHg), yet without significant difference among the groups (app only: P=.19; app with personalized coaching: P=.16). Instead, those in the app with personalized coaching group had greater body weight reductions (control: mean –0.12, SD 0.30 kg; app only: mean –0.35, SD 0.36 kg, P=.67; app with personalized coaching: mean –0.96, SD 0.37 kg; P=.08), specifically by body fat mass reduction (control: mean –0.13, SD 0.34 kg; app only: mean –0.64, SD 0.38 kg, P=.22; app with personalized coaching: mean –0.79, SD 0.38 kg; P=.08). Conclusions Simultaneous diet and exercise self-logging and persistent lifestyle modification coaching were ineffective in lowering systolic blood pressure but effective in losing weight and reducing body fat mass. These results warrant future implementation studies of similar models of care on a broader scale in the context of primary prevention. Trial Registration ClinicalTrials.gov NCT03300271; http://clinicaltrials.gov/ct2/show/NCT03300271

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Change in Body Fat Mass Is Independently Associated with Executive Functions in Older Women: A Secondary Analysis of a 12-Month Randomized Controlled Trial

PLoS ONE ◽

10.1371/journal.pone.0052831 ◽

2013 ◽

Vol 8 (1) ◽

pp. e52831 ◽

Cited By ~ 8

Author(s):

Elizabeth Dao ◽

Jennifer C. Davis ◽

Devika Sharma ◽

Alison Chan ◽

Lindsay S. Nagamatsu ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Executive Functions ◽

Older Women ◽

Body Fat ◽

Fat Mass ◽

Controlled Trial ◽

Secondary Analysis ◽

Body Fat Mass ◽

Randomized Controlled

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Effect of Smartphone-Based Lifestyle Coaching App on Community-Dwelling Population With Moderate Metabolic Abnormalities: Randomized Controlled Trial (Preprint)

10.2196/preprints.17435 ◽

2019 ◽

Author(s):

So Mi Jemma Cho ◽

Jung Hyun Lee ◽

Jee-Seon Shim ◽

Hyungseon Yeom ◽

Su Jin Lee ◽

...

Keyword(s):

Blood Pressure ◽

Systolic Blood Pressure ◽

Body Fat ◽

Fat Mass ◽

Controlled Trial ◽

Density Lipoprotein ◽

Body Fat Mass ◽

Randomized Controlled ◽

Diet And Exercise

BACKGROUND Metabolic disorders are established precursors to cardiovascular diseases, yet they can be readily prevented with sustained lifestyle modifications. OBJECTIVE We assessed the effectiveness of a smartphone-based weight management app on metabolic parameters in adults at high-risk, yet without physician diagnosis nor pharmacological treatment for metabolic syndrome, in a community setting. METHODS In this 3-arm parallel-group, single-blind, randomized controlled trial, we recruited participants aged 30 to 59 years with at least 2 conditions defined by the Third Report of the National Cholesterol Education Program expert panel (abdominal obesity, high blood pressure, high triglycerides, low high-density lipoprotein cholesterol, and high fasting glucose level). Participants were randomly assigned (1:1:1) by block randomization to either the nonuser group (control), the app-based diet and exercise self-logging group (app only), or the app-based self-logging and personalized coaching from professional dieticians and exercise coordinators group (app with personalized coaching). Assessments were performed at baseline, week 6, week 12, and week 24. The primary outcome was change in systolic blood pressure (between baseline and follow-up assessments). Secondary outcomes were changes in diastolic blood pressure, body weight, body fat mass, waist circumference, homeostatic model of assessment of insulin resistance, triglyceride level, and high-density lipoprotein cholesterol level between baseline and follow-up assessments. Analysis was performed using intention-to-treat. RESULTS Between October 28, 2017 and May 28, 2018, 160 participants participated in the baseline screening examination. Participants (129/160, 80.6%) who satisfied the eligibility criteria were assigned to control (n=41), app only (n=45), or app with personalized coaching (n=43) group. In each group, systolic blood pressure showed decreasing trends from baseline (control: mean –10.95, SD 2.09 mmHg; app only: mean –7.29, SD 1.83 mmHg; app with personalized coaching: mean –7.19, SD 1.66 mmHg), yet without significant difference among the groups (app only: P=.19; app with personalized coaching: P=.16). Instead, those in the app with personalized coaching group had greater body weight reductions (control: mean –0.12, SD 0.30 kg; app only: mean –0.35, SD 0.36 kg, P=.67; app with personalized coaching: mean –0.96, SD 0.37 kg; P=.08), specifically by body fat mass reduction (control: mean –0.13, SD 0.34 kg; app only: mean –0.64, SD 0.38 kg, P=.22; app with personalized coaching: mean –0.79, SD 0.38 kg; P=.08). CONCLUSIONS Simultaneous diet and exercise self-logging and persistent lifestyle modification coaching were ineffective in lowering systolic blood pressure but effective in losing weight and reducing body fat mass. These results warrant future implementation studies of similar models of care on a broader scale in the context of primary prevention. CLINICALTRIAL ClinicalTrials.gov NCT03300271; http://clinicaltrials.gov/ct2/show/NCT03300271

