FB4 (Framingham, Boston, Bloomington, Birmingham, and Baylor)

NCT03394664 | Terminated

• 1 other identifier: IRB-P00026977
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effects of dietary carbohydrate and sugar consumption, independent of energy content, on body fatness and metabolism in a rigorous feeding study.

Conditions

Obesity

Keywords

Body composition; Feeding study; Ketogenic diet; Weight loss; Energy Expenditure

Outcome Measures

Primary Outcomes (1)

• Body fat mass

  Body composition assessed using a multi-component model

  Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)

Secondary Outcomes (33)

• Lean body mass

  Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)

• Body weight

  Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)

• Total energy expenditure (TEE)

  Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)

• Resting energy expenditure (REE)

  Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)

• Physical activity level, (moderate to vigorous)

  Measurements made daily during 2 weeks at PWL, 2 weeks at END, and alternating non-assessment weeks of the residential phase and integrated into a unified outcome

Other Outcomes (34)

• 1,5-anhydroglucitol (1,5-AG)

  Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)

• Lipoprotein particle subfraction distribution

  Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)

• Fibrinogen

  Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)

Study Arms (3)

Very-Low Carbohydrate Diet

EXPERIMENTAL

Feeding study. Dietary composition (approximately): 75% fat

Behavioral: Feeding Study

High-Carbohydrate Low-Sugar Diet

EXPERIMENTAL

Feeding study. Dietary composition (approximately): 25% fat 0% added sugars.

Behavioral: Feeding Study

High-Carbohydrate High-Sugar Diet

EXPERIMENTAL

Feeding study. Dietary composition (approximately): 25% fat, 20% added sugars.

Behavioral: Feeding Study

Interventions

Feeding Study BEHAVIORAL

Food provision throughout the study: 1) Run-In Phase (VLC diet, weight loss); 2) Residential Phase (3 different test diets, weight-loss maintenance).

Also known as: weight loss, weight-loss maintenance

High-Carbohydrate High-Sugar Diet; High-Carbohydrate Low-Sugar Diet; Very-Low Carbohydrate Diet

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18 to 50 years
• BMI ≥ 27 kg/m2
• Weight ≤ 350 lb
• Medical clearance from a primary care provider
• Willingness to follow a VLC weight-loss diet
• Willingness to reside in a research unit for 3 months and eat/drink only provided study foods and beverages
• No major food allergies or aversions
• Willingness to obtain seasonal flu shot or provide documentation of flu shot for current flu season (winter/spring cohort only)
• Willingness to discuss work options (e.g., remote work) with employer, and make appropriate arrangements prior to the Residential phase.

You may not qualify if:

• Change in body weight ≥ 10% during prior 6 months
• Specialized diets (e.g., for medical or religious reasons)
• Chronic use of any medication or dietary supplement that could affect study outcomes (e.g., insulin, metformin, thyroxine)
• Current smoking (1 cigarette in the last week)
• Greater than moderate alcohol consumption (\> 14 drinks/wk) or history of binge drinking (≥5 drinks in 1 day within past 6 months)
• Physician diagnosis of a major medical illness or eating disorder
• History of kidney stones
• Laboratory tests: ALT\>2x upper limit; abnormal HgA1c; abnormal TSH; abnormal creatinine; abnormal uric acid (using the male upper limit for both sexes)
• Failed criminal offender background check or sex offender background check
• Use of recreational drugs
• Current diagnosis or history of kidney stones, gout, or gall stones; or removal of gall bladder
• Exercise restrictions or at high risk for complications during exercise
• Menopausal
• Any change in birth control medication during the 3 months prior to enrollment
• Pregnancy or lactation during the 12 months prior to enrollment, or intent to become pregnant during study participation

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Indiana University: collaborator
• University of Alabama at Birmingham: collaborator
• Framingham State University: collaborator
• Baylor University: collaborator

Study Sites (1)

Warren Conference Center and Inn

Ashland, Massachusetts, 01721, United States

Location

Related Publications (5)

• Ludwig DS, Friedman MI. Increasing adiposity: consequence or cause of overeating? JAMA. 2014 Jun 4;311(21):2167-8. doi: 10.1001/jama.2014.4133. No abstract available.

  PMID: 24839118 BACKGROUND

• 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.

  PMID: 22735432 BACKGROUND

• Wong MC, Bennett JP, Leong LT, Tian IY, Liu YE, Kelly NN, McCarthy C, Wong JMW, Ebbeling CB, Ludwig DS, Irving BA, Scott MC, Stampley J, Davis B, Johannsen N, Matthews R, Vincellette C, Garber AK, Maskarinec G, Weiss E, Rood J, Varanoske AN, Pasiakos SM, Heymsfield SB, Shepherd JA. Monitoring body composition change for intervention studies with advancing 3D optical imaging technology in comparison to dual-energy X-ray absorptiometry. Am J Clin Nutr. 2023 Apr;117(4):802-813. doi: 10.1016/j.ajcnut.2023.02.006. Epub 2023 Feb 14.

  PMID: 36796647 DERIVED

• Jansen LT, Yang N, Wong JMW, Mehta T, Allison DB, Ludwig DS, Ebbeling CB. Prolonged Glycemic Adaptation Following Transition From a Low- to High-Carbohydrate Diet: A Randomized Controlled Feeding Trial. Diabetes Care. 2022 Mar 1;45(3):576-584. doi: 10.2337/dc21-1970.

  PMID: 35108378 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

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• David S Ludwig, MD, PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

• David B Allison, PhD

  Indiana University, Bloomington

  PRINCIPAL INVESTIGATOR

• Cara B Ebbeling, PhD

  Boston Children's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assessors conducting analyses of biospecimens, laboratory personnel, DXA technologists, and research nurses were blinded to random group assignment. They were not involved in the randomization process or any aspects of the intervention. The statistical team worked with masked labels for the diet arms.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director, New Balance Foundation Obesity Prevention Center

Study Record Dates

• First Submitted: December 29, 2017
• First Posted: January 9, 2018
• Study Start: May 9, 2018
• Primary Completion: May 3, 2020
• Study Completion: May 3, 2020
• Last Updated: June 18, 2021

Record last verified: 2020-10

Locations

US (1)