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
Summary
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 maintenanceResting energy expenditure, assessed by indirect calorimetry using respiratory gas exchange Physical activity, assessed by accelerometry Glycemic control, assessed by HgA1c Total cholesterol HDL-cholesterol LDL-cholesterol Triglycerides Plasminogen activator inhibitor-1 C-reactive protein IL-6 Fibrinogen Leptin Adiponectin 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 Glucose Non-esterified fatty acids Serum ketones/ketoacids Lactate 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 Testosterone Estradiol 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 non-HDL-cholesterol 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).
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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
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
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
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