Intermittent energy restriction is comparable to continuous energy restriction for cardiometabolic health in adults with central obesity: A randomized controlled trial; the Met-IER study

Very low energy diets (VLEDs), commonly achieved by replacing all food with meal replacement products and which result in fast weight loss, are the most effective dietary obesity treatment available. VLEDs are also cheaper to administer than conventional, food-based diets, which result in slow weight loss. Despite being effective and affordable, these diets are underutilized by healthcare professionals, possibly due to concerns about potential adverse effects on body composition and eating disorder behaviors. This paper describes the rationale and detailed protocol for the TEMPO Diet Trial (Type of Energy Manipulation for Promoting optimal metabolic health and body composition in Obesity), in a randomized controlled trial comparing the long-term (3-year) effects of fast versus slow weight loss. One hundred and one post-menopausal women aged 45–65 years with a body mass index of 30–40 kg/m2 were randomized to either: (1) 16 weeks of fast weight loss, achieved by a total meal replacement diet, followed by slow weight loss (as for the SLOW intervention) for the remaining time up until 52 weeks (“FAST” intervention), or (2) 52 weeks of slow weight loss, achieved by a conventional, food-based diet (“SLOW” intervention). Parameters of body composition, cardiometabolic health, eating disorder behaviors and psychology, and adaptive responses to energy restriction were measured throughout the 3-year trial.

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Gut Microbiota Is Linked to Physical Health Improvements Resulting from Energy-Restricted Diet and Exercise: A Randomized Controlled Trial in Healthy Adults

Proceedings ◽

10.3390/iecn2020-06992 ◽

2020 ◽

Vol 61 (1) ◽

pp. 8

Author(s):

Shakuntla Gondalia ◽

Matthew Cooke ◽

Stephen Keenan ◽

Regina Belski

Keyword(s):

Randomized Controlled Trial ◽

Resistance Training ◽

Gut Microbiota ◽

Physical Health ◽

Gut Microbiome ◽

Controlled Trial ◽

Energy Restriction ◽

Restricted Diet ◽

Randomized Controlled ◽

Continuous Energy

Animal studies have demonstrated that energy-restricted diets and exercise affect the gut microbiome and are positively linked to physical health; however, less is known about the impacts of various patterns of dietary restriction combined with exercise on the gut microbiota and associated health outcomes in humans. This study aimed to determine if an energy-restricted diet combined with resistance training altered the gut microbiome, and whether any changes were associated with differences in body composition, dietary intake, or biomarkers of metabolic health. Twenty-six healthy males and females, aged 19–36 years with BMIs of 22–35 kg/m2, were enrolled in a 2-arm parallel, randomized controlled trial and followed either a 5:2 intermittent fasting (IFT, n = 13) or continuous energy restriction (CERT, n = 13) diet combined with supervised resistance training for 12 weeks. Both treatments resulted in decreased body weight and increased lean body mass. Shifts in the abundance of, Faecalibacterium prausnitzii, a high butyrate producer, was positively associated with changes in lean body mass (IFTp = 0.05, CERTp = 0.01) in both the groups. Moreover, in the CERT group, changes in Coprococcus genus were negatively associated with energy (p = 0.009) and fat intake (p= 0.03) and positively associated with body fat (p = 0.02). Overall, the findings indicate that using resistance training paired with either intermittent or continuous energy restriction, result in similar changes in bacterial diversity and shifts in relative abundance of bacterial taxa. The shift in specific bacterial taxa were positively associated with measures of physical health providing further support to the proposed relationship between energy consumption, exercise, gut microbiota, and physical health.

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A randomized controlled trial of pharmacist-led therapeutic carbohydrate and energy restriction in type 2 diabetes

Nature Communications ◽

10.1038/s41467-021-25667-4 ◽

2021 ◽

Vol 12 (1) ◽

Author(s):

Cody Durrer ◽

Sean McKelvey ◽

Joel Singer ◽

Alan M. Batterham ◽

James D. Johnson ◽

...

Keyword(s):

Type 2 Diabetes ◽

Randomized Controlled Trial ◽

Safety Concern ◽

Controlled Trial ◽

Community Pharmacists ◽

Energy Restriction ◽

Cardiometabolic Health ◽

Glucose Lowering ◽

Randomized Controlled

AbstractType 2 diabetes can be treated, and sometimes reversed, with dietary interventions; however, strategies to implement these interventions while addressing medication changes are lacking. We conducted a 12-week pragmatic, community-based parallel-group randomized controlled trial (ClinicalTrials.gov: NCT03181165) evaluating the effect of a low-carbohydrate (<50 g), energy-restricted diet (~850-1100 kcal/day; Pharm-TCR; n = 98) compared to treatment-as-usual (TAU; n = 90), delivered by community pharmacists, on glucose-lowering medication use, cardiometabolic health, and health-related quality of life. The Pharm-TCR intervention was effective in reducing the need for glucose-lowering medications through complete discontinuation of medications (35.7%; n = 35 vs. 0%; n = 0 in TAU; p < 0.0001) and reduced medication effect score compared to TAU. These reductions occurred concurrently with clinically meaningful improvements in hemoglobin A1C, anthropometrics, blood pressure, and triglycerides (all p < 0.0001). These data indicate community pharmacists are a viable and innovative option for implementing short-term nutritional interventions for people with type 2 diabetes, particularly when medication management is a safety concern.

