Popular Diets Study
Popular Diets, Metabolism, and CVD Risk
2 other identifiers
interventional
24
1 country
1
Brief Summary
The aim of this study is to evaluate the effects of three dominant dietary patterns - conventional low-fat, low-glycemic index (GI) and very-low-carbohydrate - on energy metabolism and heart disease risk factors following weight loss in obese young adults in a feeding study
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 Apr 2006
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 14, 2006
CompletedFirst Posted
Study publicly available on registry
April 18, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedNovember 23, 2016
November 1, 2016
4.2 years
April 14, 2006
November 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
resting energy expenditure using indirect calorimetry in the fasting state
end of each dietary period
insulin resistance assessed by frequently-sampled oral glucose tolerance test
end of each dietary period
thyroid function tests
end of each dietary period
Secondary Outcomes (26)
total energy expenditure using doubly labeled water methodology
end of each dietary period
thermic effect of food using indirect calorimetry
end of each dietary period
physical activity using accelerometry
end of each dietary period
serum lipids
end of each dietary period
plasminogen activator inhibitor-1
end of each dietary period
- +21 more secondary outcomes
Study Arms (3)
1
EXPERIMENTALLow glycemic index diet
2
ACTIVE COMPARATORLow fat diet
3
ACTIVE COMPARATORVery low carbohydrate diet
Interventions
Eligibility Criteria
You may qualify if:
- BMI ≥ 27 kg/m2
- Willing and able to come to the GCRC 5 days per week to consume a supervised meal and pick-up food for all other meals
- Available for scheduled hospital admissions
- Willing to abstain from alcohol consumption for the duration of the study
- If female, regular menstrual cycles (defined as 26 to 30 days between cycles; no more than one day variation in the duration of menstrual flow)
You may not qualify if:
- Weight \> 350 lbs
- Change in body weight (± 10%) over preceding year
- Taking any medications or dietary supplements that might affect body weight, appetite, or energy expenditure
- Smoking (1 cigarette in the last week)
- High levels of physical activity
- Currently following a special diet
- Abnormal laboratory screening tests
- Type 2 diabetes mellitus
- Allergies or aversions to foods on the study menu
- Previous diagnosis of an eating disorder or any other mental health disorder
- If female, pregnant in the past 12 months or planning to become pregnant during the study period
- If female, lactating in the preceding 12 months
- If taking birth control medication, change in medication in previous 3 months or plans to change medication during the study period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital Boston
Boston, Massachusetts, 02115, United States
Related Publications (5)
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: 23483989RESULTEbbeling 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: 22735432RESULTAngelidi 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. doi: 10.1038/s41467-026-68353-z. Online ahead of print.
PMID: 41547934DERIVEDHron BM, Ebbeling CB, Feldman HA, Ludwig DS. Hepatic, adipocyte, enteric and pancreatic hormones: response to dietary macronutrient composition and relationship with metabolism. Nutr Metab (Lond). 2017 Jul 5;14:44. doi: 10.1186/s12986-017-0198-y. eCollection 2017.
PMID: 28694840DERIVEDEsko T, Hirschhorn JN, Feldman HA, Hsu YH, Deik AA, Clish CB, Ebbeling CB, Ludwig DS. Metabolomic profiles as reliable biomarkers of dietary composition. Am J Clin Nutr. 2017 Mar;105(3):547-554. doi: 10.3945/ajcn.116.144428. Epub 2017 Jan 11.
PMID: 28077380DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David S Ludwig, MD, PhD
Boston Children's Hospital
- STUDY DIRECTOR
Cara B Ebbeling, PhD
Boston Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 14, 2006
First Posted
April 18, 2006
Study Start
April 1, 2006
Primary Completion
June 1, 2010
Study Completion
April 1, 2013
Last Updated
November 23, 2016
Record last verified: 2016-11