Metabolic Fuels Study
A Mechanistic Examination of Dietary Composition on Metabolic Fuels Availability
1 other identifier
interventional
30
1 country
4
Brief Summary
This study will evaluate a potential physiologic mechanism underlying the effects of dietary composition on control of body weight
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Oct 2014
Typical duration for not_applicable obesity
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2014
CompletedFirst Posted
Study publicly available on registry
September 9, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedJuly 21, 2017
July 1, 2017
1.6 years
September 5, 2014
July 19, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Late postprandial energy availability
Post-prandial energy availability calculated as the sum, in kcal/L, of energy from circulating metabolic fuels (glucose, non-esterified fatty acids, lactate and ketoacids), as measured during a 24 hr inpatient admission. Time of interest includes 2.5 - 5 hr in the postprandial period after breakfast, lunch and dinner.
10 - 15 weeks after initiation of test diets
Secondary Outcomes (10)
Late postprandial energy availability, with lactate excluded
10 - 15 weeks after initiation of test diets
Fasting energy availability
10 - 15 weeks after initiation of test diet
Total energy availability
10 - 15 weeks after initiation of test diets
Hunger
10 - 15 weeks after initiation of test diets
Satiety
10 - 15 weeks after initiation of test diets
- +5 more secondary outcomes
Other Outcomes (3)
Effect modification by insulin secretion
10 - 15 weeks after initiation of test diets
Adipocyte studies of anabolic status
10 - 15 weeks after initiation of test diets
Adipose tissue histology
10 - 15 weeks after initiation of test diets
Study Arms (3)
Low carbohydrate diet
ACTIVE COMPARATORModerate carbohydrate diet
ACTIVE COMPARATORHigh carbohydrate diet
ACTIVE COMPARATORInterventions
Composition (by proportion of calories) : 15% carbohydrate, 65% fat, 20% protein
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Eligibility Criteria
You may qualify if:
- Aged 18 to 65 years
- BMI ≥ 25 kg/m2
- BMI \< 40 kg/m2 and weight ≤ 300 lbs (136 kg)
- Medical clearance from a primary care provider
- Student or employee at Framingham State University throughout enrollment in the study
- Willing and able to eat and drink only the foods and beverages on the study menus
- Willing to eat in the dining hall
- Willing to abstain from consuming alcohol during participation
- Willing to undergo additional procedures in this ancillary study
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 or history of binge drinking
- 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
- Allergy or prior reaction to Lidocaine
- Medical condition or medication that would increase risk of bleeding, infection or skin reactions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Children's Hospitallead
- Framingham State Universitycollaborator
- Brigham and Women's Hospitalcollaborator
- Boston Medical Centercollaborator
- Nutrition Science Initiativecollaborator
- New Balance Foundationcollaborator
Study Sites (4)
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Framingham State University
Framingham, Massachusetts, 01702, United States
Related Publications (2)
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.
PMID: 23483989BACKGROUNDEbbeling 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: 22735432BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kim Shams, MD
Boston Children's Hospital
- PRINCIPAL INVESTIGATOR
David s Ludwig, MD, PhD
Boston Children's Hospital
- PRINCIPAL INVESTIGATOR
Cara B Ebbeling, PhD
Boston Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Obesity Prevention Center
Study Record Dates
First Submitted
September 5, 2014
First Posted
September 9, 2014
Study Start
October 1, 2014
Primary Completion
May 1, 2016
Study Completion
May 1, 2017
Last Updated
July 21, 2017
Record last verified: 2017-07