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Contrary to the Conclusions Stated in the Paper, Only Dry Fat-Free Mass Was Different between Groups upon Reanalysis. Comment on: “Intermittent Energy Restriction Attenuates the Loss of Fat-Free Mass in Resistance Trained Individuals. A Randomized Controlled Trial”

Journal of Functional Morphology and Kinesiology ◽

10.3390/jfmk5040085 ◽

2020 ◽

Vol 5 (4) ◽

pp. 85

Author(s):

Jackson Peos ◽

Andrew W. Brown ◽

Colby J. Vorland ◽

David B. Allison ◽

Amanda Sainsbury

Keyword(s):

Randomized Controlled Trial ◽

Body Composition ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Resting Metabolic Rate ◽

Energy Restriction ◽

Fat Free Mass ◽

Randomized Controlled ◽

Continuous Energy ◽

Randomised Controlled

Campbell and colleagues recently published a randomised controlled trial investigating the effects of diets involving intermittent energy restriction versus continuous energy restriction on changes in body composition and resting metabolic rate (RMR) in resistance-trained adults[...]

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Abstract MP72: Feasibility, Safety and Acceptability of Soy-Based Diet for Pregnant Women: Preliminary Results From a Pilot Randomized Controlled Trial

Circulation ◽

10.1161/circ.137.suppl_1.mp72 ◽

2018 ◽

Vol 137 (suppl_1) ◽

Author(s):

Ling Shi ◽

Vidya Iyer ◽

Errol Norwitz ◽

Tiffany A Moore Simas ◽

Nirupa Matthan ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Adverse Events ◽

Pregnant Women ◽

Health Effects ◽

Cardiometabolic Risk ◽

Controlled Trial ◽

Cardiometabolic Health ◽

Randomized Controlled ◽

Pilot Randomized Controlled Trial ◽

Whole Foods

Introduction: Previous evidence suggests that soy containing foods may have beneficial effects on lipid and glycemic metabolism due to their biologically active components, including soy protein and isoflavones. Pregnancy is associated with changes in glucose and lipid metabolism, partially attributable to elevated estrogen concentrations. We have previously reported a significant, inverse association between urinary excretion of isoflavones and cardiometabolic risk markers in pregnant women, using data from the National Health and Nutrition Examination Survey (NHANES). Further studies are needed to determine the cardiometabolic health effects of soy intake in pregnant women. Hypothesis: We hypothesize that consumption of soy-based whole foods is safe and acceptable for pregnant women and has beneficial cardiometabolic health effects. Methods: A pilot randomized controlled trial (RCT) was conducted in 30 pregnant women who received counseling to consume either a high-soy or low-soy foods containing diet. Assessments (physical and anthropometric measurements, food frequency questionnaires, fasting blood samples) were conducted at 14 and 28 weeks of pregnancy, and 6 weeks’ postpartum. Monthly follow-up calls were conducted by research team coordinator to assess safety and encourage adherence. Results: Both the high-soy and low-soy groups demonstrated high adherence (80-90%), defined as consuming soy foods ≥ 15 days in the past four weeks for high-soy group and ≤ 5 days for low-soy group. Five subjects in the high-soy group reported adverse events (nausea, vomiting, diarrhea, itchy mouth); all were transient and resolved without sequelae. No adverse events were reported in the low-soy group. Skinfold thickness decreased (-4.8 mm) in the high-soy group and increased (+3.6 mm) in the low-soy group (p=0.04). There was a trend towards lower BMI in the high-soy compared to low-soy group at 28 weeks (+1.4 vs. +3.6 kg/m 2 , respectively, p=0.15) and postpartum (-1.2 vs. +0.6 kg/m 2 , respectively, p=0.14). This decrease in BMI was predominantly a loss of body fat and not lean mass. There were no significant differences between groups in fasting glucose, HDL-C, LDL-C, TG, or VLDL concentrations. Conclusions: In conclusion, results from this pilot RCT support the acceptability and safety of consuming soy-based whole foods during pregnancy. A larger-scale RCT is needed to further elucidate the effects of soy-based foods on cardiometabolic risk factors during pregnancy, as well as the transgenerational effects on their offspring.

