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Completed

NCT Number: NCT00315354

Popular Diets Study

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

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low glycemic index diet

Other

Feeding protocol, all foods prepared in a metabolic kitchen

Low fat diet

Other

Feeding protocol, all foods prepared in a metabolic kitchen

Very low carbohydrate diet

Other

Feeding protocol, all foods prepared in a metabolic kitchen

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • Brigham and Women's Hospital
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Popular Diets, Metabolism, and CVD Risk

Important dates

Study start
2006
Primary completion
2010
Study completion
2013
First posted
Apr 18, 2006
Registry last updated
Nov 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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