Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03394664
Other study ID # IRB-P00026977
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date May 9, 2018
Est. completion date May 3, 2020

Study information

Verified date October 2020
Source Boston Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate the effects of dietary carbohydrate and sugar consumption, independent of energy content, on body fatness and metabolism in a rigorous feeding study.


Description:

Many people with obesity can lose weight for a few months, but most have difficulty maintaining weight loss over the long term. Extensive research has shown that weight loss elicits biological adaptations - including a decline in energy expenditure and an increase in hunger - that promote weight regain. However, this observation leaves unanswered why average body weight has recently increased among populations that are mostly genetically stable. According to the Carbohydrate-Insulin Model, increased consumption of processed carbohydrates during the low-fat diet era of the last 40 years has raised the average body weight being defended by biological mechanisms on a population basis. Specifically, the investigators hypothesize that diets high in total carbohydrate (with or without added sugar) acting through increased insulin secretion, alter substrate partitioning toward storage in body fat, leading to increased hunger, slowing metabolism, and accumulation of body fat. To test this hypothesis, the investigators plan a randomized-controlled feeding study involving 125 adults with obesity. During the run-in phase, participants will be given a hypocaloric very-low-carbohydrate (VLC) diet, with adjustment of energy intake to produce 15 ± 3% weight loss over 3 to 4 months on an outpatient basis. After weight stabilization, participants will be admitted to a residential center for 13 weeks. During the first 3 weeks, energy intake and expenditure will be closely monitored during weight-loss maintenance. Then, energy intake will be individually "locked" at levels equal to energy expenditure and participants will be administered one of three randomly-assigned test diets for 10 weeks. The test diets include VLC, High Carbohydrate-Low Sugar (HC-LS), and High Carbohydrate-High Sugar (HC-HS).


Recruitment information / eligibility

Status Terminated
Enrollment 166
Est. completion date May 3, 2020
Est. primary completion date May 3, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Aged 18 to 50 years - BMI = 27 kg/m2 - Weight = 350 lb - Medical clearance from a primary care provider - Willingness to follow a VLC weight-loss diet - Willingness to reside in a research unit for 3 months and eat/drink only provided study foods and beverages - No major food allergies or aversions - Willingness to obtain seasonal flu shot or provide documentation of flu shot for current flu season (winter/spring cohort only) - Willingness to discuss work options (e.g., remote work) with employer, and make appropriate arrangements prior to the Residential phase. Exclusion Criteria: - Change in body weight = 10% during prior 6 months - Specialized diets (e.g., for medical or religious reasons) - Chronic use of any medication or dietary supplement that could affect study outcomes (e.g., insulin, metformin, thyroxine) - Current smoking (1 cigarette in the last week) - Greater than moderate alcohol consumption (> 14 drinks/wk) or history of binge drinking (=5 drinks in 1 day within past 6 months) - Physician diagnosis of a major medical illness or eating disorder - History of kidney stones - Laboratory tests: ALT>2x upper limit; abnormal HgA1c; abnormal TSH; abnormal creatinine; abnormal uric acid (using the male upper limit for both sexes) - Failed criminal offender background check or sex offender background check - Use of recreational drugs - Current diagnosis or history of kidney stones, gout, or gall stones; or removal of gall bladder - Exercise restrictions or at high risk for complications during exercise Female-specific exclusion criteria: - Menopausal - Any change in birth control medication during the 3 months prior to enrollment - Pregnancy or lactation during the 12 months prior to enrollment, or intent to become pregnant during study participation

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Feeding Study
Food provision throughout the study: 1) Run-In Phase (VLC diet, weight loss); 2) Residential Phase (3 different test diets, weight-loss maintenance).

Locations

Country Name City State
United States Warren Conference Center and Inn Ashland Massachusetts

Sponsors (5)

Lead Sponsor Collaborator
Boston Children's Hospital Baylor University, Framingham State University, Indiana University, University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (2)

Ebbeling CB, Swain JF, Feldman HA, Wong WW, Hachey DL, Garcia-Lago E, Ludwig DS. Effects of dietary composition on energy expenditure during weight-loss maintenance. JAMA. 2012 Jun 27;307(24):2627-34. doi: 10.1001/jama.2012.6607. — View Citation

