A Novel Diet-Phenotype Interaction Affecting Body Weight (FRESH Start)

This study has been completed.
University of North Carolina, Chapel Hill
Broad Institute
Information provided by (Responsible Party):
David S. Ludwig, MD, PhD, Children's Hospital Boston
ClinicalTrials.gov Identifier:
First received: February 22, 2011
Last updated: February 8, 2016
Last verified: February 2016
The primary aim of the study is to examine insulin secretion as an effect modifier of the efficacy of a low-fat vs. low-glycemic load diet for weight loss among overweight/obese young adults in an 18-month, prospectively stratified, multi-center randomized controlled trial.

Condition Intervention
Metabolic Syndrome
Behavioral: Dietary counselling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Novel Diet-Phenotype Interaction Affecting Body Weight

Resource links provided by NLM:

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Percent body fat by dual-energy x-ray absorptiometry (DXA) [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Triglyceride [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • HDL cholesterol [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • LDL cholesterol [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • C-reactive protein [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Plasminogen Activator Inhibitor-1 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Fasting blood glucose [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Insulin resistance [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Trunk fat [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Serum insulin concentration 30 minutes following a standard 75-gram oral glucose load [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Effect modification

  • Metabolomic profile [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Effect modification

  • Insulin sensitivity [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Effect modification

  • Abdominal-to-total fat ratio [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Effect modification

  • Waist-to-hip ratio [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Effect modification

Enrollment: 155
Study Start Date: February 2011
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low glycemic load diet
Low glycemic load diet
Behavioral: Dietary counselling
Active Comparator: Low fat diet
Low fat diet
Behavioral: Dietary counselling

Detailed Description:
In recent years, diets of widely varying composition have been used in the treatment of obesity. While none of these diets has produced consistent, long-term weight loss, some individuals on virtually all types of diets do remarkably well. One explanation for this variation among individuals is differences in motivation and behavior. However, underlying biological differences may also play an important role. Previous work has identified insulin secretion (as quantified by serum insulin concentration at 30 minutes following a standard 75-gram oral glucose load) as an important biological determinant. This randomized-controlled, multi-center trial aims to test the hypothesis that insulin secretion will predict which type of diet will work best for each individual. A total of 160 obese young adults (18 to 40 years) will be assigned to one of two diets: low-fat (60% carbohydrate, 20% fat, 20% protein) or low-glycemic load (45% carbohydrate, 35% fat, 20% protein). Participants will be enrolled at two sites (Children's Hospital Boston or University of North Carolina-Chapel Hill) and assigned to diet groups according to baseline insulin secretion status. The protocol will include an intensive 6-month intervention period and a 12-month follow-up period. Registered dietitians will provide nutrition education and behavioral counseling during group workshops and scheduled telephone calls. In an effort to avoid confounding, close attention will be paid to control for treatment intensity, physical activity prescriptions, and behavioral methods between groups. The primary endpoint will be percent body fat by DXA scan. Secondary endpoints will include cardiovascular and diabetes risk factors. Repeated, 24-hour dietary and physical activity recall interviews will provide process data. Metabolomic profiling and molecular analysis of identified metabolites will be conducted to characterize phenotype and explore potential physiological mechanisms. A successful outcome of this work will inform the practice of "personalized" nutritional therapy, enhancing the ability to select the most efficacious weight loss diet for an individual based on underlying biological differences.

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria

  • Aged 18 to 40 years.
  • Body mass index (BMI) ≥ 27 kg/m2.
  • Body weight ≤ 300 lb.
  • Access to a working telephone.
  • Clearance in writing from a primary care provider (i.e., physician or nurse practitioner) to rule out pre-existing medical conditions.
  • Willing and able to attend group workshops (for dietary intervention) on specified evenings.

Exclusion Criteria

  • Physician diagnosis of a major medical illness or eating disorder.
  • Chronic use of any medication that may affect study outcomes (e.g., insulin-sensitizing agents).
  • Current smoking (i.e., 1 cigarette in the past week).
  • Physical, mental, or cognitive handicaps that prevent participation.
  • Another member of the family (i.e., first degree relative) or household participating in the study.
  • Planning to relocate from current area of residence during the proposed timeframe for study participation.
  • If female, planning to become pregnant during the 18 months of the study.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01303757

United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
United States, North Carolina
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States
Sponsors and Collaborators
Children's Hospital Boston
University of North Carolina, Chapel Hill
Broad Institute
Study Director: Cara B Ebbeling, PhD Children's Hospital Boston
Principal Investigator: David S Ludwig, MD, PhD Children's Hospital Boston
Study Director: Leslie Fischer, PhD UNC Chapel Hill
  More Information

Responsible Party: David S. Ludwig, MD, PhD, Director, Obesity Prevention Center, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01303757     History of Changes
Other Study ID Numbers: 10-04-0156 
Study First Received: February 22, 2011
Last Updated: February 8, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:

Additional relevant MeSH terms:
Body Weight
Metabolic Syndrome X
Glucose Metabolism Disorders
Insulin Resistance
Metabolic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 26, 2016