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A randomized controlled trial to isolate the effects of fasting and energy restriction on weight loss and metabolic health in lean adults

Science Translational Medicine ◽

10.1126/scitranslmed.abd8034 ◽

2021 ◽

Vol 13 (598) ◽

pp. eabd8034

Author(s):

Iain Templeman ◽

Harry Alex Smith ◽

Enhad Chowdhury ◽

Yung-Chih Chen ◽

Harriet Carroll ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Energy Balance ◽

Energy Intake ◽

Body Mass ◽

Body Fat ◽

Fat Mass ◽

Controlled Trial ◽

Energy Restriction ◽

Randomized Controlled ◽

Daily Energy

Intermittent fasting may impart metabolic benefits independent of energy balance by initiating fasting-mediated mechanisms. This randomized controlled trial examined 24-hour fasting with 150% energy intake on alternate days for 3 weeks in lean, healthy individuals (0:150; n = 12). Control groups involved a matched degree of energy restriction applied continuously without fasting (75% energy intake daily; 75:75; n = 12) or a matched pattern of fasting without net energy restriction (200% energy intake on alternate days; 0:200; n = 12). Primary outcomes were body composition, components of energy balance, and postprandial metabolism. Daily energy restriction (75:75) reduced body mass (−1.91 ± 0.99 kilograms) almost entirely due to fat loss (−1.75 ± 0.79 kilograms). Restricting energy intake via fasting (0:150) also decreased body mass (−1.60 ± 1.06 kilograms; P = 0.46 versus 75:75) but with attenuated reductions in body fat (−0.74 ± 1.32 kilograms; P = 0.01 versus 75:75), whereas fasting without energy restriction (0:200) did not significantly reduce either body mass (−0.52 ± 1.09 kilograms; P ≤ 0.04 versus 75:75 and 0:150) or fat mass (−0.12 ± 0.68 kilograms; P ≤ 0.05 versus 75:75 and 0:150). Postprandial indices of cardiometabolic health and gut hormones, along with the expression of key genes in subcutaneous adipose tissue, were not statistically different between groups (P > 0.05). Alternate-day fasting less effectively reduces body fat mass than a matched degree of daily energy restriction and without evidence of fasting-specific effects on metabolic regulation or cardiovascular health.

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A randomized controlled trial of two diets enriched with protein or fat in patients with type 2 diabetes treated with dapagliflozin

Scientific Reports ◽

10.1038/s41598-021-90879-z ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Yasuhiro Watanabe ◽

Daisuke Suzuki ◽

Nobuichi Kuribayashi ◽

Daigaku Uchida ◽

Mitsutoshi Kato ◽

...

Keyword(s):

Type 2 Diabetes ◽

Muscle Mass ◽

Body Fat ◽

Fat Mass ◽

Serum Insulin ◽

Controlled Trial ◽

Hdl Cholesterol ◽

Body Fat Mass ◽

Randomized Controlled

AbstractSodium-glucose cotranspsorter-2 (SGLT2) inhibitors (SGLT2i) involve loss of skeletal muscle mass, potentially leading to inadequate HbA1c reduction in type 2 diabetes (T2DM), since muscle mass is related to insulin sensitivity. The benefit of protein-enriched diet for improving HbA1c in SGLT2i-treated T2DM patients remains unclear. We conducted a multicenter, double-blind, randomized, controlled, investigator-initiated clinical trial. 130 T2DM patients treated with dapagliflozin (5 mg) were randomized to isoenergic protein-rich formula diet (P-FD) or fat-rich FD (F-FD) (1:1 allocation) to replace one of three meals/day for 24 weeks. Primary outcome was change in HbA1c. Secondary outcomes were changes in serum insulin, body composition and other metabolic parameters. Although HbA1c decreased significantly in both groups [mean (95% confidence interval) − 0.7% (− 0.9 to − 0.5) in P-FD, − 0.6% (− 0.8 to − 0.5) in F-FD], change in HbA1c was not significantly different between the two groups (P = 0.4474). Fasting insulin and body fat mass decreased, while HDL-cholesterol increased significantly in P-FD, and these changes were significantly greater compared with F-FD (all, P < 0.05). In T2DM treated with dapagliflozin, protein-enriched diet does not contribute to HbA1c reduction, although it decreases serum insulin and body fat mass, and increases HDL-cholesterol compared with fat-enriched diet with identical calories and carbohydrate ratio.

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