Popular Diets Study
November 22, 2016 updated by: David S. Ludwig, MD, PhD, Boston Children's Hospital
Popular Diets, Metabolism, and CVD Risk
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
For most of the last half century, reduction in fat intake has been the primary nutritional approach for the prevention and treatment of obesity and cardiovascular disease (CVD).
Over the last few years, very low carbohydrate (Atkins-type) diets have achieved great popularity, with publication of several studies suggesting greater weight loss and improvements in CVD risk factors over 3 to 6 months.
Recently, a third dietary approach focused on glycemic index (GI) has generated interest.
However, few studies have compared the effects of these diets on body weight regulation and risk for CVD.
The primary hypotheses of this study are that any diet that lowers the postprandial rise in blood glucose (very-low-carbohydrate or low-GI) will have beneficial effects on the physiological adaptations to weight loss and on some CVD risk factors.
However, other CVD risk factors will be adversely affected by a very-low-carbohydrate vs. a low-GI diet.
Preliminary data provide strong support for these hypotheses, by showing that resting energy expenditure declines less and CVD risk factors improve more with weight loss on a low-glycemic load diet compared to a conventional low-fat diet.
This application proposes a cross-over feeding design to study the effects of three diets following 12.5% weight loss in obese young adult subjects (n = 24, age 18 to 40 years).
The diets are: 1) conventional low-fat, with 60% carb, 20% fat, 20% protein; 2) low-GI with 40% carb, 40% fat, 20% protein; and 3) very-low-carbohydrate with 10% carb, 60% fat, 30% protein.
The primary outcome is resting energy expenditure (indirect calorimetry).
Secondary outcomes include total energy expenditure (doubly labeled water), thermic effect of food (indirect calorimetry), physical activity (accelerometry), insulin resistance and B-cell function (frequently-sampled OGTT), blood lipids, blood pressure and measures of systemic inflammation and coagulopathy.
This study should have major public health implications to the millions of Americans currently following diets to decrease body weight and risk for heart disease.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Children's Hospital Boston
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: 2
Low fat diet
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Feeding protocol, all foods prepared in a metabolic kitchen
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Experimental: 1
Low glycemic index diet
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Feeding protocol, all foods prepared in a metabolic kitchen
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Active Comparator: 3
Very low carbohydrate diet
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Feeding protocol, all foods prepared in a metabolic kitchen
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
resting energy expenditure using indirect calorimetry in the fasting state
Time Frame: end of each dietary period
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end of each dietary period
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insulin resistance assessed by frequently-sampled oral glucose tolerance test
Time Frame: end of each dietary period
|
end of each dietary period
|
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thyroid function tests
Time Frame: end of each dietary period
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end of each dietary period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
total energy expenditure using doubly labeled water methodology
Time Frame: end of each dietary period
|
end of each dietary period
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thermic effect of food using indirect calorimetry
Time Frame: end of each dietary period
|
end of each dietary period
|
|
|
physical activity using accelerometry
Time Frame: end of each dietary period
|
end of each dietary period
|
|
|
serum lipids
Time Frame: end of each dietary period
|
end of each dietary period
|
|
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plasminogen activator inhibitor-1
Time Frame: end of each dietary period
|
end of each dietary period
|
|
|
C-reactive protein
Time Frame: end of each dietary period
|
end of each dietary period
|
|
|
blood pressure
Time Frame: end of each dietary period
|
end of each dietary period
|
|
|
hunger/appetite
Time Frame: end of each dietary period
|
end of each dietary period
|
|
|
insulin 30 minutes after oral glucose (as an effect modifier)
Time Frame: baseline
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baseline
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Core temperature
Time Frame: End of each dietary period
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End of each dietary period
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secreted frizzle-related protein-4
Time Frame: end of each dietary period
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end of each dietary period
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heme-oxygenase
Time Frame: end of each dietary period
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end of each dietary period
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Irisin
Time Frame: end of each dietary period
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end of each dietary period
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fibroblast growth factor-21
Time Frame: end of each dietary period
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end of each dietary period
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chemerin
Time Frame: end of each dietary period
|
end of each dietary period
|
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trimethylamine N-oxide
Time Frame: fasting and postprandial, end of each dietary period
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fasting and postprandial, end of each dietary period
|
|
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alanine aminotransferase
Time Frame: end of each dietary period
|
end of each dietary period
|
|
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Uric acid
Time Frame: end of each dietary period
|
end of each dietary period
|
|
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insulin
Time Frame: fasting and postprandial, end of each dietary period
|
fasting and postprandial, end of each dietary period
|
|
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ghrelin
Time Frame: fasting and postprandial, end of each dietary period
|
fasting and postprandial, end of each dietary period
|
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gastric inhibitory peptide
Time Frame: fasting and postprandial, end of each dietary period
|
fasting and postprandial, end of each dietary period
|
|
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GLP1
Time Frame: fasting and postprandial, end of each dietary period
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fasting and postprandial, end of each dietary period
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PYY
Time Frame: fasting and postprandial, end of each dietary period
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fasting and postprandial, end of each dietary period
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Amylin
Time Frame: fasting and postprandial, end of each dietary period
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fasting and postprandial, end of each dietary period
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Leptin
Time Frame: end of each dietary period
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end of each dietary period
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Metabolomic analysis
Time Frame: end of each dietary period
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Evaluate the effect of diet on metabolomic profile in plasma, with the aim of assessing dietary adherence and exploring diet-disease mechanisms
|
end of each dietary period
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Cara B Ebbeling, PhD, Boston Children's Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- Hron 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.
- Esko 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. Erratum In: Am J Clin Nutr. 2022 Feb 9;115(2):601.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
April 14, 2006
First Submitted That Met QC Criteria
April 14, 2006
First Posted (Estimate)
April 18, 2006
Study Record Updates
Last Update Posted (Estimate)
November 23, 2016
Last Update Submitted That Met QC Criteria
November 22, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01DK072428 (U.S. NIH Grant/Contract)
- R01DK072428 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.