Ludwig DS, Friedman MI. Increasing adiposity: consequence or cause of overeating? JAMA. 2014 Jun 4;311(21):2167-8. Erratum in: JAMA. 2014 Jun 4;311(21):2168. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other 1,5-anhydroglucitol (1,5-AG) Possible future analyses of archived specimen Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Other Lipoprotein particle subfraction distribution Possible future analyses of archived specimen Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Other Fibrinogen Possible future analyses of archived specimen Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Other Interleukin-6 (IL-6) Possible future analyses of archived specimen Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Other Reverse triiodothyronine (rT3) Possible future analyses of archived specimen Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Other Insulin-like growth factor-binding protein 3 (IGF-BP3) Possible future analyses of archived specimen Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Other Luteinizing hormone (LH) Possible future analyses of archived specimen Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Other Follicle stimulating hormone (FSH) Possible future analyses of archived specimen Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Other Estradiol (E2) Possible future analyses of archived specimen Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Other Testosterone (TST, total) Possible future analyses of archived specimen Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Other Testosterone (TST, free) Possible future analyses of archived specimen Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Other Metabolomics profile Possible future analyses of archived specimen Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Other Biomarker of cholesterol synthesis Possible future analyses of archived specimen Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Other Biomarker of cholesterol absorption Possible future analyses of archived specimen Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Other MicroRNA Possible future analyses of archived specimen Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Other Gut microbiome Possible future analyses of archived specimen Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Other Demographics (mediator/modifier) Baseline covariate Pre-weight loss baseline
Other Body composition (mediator/modifier) Baseline covariate Pre-weight loss baseline
Other Measure of glucose homeostasis (insulin-30) (mediator/modifier) Baseline covariate Pre-weight loss baseline
Other Measure of glucose homeostasis (insulin sensitivity) (mediator/modifier) Baseline covariate Pre-weight loss baseline
Other Measure of glucose homeostasis (glycemic control) (mediator/modifier) Baseline covariate Pre-weight loss baseline
Other Obesity related genetic risk (mediator/modifier) Baseline covariate Pre-weight loss baseline
Other Body composition (mediator/modifier) Time varying covariate Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Other Measure of glucose homeostasis (insulin-30) (mediator/modifier) Time varying covariate Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Other Measure of glucose homeostasis (insulin sensitivity) (mediator/modifier) Time varying covariate Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Other Measure of glucose homeostasis (glycemic control) (mediator/modifier) Time varying covariate Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Other Physical activity level (moderate to vigorous) (mediator/modifier) Time varying covariate for total minutes of moderate to vigorous intensity physical activity, assessed by accelerometry. Measurements made daily during 2 weeks at PWL, 2 weeks at END, and alternating non-assessment weeks of the residential phase and integrated into a unified outcome
Other Sex Hormone-Binding Globulin (SHBG) Possible future analysis of archived specimen Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Other Urinary nitrogen Archived for future analysis End of residential (END, 10 weeks)
Other Glucagon-like peptide-1 (GLP-1) Possible future analyses of archived samples Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Other Glucose-dependent insulinotropic polypeptide (GIP) Possible future analyses of archived samples Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Other Glucagon Possible future analyses of archived samples Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Other Oxytocin Possible future analyses of archived samples Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Other Oxyntomodulin Possible future analyses of archived samples Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Primary Body fat mass Body composition assessed using a multi-component model Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Secondary Lean body mass Assessed using a multi-component model (difference between total body mass and fat mass) Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Secondary Body weight Anthropometrics, assessed by calibrated scale, in kilograms (kg) Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Secondary Total energy expenditure (TEE) Assessed using doubly labeled water methodology Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Secondary Resting energy expenditure (REE) Assessed by indirect calorimetry using respiratory gas exchange methodology with a ventilated hood system Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Secondary Physical activity level, (moderate to vigorous) Total minutes of moderate- to vigorous-intensity physical activity, assessed by accelerometry Measurements made daily during 2 weeks at PWL, 2 weeks at END, and alternating non-assessment weeks of the residential phase and integrated into a unified outcome
Secondary Insulin sensitivity Assessed by frequently-sampled oral glucose tolerance test [OGTT], calculated using plasma insulin and glucose values Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Secondary Insulin secretion Assessed by frequently-sampled oral glucose tolerance test [OGTT], using plasma insulin at 30 minutes following the dose of dextrose Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Secondary Glycemic control Hemoglobin A1c [HbA1c] Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Secondary Total cholesterol Chronic disease risk factor Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Secondary HDL-cholesterol Chronic disease risk factor Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Secondary LDL-cholesterol Chronic disease risk factor Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Secondary Non-HDL cholesterol Chronic disease risk factor Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Secondary Triglycerides Chronic disease risk factor Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Secondary Plasminogen Activator Inhibitor-1 [PAI-1] Indicator of coagulopathy Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Secondary High-sensitivity C-reactive protein [hsCRP] Indicator of chronic inflammation Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Secondary Uric acid Indicator of risk for kidney stones, measured in blood Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Secondary Systolic blood pressure Assessed by auscultation, mmHg Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Secondary Diastolic blood pressure Assessed by auscultation, mmHg Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Secondary Thyroxine (T4) Thyroid function Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Secondary Free T4 Thyroid function Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Secondary Thyroid stimulating hormone [TSH] Thyroid function Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Secondary Insulin-like growth factor-1 [IGF-1] Growth hormone action Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Secondary Urine cortisol Stress hormone, assessed using 24-hour urine collection Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Secondary Urine catecholamines Stress hormone, assessed using 24-hour urine collection Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Secondary Leptin Adipokine Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Secondary Total Adiponectin Adipokine Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Secondary High-molecular weight adiponectin Adipokine Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Secondary Sleep Total sleep time, sleep onset latency, wake after sleep onset, and sleep efficiency, assessed by accelerometry Measurements made daily during 2 weeks at PWL, 2 weeks at END, and alternating non-assessment weeks of the residential phase and integrated into a unified outcome
Secondary Blood glucose Assessed by continuous glucose monitoring (CGM) Measurements made daily during residential phase (0 to 10 weeks) and integrated into a unified outcome
Secondary Ghrelin Hormonal Control of Appetite Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Secondary Body Circumference Assessed using a 3D body scan Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Secondary Post-prandial energy expenditure and respiratory quotient Optional testing, assessed by indirect calorimetry using respiratory gas exchange Single assessment in weeks 6 to 8 of residential study
Secondary Activation of insulin signaling pathways Assessed by immunohistochemistry of phosphorylated insulin receptor and signaling proteins Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
See also
  Status Clinical Trial Phase
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2