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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

Tracking Information
First Submitted Date  ICMJE April 14, 2006
First Posted Date  ICMJE April 18, 2006
Last Update Posted Date November 23, 2016
Study Start Date  ICMJE April 2006
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2007)
  • resting energy expenditure using indirect calorimetry in the fasting state [ Time Frame: end of each dietary period ]
  • insulin resistance assessed by frequently-sampled oral glucose tolerance test [ Time Frame: end of each dietary period ]
  • thyroid function tests [ Time Frame: end of each dietary period ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 14, 2006)
  • resting energy expenditure using indirect calorimetry in the fasting state
  • insulin resistance assessed by frequently-sampled IV glucose tolerance test
  • thyroid function tests
Change History Complete list of historical versions of study NCT00315354 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2016)
  • total energy expenditure using doubly labeled water methodology [ Time Frame: end of each dietary period ]
  • thermic effect of food using indirect calorimetry [ Time Frame: end of each dietary period ]
  • physical activity using accelerometry [ Time Frame: end of each dietary period ]
  • serum lipids [ Time Frame: end of each dietary period ]
  • plasminogen activator inhibitor-1 [ Time Frame: end of each dietary period ]
  • C-reactive protein [ Time Frame: end of each dietary period ]
  • blood pressure [ Time Frame: end of each dietary period ]
  • hunger/appetite [ Time Frame: end of each dietary period ]
  • insulin 30 minutes after oral glucose (as an effect modifier) [ Time Frame: baseline ]
  • Core temperature [ Time Frame: End of each dietary period ]
  • secreted frizzle-related protein-4 [ Time Frame: end of each dietary period ]
  • heme-oxygenase [ Time Frame: end of each dietary period ]
  • Irisin [ Time Frame: end of each dietary period ]
  • fibroblast growth factor-21 [ Time Frame: end of each dietary period ]
  • chemerin [ Time Frame: end of each dietary period ]
  • trimethylamine N-oxide [ Time Frame: fasting and postprandial, end of each dietary period ]
  • alanine aminotransferase [ Time Frame: end of each dietary period ]
  • Uric acid [ Time Frame: end of each dietary period ]
  • insulin [ Time Frame: fasting and postprandial, end of each dietary period ]
  • ghrelin [ Time Frame: fasting and postprandial, end of each dietary period ]
  • gastric inhibitory peptide [ Time Frame: fasting and postprandial, end of each dietary period ]
  • GLP1 [ Time Frame: fasting and postprandial, end of each dietary period ]
  • PYY [ Time Frame: fasting and postprandial, end of each dietary period ]
  • Amylin [ Time Frame: fasting and postprandial, end of each dietary period ]
  • Leptin [ Time Frame: end of each dietary period ]
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2006)
  • total energy expenditure using doubly labeled water methodology
  • thermic effect of food using indirect calorimetry
  • physical activity using accelerometry
  • serum lipids
  • plasminogen activator inhibitor-1
  • C-reactive protein
  • blood pressure
  • other hormones (in addition to thyroid-related hormones)
  • hunger/appetite
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Popular Diets Study
Official Title  ICMJE Popular Diets, Metabolism, and CVD Risk
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
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Obesity
  • Insulin Resistance
Intervention  ICMJE
  • Other: Low glycemic index diet
    Feeding protocol, all foods prepared in a metabolic kitchen
  • Other: Low fat diet
    Feeding protocol, all foods prepared in a metabolic kitchen
  • Other: Very low carbohydrate diet
    Feeding protocol, all foods prepared in a metabolic kitchen
Study Arms  ICMJE
  • Experimental: 1
    Low glycemic index diet
    Intervention: Other: Low glycemic index diet
  • Active Comparator: 2
    Low fat diet
    Intervention: Other: Low fat diet
  • Active Comparator: 3
    Very low carbohydrate diet
    Intervention: Other: Very low carbohydrate diet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 14, 2006)
24
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00315354
Other Study ID Numbers  ICMJE 1R01DK072428( U.S. NIH Grant/Contract )
R01DK072428 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David S. Ludwig, MD, PhD, Boston Children’s Hospital
Study Sponsor  ICMJE Boston Children’s Hospital
Collaborators  ICMJE
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Brigham and Women's Hospital
Investigators  ICMJE
Principal Investigator: David S Ludwig, MD, PhD Boston Children’s Hospital
Study Director: Cara B Ebbeling, PhD Boston Children’s Hospital
PRS Account Boston Children’s Hospital
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP