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Popular Diets Study

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ClinicalTrials.gov Identifier: NCT00315354
Recruitment Status : Completed
First Posted : April 18, 2006
Last Update Posted : November 23, 2016
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Brigham and Women's Hospital
Information provided by (Responsible Party):
David S. Ludwig, MD, PhD, Boston Children's Hospital

Study Description
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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

Condition or disease Intervention/treatment Phase
Obesity Insulin Resistance Other: Low glycemic index diet Other: Low fat diet Other: Very low carbohydrate diet Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Popular Diets, Metabolism, and CVD Risk
Study Start Date : April 2006
Actual Primary Completion Date : June 2010
Actual Study Completion Date : April 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Low glycemic index diet
 Other: Low glycemic index diet
Feeding protocol, all foods prepared in a metabolic kitchen
Active Comparator: 2
Low fat diet
 Other: Low fat diet
Feeding protocol, all foods prepared in a metabolic kitchen
Active Comparator: 3
Very low carbohydrate diet
 Other: Very low carbohydrate diet
Feeding protocol, all foods prepared in a metabolic kitchen


Outcome Measures
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Primary Outcome Measures :
  1. resting energy expenditure using indirect calorimetry in the fasting state [ Time Frame: end of each dietary period ]
  2. insulin resistance assessed by frequently-sampled oral glucose tolerance test [ Time Frame: end of each dietary period ]
  3. thyroid function tests [ Time Frame: end of each dietary period ]

Secondary Outcome Measures :
  1. total energy expenditure using doubly labeled water methodology [ Time Frame: end of each dietary period ]
  2. thermic effect of food using indirect calorimetry [ Time Frame: end of each dietary period ]
  3. physical activity using accelerometry [ Time Frame: end of each dietary period ]
  4. serum lipids [ Time Frame: end of each dietary period ]
  5. plasminogen activator inhibitor-1 [ Time Frame: end of each dietary period ]
  6. C-reactive protein [ Time Frame: end of each dietary period ]
  7. blood pressure [ Time Frame: end of each dietary period ]
  8. hunger/appetite [ Time Frame: end of each dietary period ]
  9. insulin 30 minutes after oral glucose (as an effect modifier) [ Time Frame: baseline ]
  10. Core temperature [ Time Frame: End of each dietary period ]
  11. secreted frizzle-related protein-4 [ Time Frame: end of each dietary period ]
  12. heme-oxygenase [ Time Frame: end of each dietary period ]
  13. Irisin [ Time Frame: end of each dietary period ]
  14. fibroblast growth factor-21 [ Time Frame: end of each dietary period ]
  15. chemerin [ Time Frame: end of each dietary period ]
  16. trimethylamine N-oxide [ Time Frame: fasting and postprandial, end of each dietary period ]
  17. alanine aminotransferase [ Time Frame: end of each dietary period ]
  18. Uric acid [ Time Frame: end of each dietary period ]
  19. insulin [ Time Frame: fasting and postprandial, end of each dietary period ]
  20. ghrelin [ Time Frame: fasting and postprandial, end of each dietary period ]
  21. gastric inhibitory peptide [ Time Frame: fasting and postprandial, end of each dietary period ]
  22. GLP1 [ Time Frame: fasting and postprandial, end of each dietary period ]
  23. PYY [ Time Frame: fasting and postprandial, end of each dietary period ]
  24. Amylin [ Time Frame: fasting and postprandial, end of each dietary period ]
  25. Leptin [ Time Frame: end of each dietary period ]
  26. Metabolomic analysis [ Time Frame: end of each dietary period ]
    Evaluate the effect of diet on metabolomic profile in plasma, with the aim of assessing dietary adherence and exploring diet-disease mechanisms


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00315354


Locations
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United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children's Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Brigham and Women's Hospital
Investigators
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Principal Investigator: David S Ludwig, MD, PhD Boston Children's Hospital
Study Director: Cara B Ebbeling, PhD Boston Children's Hospital
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: David S. Ludwig, MD, PhD, Professor, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT00315354    
Other Study ID Numbers: 1R01DK072428 ( U.S. NIH Grant/Contract )
R01DK072428 ( U.S. NIH Grant/Contract )
First Posted: April 18, 2006    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: November 2016
Keywords provided by David S. Ludwig, MD, PhD, Boston Children's Hospital:
obesity
nutrition
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases