- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02068885
Framingham State Food Study ((FS)2)
Dietary Composition and Energy Expenditure During Weight-Loss Maintenance
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Many overweight and obese people can lose weight for a few months, but most have difficulty maintaining weight loss over the long term. One explanation for the poor long-term outcome of weight-loss diets relates to behavior, in that motivation to adhere to restrictive regimens typically diminishes with time. An alternative explanation is that weight loss elicits biological adaptations - specifically a decline in energy expenditure and an increase in hunger - that promote weight regain. The purpose of this study is to evaluate the effects of dietary composition on energy expenditure and risk for chronic diseases, while also exploring physiological mechanisms underlying these effects. The study will be performed in collaboration with Framingham State University, providing a novel and feasible method for feeding subjects in dining halls and monitoring compliance.
Following 12±2% weight loss on a standard run-in diet, 150 adults (aged 18 to 65 years) will be randomly assigned to one of three weight-loss maintenance diets controlled for protein content (20% of energy) and varying widely in dietary carbohydrate-to-fat ratio: Low-carbohydrate (20% of energy from carbohydrate, 60% fat), Moderate- carbohydrate (40% carbohydrate, 40% fat), High-carbohydrate (60% carbohydrate, 20% fat). During the weight-loss maintenance phase, energy intake will be adjusted to prevent changes in body weight. The primary outcome will be change in total energy expenditure (indirect calorimetry using stable isotopes) through 20 weeks. Secondary outcomes during weight maintenance will include resting energy expenditure (indirect calorimetry using respiratory gas exchange), physical activity (accelerometry), measures of insulin resistance and skeletal muscle work efficiency, components of the metabolic syndrome, and hormonal and metabolic measures that might inform an understanding of physiological mechanisms. We also will assess weight change during a 2-week ad libitum feeding phase, as an objective measure of dietary effects on hunger. The analytic framework for addressing study hypothesis will be repeated-measures analysis of variance, with adjustment for covariates (sex, race, ethnicity, age, anthropometrics, insulin sensitivity and secretion, obesity-related genes). We also will test each covariate for effect modification (covariate × diet interaction).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Framingham, Massachusetts, United States, 01702
- Framingham State University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged 18 to 65 years
- BMI ≥ 25 kg/m2
- Weight ≤ 425 lbs
- Medical clearance from a primary care provider
- Plans to matriculate at Framingham State University (campus-based participants: students), work on campus (campus-based participants: faculty and staff), or live in the greater Framingham area (community-based participants) throughout the academic year of enrollment in the study
- Academic and social clearance from the FSU Office of Enrollment and Student Development (student participants) or willingness to comply with Criminal Offender Record Information (CORI) check and Sex Offender Registry Information (SORI) check (community-based subjects)
- Willingness to eat and drink only the foods and beverages on the study menus during participation, with no food allergies or aversions
- Willingness to eat in the dining hall
- Willingness to abstain from consuming alcohol during participation
Exclusion Criteria:
- Change in body weight exceeding ±10% during prior year
- Recent adherence to a special diet
- Recent adherence to a vigorous physical activity regimen (e.g., participation in a varsity sport)
- Chronic use of any medication or dietary supplement that could affect study outcomes
- Current smoking (1 cigarette in the last week)
- Heavy baseline alcohol consumption (> 10 drinks/week) or history of binge drinking (≥ 5 drinks in 1 day, anytime in past 6 months)
- Physician diagnosis of a major medical/psychiatric illness or eating disorder
- Abnormal HgA1c, TSH, BUN, creatinine; hematocrit < 30; ALT > 200% of normal upper limit
- Plans for a vacation during the study that would preclude adherence to prescribed diet
- Additional exclusions for female participants: Irregular menstrual cycles; any change in birth control medication during the 3 months prior to enrollment; pregnancy or lactation during the 12 months prior to enrollment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low carbohydrate diet
Feeding study.
Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
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Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
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Experimental: Moderate carbohydrate diet
Feeding study.
Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
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Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
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Active Comparator: High carbohydrate diet
Feeding study.
Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
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Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Energy Expenditure, Assessed by Indirect Calorimetry Using Stable Isotopes
Time Frame: Start of Trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Total energy expenditure (TEE), assessed by indirect calorimetry using stable isotopes Total calories burned: Participants each drank about a cup of water containing special tracers which are measurable when they pass out of the body through urine. They provided a urine sample before they drank the water and then about every other day for the next two (2) weeks. Change: average (midpoint of test phase, end of test phase) - start of trial |
Start of Trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resting Energy Expenditure, Assessed by Indirect Calorimetry Using Respiratory Gas Exchange
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Resting energy expenditure, assessed by indirect calorimetry using respiratory gas exchange Calories burned while resting: Participants lied down with head and neck under a clear plastic "bubble," breathing room air. Gases in expired air were collected. Change: average (midpoint of test phase, end of test phase) - start of trial |
Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Physical Activity, Assessed by Accelerometry
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Actigraph Accelerometer Change: average (midpoint of test phase, end of test phase) - start of trial An Actigraph Accelerometer measures movement, similar to a pedometer.
Data are reported as counts (divided by 1,000) per day.
Each participant wore the the accelerometer on the right hip for 7 days at each time point.
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Skeletal Muscle Work Efficiency
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Efficiency is expressed as percentage ratio of power generated during cycle ergometry (with conversion of Watts to kcal/min using a factor of 0.01433) to energy expenditure above resting. Change: end of test phase - start of trial. |
Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Leptin (Start of Trial)
Time Frame: Start of trial (time of randomization, post-weight loss)
|
Leptin levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 6) are expressed in percentage units (100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial |
Start of trial (time of randomization, post-weight loss)
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Leptin (% Change)
Time Frame: Change through 20 weeks' weight loss maintenance
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Leptin levels were log transformed for analysis.
Change (expressed in percentage units, 100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial
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Change through 20 weeks' weight loss maintenance
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Ghrelin (Start of Trial)
Time Frame: Start of trial (time of randomization, post-weight loss)
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Ghrelin levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 8) are expressed in percentage units (100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial |
Start of trial (time of randomization, post-weight loss)
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Ghrelin (% Change)
Time Frame: Change through 20 weeks' weight loss maintenance
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Ghrelin levels were log transformed for analysis.
Change (expressed in percentage units, 100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial
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Change through 20 weeks' weight loss maintenance
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1,5-Anhydroglucitol
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Biomeasure of carbohydrate intake Change, 10 weeks: midpoint of test phase - start of trial Change, 20 weeks: end of test phase - start of trial
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Glycemic Control, Assessed by HgA1c
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Change, 10 weeks: midpoint of test phase - start of trial.
Change, 20 weeks: end of test phase - start of trial.
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Triglycerides
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Triglyceride levels were log transformed for analysis.
For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units Change, 10 weeks: midpoint of test phase - start of trial Change, 20 weeks: end of test phase - start of trial
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Body Composition (DXA)
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Body fat, presented as a % of total mass Participants each had a special scan (x-ray) to measure their amount of body fat. The special x-ray is called "dual-energy x-ray absorptiometry" (DXA). They were asked to lie still on a table for x-ray pictures. Change: end of test phase - start of trial |
Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Glucose
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Glucose level, fasting blood draw Change: end of test phase - start of trial
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Change in Lipoprotein Particle Subfraction Distribution
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Lipoprotein insulin resistance (LPIR) score was calculated from triglyceride-rich, high-density, and low-density lipoprotein particle (TRL-P, HDL-P, LDL-P) sizes and subfraction concentrations (large/very large TRL-P, large HDL-P, small LDL-P). LPIR score is quantified on a scale of 0-100. Higher scores indicate worse outcome. Change: end of test phase - start of trial |
Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Total Cholesterol
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Change: end of test phase - start of trial
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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HDL-Cholesterol
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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High-density lipoprotein cholesterol Change, 10 weeks: midpoint of test phase - start of trial.
Change, 20 weeks: end of test phase - start of trial.
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Non-HDL-Cholesterol
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Calculated by subtracting HDL-cholesterol from total cholesterol.
Change: end of test phase - start of trial
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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LDL-Cholesterol
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Low-density-lipoprotein cholesterol Change: end of test phase - start of trial
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Adiponectin (Start of Trial)
Time Frame: Start of trial (time of randomization, post-weight loss)
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Total and high molecular weight adiponectin Adiponectin levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 20) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial |
Start of trial (time of randomization, post-weight loss)
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Adiponectin (% Change)
Time Frame: Change through 20 weeks' weight loss maintenance
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Adiponeptin levels were log transformed for analysis.
Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial
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Change through 20 weeks' weight loss maintenance
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C-reactive Protein (Start of Trial)
Time Frame: Start of trial (time of randomization, post-weight loss)
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C-reactive protein, marker of inflammation C-reactive protein levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 22) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial |
Start of trial (time of randomization, post-weight loss)
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C-reactive Protein (% Change)
Time Frame: Change through 20 weeks' weight loss maintenance
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C-reactive protein, marker of inflammation C-reactive protein levels were log transformed for analysis.
Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial
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Change through 20 weeks' weight loss maintenance
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IL-6 (Start of Trial)
Time Frame: Start of trial (time of randomization, post-weight loss)
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Interleukin-6, marker of inflammation Interleukin-6 levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 24) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial |
Start of trial (time of randomization, post-weight loss)
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IL-6 (% Change)
Time Frame: Change through 20 weeks' weight loss maintenance
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Interleukin-6, marker of inflammation Interleukin-6 levels were log transformed for analysis.
Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial
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Change through 20 weeks' weight loss maintenance
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Blood Pressure
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Systolic and diastolic blood pressure Change: end of test phase - start of trial
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Plasminogen Activator Inhibitor-1 (Start of Trial)
Time Frame: Start of trial (time of randomization, post-weight loss)
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Plasminogen activator inhibitor-1 levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 27) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial |
Start of trial (time of randomization, post-weight loss)
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Plasminogen Activator Inhibitor-1 (% Change)
Time Frame: Change through 20 weeks' weight loss maintenance
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Plasminogen activator inhibitor-1 levels were log transformed for analysis.
Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial
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Change through 20 weeks' weight loss maintenance
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Fibrinogen
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Change: end of test phase - start of trial
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Insulin Secretion Determined as Blood Insulin Concentration 30 Minutes After Oral Glucose (Start of Trial)
Time Frame: Start of trial (time of randomization, post-weight loss)
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Insulin level 30 minutes after consuming 75 grams of glucose
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Start of trial (time of randomization, post-weight loss)
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Thyroxine (T4)
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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thyroid function test
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Free T4
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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free thyroxine, thyroid function test
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Thyroid Stimulating Hormone
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Produced by the pituitary gland in the brain.
Tells the thyroid gland to make thyroid hormones.
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Reverse T3
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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thyroid function test, inactive form of triiodothyronine (T3) Lifespan Bio kit was used for analysis.
The range of this kit is 250 to 5000 pg/mL, which varies from other commercially available kits (about 10-fold greater values).
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Urinary Cortisol Excretion
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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cortisol (stress hormone) excreted in the urine over a 24-hour period
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Urinary Catecholamine - Adrenaline
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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catecholamine excreted in the urine over 24 hours, also known as epinephrine
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Urinary Catecholamine - Dopamine
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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catecholamine excreted in the urine over 24 hours
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Urinary Catecholamine - Noradrenaline
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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catecholamine excreted in the urine over 24 hours, also known as norepinephrine
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Insulin Sensitivity (Hepatic), Assessed by Frequently-sampled Oral Glucose Tolerance Test
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Insulin Sensitivity (Systemic), Assessed by Frequently-sampled Oral Glucose Tolerance Test
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Non-esterified Fatty Acids
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Serum Ketones/Ketoacids
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Lactate
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Metabolic Fuel Concentration in Serum (Glucose, Nonesterified Fatty Acids, Ketones/Ketoacids, Lactate)
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Insulin-like Growth Factor 1 (IGF-1)
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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IGF Binding Proteins
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Testosterone
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Estradiol
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Luteinizing Hormone
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Follicle Stimulating Hormone
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Body Weight Change During ad Libitum Feeding
Time Frame: Ad libitum feeding period (weeks 21 and 22 following randomization)
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Ad libitum feeding period (weeks 21 and 22 following randomization)
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Gut Microbiome Profile
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Serum Metabolomics Profile
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Change in Cognitive Function Related to Memory
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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California Verbal Learning Test - Second Edition [CVLT-II] and Digit Span Test
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Change in Cognitive Function Related to Processing Speed and Executive Function
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Trail Making Test Parts A and B [TMT-A, TMT-B]
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Change in Self-reported Sleep Quality
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Change in Self-reported Depression Measure
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Beck Depression Inventory-II [BDI-II]
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Change in Self-reported Mood/Anxiety
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Mood and Anxiety Symptom Questionnaire [MASQ]
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Change in Self-reported Food Addiction Score
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Yale Food Addiction Scale [YFAS]
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Change in Self-reported Emotional Eating Score
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Emotional Eating Scale [EES]
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Change in Self-reported Binge Eating Score
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Binge Eating Scale [BES]
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect Modification by Insulin Secretion of Metabolic Responses to Diet
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Effect modifier: Insulin level 30 minutes into an standard OGTT (Insulin-30) Outcome: Total Energy Expenditure Tertiles: Pre-weight-loss Insulin-30 (Low, Moderate, High) Change: average (midpoint of test phase, end of test phase) - start of trial
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Effect Modification by Insulin Resistance of Metabolic Responses to Diet
Time Frame: Start of (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Start of (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Effect Modification by Amylase Gene Copy Number
Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Gloria Klein, MS, RD, Boston Children's Hospital
Publications and helpful links
General Publications
- Wong JM, Bielak L, Eddy RG, Stone L, Lakin PR, Sandman M, Devlin C, Seger-Shippee L, Wiroll D, Luoto PK, Klein GL, Ludwig DS, Ebbeling CB. An Academia-Industry Partnership for Planning and Executing a Community-Based Feeding Study. Curr Dev Nutr. 2018 Jul 5;2(9):nzy060. doi: 10.1093/cdn/nzy060. eCollection 2018 Sep.
