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Framingham State Food Study

Information source: Children's Hospital Boston
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Obesity; Diabetes; Cardiovascular Disease

Intervention: Feeding study (Behavioral)

Phase: N/A

Status: Recruiting

Sponsored by: Children's Hospital Boston

Official(s) and/or principal investigator(s):
Gloria Klein, MS, RD, Study Director, Affiliation: Children's Hospital Boston
Cara B Ebbeling, PhD, Principal Investigator, Affiliation: Children's Hospital Boston
David S Ludwig, MD, PhD, Principal Investigator, Affiliation: Children's Hospital Boston

Overall contact:
Gloria Klein, MS, RD, Phone: 617-919-3435, Email: Gloria.Klein@childrens.harvard.edu


This study will evaluate the effects of dietary composition on energy expenditure and chronic disease risk factors, while also exploring physiological mechanisms underlying these effects.

Clinical Details

Official title: Dietary Composition and Energy Expenditure During Weight-Loss Maintenance

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Total energy expenditure, assessed by indirect calorimetry using stable isotopes

Secondary outcome:

Dietary energy required to maintain weight stability during weight loss maintenance

Resting energy expenditure, assessed by indirect calorimetry using respiratory gas exchange

Physical activity, assessed by accelerometry

Glycemic control, assessed by HgA1c

Total cholesterol




Plasminogen activator inhibitor-1

C-reactive protein





Endothelial dysfunction, assessed by number and function of endothelial progenitor cells

Blood pressure

Skeletal muscle work efficiency, assessed by cycle ergometry

Insulin sensitivity (hepatic), assessed by frequently-sampled oral glucose tolerance test

Insulin sensitivity (systemic), assessed by frequently-sampled oral glucose tolerance test


Non-esterified fatty acids

Serum ketones/ketoacids


Metabolic fuel concentration in serum (glucose, nonesterified fatty acids, ketones/ketoacids, lactate)

Body composition by MRI

Thyroid stimulating hormone

Thyroxine (T4)

reverse T3

free T4

Insulin-like growth factor 1 (IGF-1)

IGF binding proteins



Luteinizing hormone

Follicle stimulating hormone

Urinary cortisol excretion

Urinary catecholamine excretion

Gut microbiome profile

Serum metabolomics profile

Ad libitum food intake

Body weight change during ad libitum feeding

Liver fat by MRS spectroscopy


Energy expenditure & work efficiency by cycle ergometry

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 55 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 (15% of energy from carbohydrate, 65% 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) at 20 weeks. Secondary outcomes during weight maintenance will include energy intake, 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 voluntary food intake and 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). We also will test each covariate for effect modification (covariate × diet interaction).


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


Inclusion Criteria:

- Aged 18 to 55 years

- BMI ≥ 25 kg/m2

- BMI < 40 kg/m2 and weight ≤ 300 lbs (136 kg)

- Medical clearance from a primary care provider

- Plans to matriculate as a student at Framingham State University or work on campus

throughout the academic year of enrollment in the study

- 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 blood glucose, TSH, CBC, BUN, Creatinine

- ALT greater than 150% of the normal upper limit

- Plans for a vacation during the study that would preclude adherence to prescribed


- 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

Locations and Contacts

Gloria Klein, MS, RD, Phone: 617-919-3435, Email: Gloria.Klein@childrens.harvard.edu

Framingham State University, Framingham, Massachusetts 01702, United States; Recruiting
Additional Information

Related publications:

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.

Walsh CO, Ebbeling CB, Swain JF, Markowitz RL, Feldman HA, Ludwig DS. Effects of diet composition on postprandial energy availability during weight loss maintenance. PLoS One. 2013;8(3):e58172. doi: 10.1371/journal.pone.0058172. Epub 2013 Mar 6.

Starting date: February 2014
Last updated: April 7, 2015

Page last updated: August 20, 2015

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