Framingham State Food Study

NCT02068885 | Completed Results

• 1 other identifier: IRB-P00009571
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Diabetes; Cardiovascular Disease

Keywords

Low carbohydrate diet; Low fat diet; Glycemic index; Weight loss maintenance

Outcome Measures

Primary Outcomes (1)

• Total Energy Expenditure, Assessed by Indirect Calorimetry Using Stable Isotopes

  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

Secondary Outcomes (59)

• Resting Energy Expenditure, Assessed by Indirect Calorimetry Using Respiratory Gas Exchange

  Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

• Physical Activity, Assessed by Accelerometry

  Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

• Skeletal Muscle Work Efficiency

  Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

• Leptin (Start of Trial)

  Start of trial (time of randomization, post-weight loss)

• Leptin (% Change)

  Change through 20 weeks' weight loss maintenance

Other Outcomes (3)

• Effect Modification by Insulin Secretion of Metabolic Responses to Diet

  Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

• Effect Modification by Insulin Resistance of Metabolic Responses to Diet

  Start of (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

• Effect Modification by Amylase Gene Copy Number

  Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

Study Arms (3)

Low carbohydrate diet

EXPERIMENTAL

Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein

Behavioral: Feeding study

Moderate carbohydrate diet

EXPERIMENTAL

Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein

Behavioral: Feeding study

High carbohydrate diet

ACTIVE COMPARATOR

Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein

Behavioral: Feeding study

Interventions

Feeding study BEHAVIORAL

Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum

High carbohydrate diet; Low carbohydrate diet; Moderate carbohydrate diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Framingham State University: collaborator
• Baylor College of Medicine: collaborator
• Nutrition Science Initiative: collaborator
• New Balance Foundation: collaborator
• Many Voices Foundation: collaborator
• Blue Cross Blue Shield: collaborator

Study Sites (1)

Framingham State University

Framingham, Massachusetts, 01702, United States

Location

Related Publications (8)

• 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.

  PMID: 30283914 BACKGROUND

• 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.

  PMID: 29233719 BACKGROUND

• 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.

  PMID: 32435054 BACKGROUND

• 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.

  PMID: 30429127 RESULT

• 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.

  PMID: 32470981 RESULT

• Angelidi AM, Bartell E, Huang Y, Zeleznik OA, Estanyol-Torres N, Mi MY, Bhupathiraju SN, Kelly RS, Wittenbecher C, Lasky-Su J, Clish CB, Ludwig DS, Ebbeling CB, Hirschhorn JN. Weight-independent effects of dietary carbohydrate-to-fat ratio on metabolomic profiles: secondary outcomes of a 5-month randomized controlled feeding trial. Nat Commun. 2026 Jan 17;17(1):1662. doi: 10.1038/s41467-026-68353-z.

  PMID: 41547934 DERIVED

• 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.

  PMID: 34587231 DERIVED

• 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.

  PMID: 34582545 DERIVED

MeSH Terms

Conditions

Obesity; Diabetes Mellitus; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

The study has three main limitations: potential measurement error, non-compliance, and generalizability.

Results Point of Contact

• Title: Cara Ebbeling, PhD, Co-Director, New Balance Foundation Obesity Prevention Center
• Organization: Boston Children's Hospital

Cara.Ebbeling@childrens.harvard.edu

617-919-3457

Study Officials

• Gloria Klein, MS, RD

  Boston Children's Hospital

  STUDY DIRECTOR

• Cara B Ebbeling, PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

• David S Ludwig, MD, PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Obesity Prevention Center

Study Record Dates

• First Submitted: February 20, 2014
• First Posted: February 21, 2014
• Study Start: August 17, 2014
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: January 9, 2026
• Results First Posted: November 4, 2020

Record last verified: 2022-03

Locations

US (1)