- Ebbeling CB, Klein GL, Luoto PK, Wong JMW, Bielak L, Eddy RG, Steltz SK, Devlin C, Sandman M, Hron B, Shimy K, Heymsfield SB, Wolfe RR, Wong WW, Feldman HA, Ludwig DS. A randomized study of dietary composition during weight-loss maintenance: Rationale, study design, intervention, and assessment. Contemp Clin Trials. 2018 Feb;65:76-86. doi: 10.1016/j.cct.2017.12.004. Epub 2017 Dec 9.
- Ludwig DS, Greco KF, Ma C, Ebbeling CB. Testing the carbohydrate-insulin model of obesity in a 5-month feeding study: the perils of post-hoc participant exclusions. Eur J Clin Nutr. 2020 Jul;74(7):1109-1112. doi: 10.1038/s41430-020-0658-8. Epub 2020 May 20.
- Ebbeling CB, Feldman HA, Klein GL, Wong JMW, Bielak L, Steltz SK, Luoto PK, Wolfe RR, Wong WW, Ludwig DS. Effects of a low carbohydrate diet on energy expenditure during weight loss maintenance: randomized trial. BMJ. 2018 Nov 14;363:k4583. doi: 10.1136/bmj.k4583. Erratum In: BMJ. 2020 Nov 3;371:m4264.
- Ebbeling CB, Bielak L, Lakin PR, Klein GL, Wong JMW, Luoto PK, Wong WW, Ludwig DS. Energy Requirement Is Higher During Weight-Loss Maintenance in Adults Consuming a Low- Compared with High-Carbohydrate Diet. J Nutr. 2020 Aug 1;150(8):2009-2015. doi: 10.1093/jn/nxaa150.
- Wong JMW, Yu S, Ma C, Mehta T, Dickinson SL, Allison DB, Heymsfield SB, Ebbeling CB, Ludwig DS. Stimulated Insulin Secretion Predicts Changes in Body Composition Following Weight Loss in Adults with High BMI. J Nutr. 2022 Mar 3;152(3):655-662. doi: 10.1093/jn/nxab315.
- Ebbeling CB, Knapp A, Johnson A, Wong JMW, Greco KF, Ma C, Mora S, Ludwig DS. Effects of a low-carbohydrate diet on insulin-resistant dyslipoproteinemia-a randomized controlled feeding trial. Am J Clin Nutr. 2022 Jan 11;115(1):154-162. doi: 10.1093/ajcn/nqab287. Erratum In: Am J Clin Nutr. 2022 Jan 11;115(1):310.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-P00009571
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Clinical Trials on Obesity
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Central Hospital, Nancy, FranceNot yet recruiting
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University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
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Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
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Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
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Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
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Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
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Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
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The Hospital for Sick ChildrenCompleted
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Ihuoma EneliCompletedObesity, ChildhoodUnited States
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Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on Feeding study
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NestléCompleted
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University of PennsylvaniaCompleted
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University of PennsylvaniaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
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Albert Einstein College of MedicineWithdrawnCardiovascular Disease
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Penn State UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
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Penn State UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
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Marian NeuhouserDuke University; University of Washington; University of Nebraska; United States...Recruiting
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Penn State UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
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Boston Children's HospitalUniversity of Alabama at Birmingham; Indiana University; Baylor University; Framingham...Terminated
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Boston Children's HospitalKansas State UniversityWithdrawnCardiovascular Disease | Diabetes | Insulin ResistanceUnited States