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Effects of Oxandrolone on Cardiometabolic Health in Boys with Klinefelter syndrome: A Randomized Controlled Trial

The Journal of Clinical Endocrinology & Metabolism ◽

10.1210/jc.2016-2904 ◽

2016 ◽

pp. jc.2016-2904 ◽

Cited By ~ 4

Author(s):

Shanlee M. Davis ◽

Matthew Cox-Martin ◽

Martha Bardsley ◽

Karen Kowal ◽

Philip S. Zeitler ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Klinefelter Syndrome ◽

Controlled Trial ◽

Cardiometabolic Health ◽

Randomized Controlled

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Effect of a lifestyle intervention in obese infertile women on cardiometabolic health and quality of life: A randomized controlled trial

PLoS ONE ◽

10.1371/journal.pone.0190662 ◽

2018 ◽

Vol 13 (1) ◽

pp. e0190662 ◽

Cited By ~ 19

Author(s):

Lotte van Dammen ◽

Vincent Wekker ◽

Anne M. van Oers ◽

Meike A. Q. Mutsaerts ◽

Rebecca C. Painter ◽

...

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Lifestyle Intervention ◽

Controlled Trial ◽

Cardiometabolic Health ◽

Infertile Women ◽

Randomized Controlled

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Hybrid Neuromuscular Training Improves Cardiometabolic Health and Alters Redox Status in Inactive Overweight and Obese Women: A Randomized Controlled Trial

Antioxidants ◽

10.3390/antiox10101601 ◽

2021 ◽

Vol 10 (10) ◽

pp. 1601

Author(s):

Alexios Batrakoulis ◽

Athanasios Z. Jamurtas ◽

Dimitrios Draganidis ◽

Kalliopi Georgakouli ◽

Panagiotis Tsimeas ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Redox Status ◽

Atherogenic Index ◽

Neuromuscular Training ◽

Cardiometabolic Health ◽

Obese Women ◽

Cvd Risk ◽

Randomized Controlled ◽

Hybrid Type

This randomized controlled trial investigated the effects of a 5-month high-intensity hybrid-type neuromuscular training program with nontraditional implements on cardiometabolic health, redox status, and cardiovascular disease (CVD) risk in inactive overweight and obese women. Forty-nine inactive female participants with overweight and obesity (age: 36.4 ± 4.4 years; BMI: 29.1 ± 2.9 kg/m2) were randomly assigned to either a control (C, n = 21) or a training group (TR, n = 28). TR followed a 20-week supervised, progressive, time-efficient (3 days/week; 6–15 min net exercise time) program implementing loaded fundamental movement patterns with prescribed work-to-rest time intervals (20–40 s, 1:2, 1:1, 2:1) in a circuit fashion (2–3 rounds). Cardiometabolic risk factors were measured at baseline and post-training as secondary outcomes of a larger randomized controlled trial. At post-intervention, TR demonstrated favorable changes in resting heart rate (−7%, p = 0.043), high-density lipoprotein (+18.1%, p = 0.029), atherogenic index (−17%, p = 0.045), mean arterial pressure (−4.5%, p = 0.03), waist circumference (−6.2%, p = 0.005), waist-to-hip ratio (−4.6%; p = 0.015), metabolic syndrome severity score (−222%, p = 0.024), full 30-year CVD risk (−15.8%, p = 0.002) and hard 30-year CVD risk (−17.6%, p = 0.01), vascular age (−7.8%, p = 0.002), protein carbonyls (−45.7%, p = 0.001), catalase activity (+15.2%, p = 0.023), and total antioxidant capacity (+11.4%, p = 0.002) relative to C. Additionally, TR induced beneficial changes in fasting glucose (−3.4%, p = 0.002), homeostatic model assessment for insulin resistance (−15.7%, p < 0.001), diastolic blood pressure (−5.6%, p < 0.001), reduced glutathione (+39.8%, p < 0.001), 10-year CVD risk (−17.4%, p = 0.011), and total bilirubin (−21.7%, p < 0.001) compared to baseline. These results suggest that hybrid-type neuromuscular training may improve aspects of cardiometabolic health and antioxidant status in inactive overweight and obese women providing a time-efficient (~100 min/week) exercise approach in a real-world gym setting.

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A Reply to Contrary to the Conclusions Stated in the Paper, Only Dry Fat-Free Mass Was Different between Groups upon Reanalysis—Comment on: “Intermittent Energy Restriction Attenuates the Loss of Fat-Free Mass in Resistance Trained Individuals: A Randomized Controlled Trial”

Journal of Functional Morphology and Kinesiology ◽

10.3390/jfmk5040086 ◽

2020 ◽

Vol 5 (4) ◽

pp. 86

Author(s):

Bill I. Campbell

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Energy Restriction ◽

Fat Free Mass ◽

Randomized Controlled

We would like to thank Dr [...]

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