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Framingham State Food Study ((FS)2)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Framingham State University
Baylor College of Medicine
Nutrition Science Initiative
New Balance Foundation
Many Voices Foundation
Blue Cross Blue Shield
Information provided by (Responsible Party):
David S. Ludwig, MD, PhD, Boston Children's Hospital
ClinicalTrials.gov Identifier:
NCT02068885
First received: February 20, 2014
Last updated: September 19, 2017
Last verified: September 2017
  Purpose
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.

Condition Intervention
Obesity Diabetes Cardiovascular Disease Behavioral: Feeding study

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dietary Composition and Energy Expenditure During Weight-Loss Maintenance

Resource links provided by NLM:


Further study details as provided by David S. Ludwig, MD, PhD, Boston Children's Hospital:

Primary Outcome Measures:
  • Total energy expenditure, assessed by indirect calorimetry using stable isotopes [ Time Frame: Baseline through 20 weeks weight loss maintenance ]

Secondary Outcome Measures:
  • Resting energy expenditure, assessed by indirect calorimetry using respiratory gas exchange [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • Physical activity, assessed by accelerometry [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • Glycemic control, assessed by HgA1c [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • Total cholesterol [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • HDL-cholesterol [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • LDL-cholesterol [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • Triglycerides [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • Plasminogen activator inhibitor-1 [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • C-reactive protein [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • IL-6 [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • Fibrinogen [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • Leptin [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • Adiponectin [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • Blood pressure [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • Insulin sensitivity (hepatic), assessed by frequently-sampled oral glucose tolerance test [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • Insulin sensitivity (systemic), assessed by frequently-sampled oral glucose tolerance test [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • Glucose [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • Non-esterified fatty acids [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • Serum ketones/ketoacids [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • Lactate [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • Metabolic fuel concentration in serum (glucose, nonesterified fatty acids, ketones/ketoacids, lactate) [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • Body composition (4-compartment model) [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • Thyroid stimulating hormone [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • Thyroxine (T4) [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • reverse T3 [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • free T4 [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • Insulin-like growth factor 1 (IGF-1) [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • IGF binding proteins [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • Testosterone [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • Estradiol [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • Luteinizing hormone [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • Follicle stimulating hormone [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • Urinary cortisol excretion [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • Urinary catecholamine excretion [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • Gut microbiome profile [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • Serum metabolomics profile [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • Ad libitum food intake [ Time Frame: 2-week ad libitum phase after weight loss maintenance ]
  • Body weight change during ad libitum feeding [ Time Frame: 2-week ad libitum phase after weight loss maintenance ]
  • non-HDL-cholesterol [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • Energy expenditure & work efficiency by cycle ergometry [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • Change in blood ghrelin level [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • Change in lipoprotein particle subfraction distribution [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • Change in self-reported sleep quality [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • Change in self-reported depression measure [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
    Beck Depression Inventory-II [BDI-II]

  • Change in self-reported mood/anxiety [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
    Mood and Anxiety Symptom Questionnaire [MASQ]

  • Change in self-reported food addition score [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
    Yale Food Addiction Scale [YFAS]

  • Change in self-reported emotional eating score [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
    Emotional Eating Scale [EES]

  • Change in self-reported binge eating score [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
    Binge Eating Scale [BES]

  • Change in cognitive function related to memory [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
    California Verbal Learning Test - Second Edition [CVLT-II] and Digit Span Test

  • Change in cognitive function related to processing speed and executive function [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
    Trail Making Test Parts A and B [TMT-A, TMT-B]

  • Insulin secretion determined as blood insulin concentration 30 minutes after oral glucose [ Time Frame: Baseline through 20 weeks weight loss maintenance ]
  • C-Peptide [ Time Frame: Baseline through end of study (20 weeks weight loss maintenance) ]
  • 1,5-Anhydroglucitol [ Time Frame: Baseline through end of study (20 weeks weight loss maintenance) ]

Other Outcome Measures:
  • Effect modification by insulin secretion of metabolic responses to diet [ Time Frame: Baseline insulin-30 modifying response at end of study ]
    Effect modifier: Insulin level 30 minutes into an standard OGTT (Insulin-30)

  • Effect modification by insulin resistance of metabolic responses to diet [ Time Frame: Baseline through end of study ]
  • Effect modification by amylase gene copy number [ Time Frame: Baseline through end of study (20 weeks weight loss maintenance) ]

Enrollment: 164
Study Start Date: February 2014
Estimated Study Completion Date: December 2017
Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low carbohydrate diet
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Behavioral: Feeding study
Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
Experimental: Moderate carbohydrate diet
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Behavioral: Feeding study
Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
Active Comparator: High carbohydrate diet
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Behavioral: Feeding study
Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum

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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02068885

Locations
United States, Massachusetts
Framingham State University
Framingham, Massachusetts, United States, 01702
Sponsors and Collaborators
Boston Children’s Hospital
Framingham State University
Baylor College of Medicine
Nutrition Science Initiative
New Balance Foundation
Many Voices Foundation
Blue Cross Blue Shield
Investigators
Study Director: Gloria Klein, MS, RD Boston Children’s Hospital
Principal Investigator: Cara B Ebbeling, PhD Boston Children’s Hospital
Principal Investigator: David S Ludwig, MD, PhD Boston Children’s Hospital
  Study Documents (Full-Text)

Documents provided by David S. Ludwig, MD, PhD, Boston Children's Hospital:
Statistical Analysis Plan  [PDF] September 12, 2017

  More Information

Publications:
Responsible Party: David S. Ludwig, MD, PhD, Director, Obesity Prevention Center, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT02068885     History of Changes
Other Study ID Numbers: IRB-P00009571
Study First Received: February 20, 2014
Last Updated: September 19, 2017

Keywords provided by David S. Ludwig, MD, PhD, Boston Children's Hospital:
Low carbohydrate diet
Low fat diet
Glycemic index
Weight loss maintenance

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 21, 2017