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Comparison of Two Different Diets on Health Outcomes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University of Virginia.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00269646
First received: December 21, 2005
Last updated: February 16, 2009
Last verified: February 2009
History of Changes
  Purpose

The purpose of this study is to compare the effects of a low-carbohydrate diet and a high-carbohydrate, high-fiber diet, on insulin sensitivity and blood chemicals considered risk markers for heart disease, in persons with the metabolic syndrome.

Our primary hypothesis is that the ad libitum high-carbohydrate, high-fiber diet will significantly improve insulin sensitivity, whereas the ad libitum low-carbohydrate, low-fiber diet will not.


Condition Intervention
Metabolic Syndrome X
 Behavioral: Low-carbohydrate and high-carbohydrate diets

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effect of a Low-Carbohydrate and High-Carbohydrate, High-Fiber Diet on Insulin Sensitivity and Risk Markers for Cardiovascular Disease in Men and Women With the Metabolic Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • insulin sensitivity [ Time Frame: before and after one month on each diet ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total and LDL-cholesterol [ Time Frame: before and after one month on each diet ] [ Designated as safety issue: No ]
  • C-reactive protein [ Time Frame: before and after one month on each diet ] [ Designated as safety issue: No ]
  • Homocysteine [ Time Frame: before and after one month on each diet ] [ Designated as safety issue: No ]
  • Fibrinogen [ Time Frame: before and after one month on each diet ] [ Designated as safety issue: No ]
  • Cytokines IL-1, IL-2, IL-6 and TNF-alpha [ Time Frame: before and after one month on each diet ] [ Designated as safety issue: No ]
  • Leukocyte adhesion molecules [ Time Frame: before and after one month on each diet ] [ Designated as safety issue: No ]
  • Flow-mediated dilation [ Time Frame: before and after one month on each diet ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: November 2004
Estimated Study Completion Date: August 2009
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Low-carbohydrate and high-carbohydrate diets
    Each subject will consume two different ad libitum diets, each for four weeks, with a 4-week washout period inbetween each diet.
Detailed Description:

Low-carbohydrate eating is becoming perceived as more than just a weight loss diet, but rather a means to improve health. Several studies have been published suggesting that low-carbohydrate diets may be preferable to low-fat diets for weight loss and in terms of some health markers. On the other hand, considerable evidence suggests that low-carbohydrate diets, high in fat, are associated with a number of adverse health outcomes. The health benefits of high-carbohydrate, high-fiber diets have also been demonstrated. This study is designed to assess the differences between the two different dietary strategies in terms of a number of health outcomes. Participants will consume, in random order, a non-calorie-restricted low-carbohydrate and a non-calorie-restricted high-carbohydrate, high-fiber diet for one month, with a 4-6 week washout period in between.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

1. Subjects must meet the criteria of the metabolic syndrome, which is defined as having three or more of the following:

  • Waist circumference: >94 cm for males; >80 cm for females
  • Blood Pressure: >130/85 mmHg
  • HDL-Chol (mg/dl): <50 women; <40 men)
  • Triglycerides (mg/dl): >150
  • Glucose (mg/dl): >100 2. Subjects must meet age requirement 3. Subjects must be nonsmokers 4. Subjects must be willing to provide written consent 5. Subjects must be willing to pick-up up meals at the GCRC and return uneaten food 6. Have no food allergies 7. Subjects must not be currently following any particular diet, and must not have intentionally lost weight by dieting during the previous 3 months 8. Subjects must not be taking nutritional supplements other than a daily multivitamin 9. Subjects must be willing to maintain current physical activity routine, which cannot exceed the equivalent of > 30 minutes per day of moderate-intensity activity 10. Blood hematocrit must be at least 40 for men and 36 for women.

Exclusion Criteria:

1. Does not meet the criteria for the metabolic syndrome 2. Does not meet age requirement 3. Smoker 4. Pregnancy 5. Food allergies 6. Unwillingness to provide written consent 7. Personal history of cardiovascular disease, including prior myocardial infarction, angioplasty, or bypass surgery 8. Known cardiovascular or metabolic diseases (e.g., diabetes) 9. Currently using medications to control blood pressure, lipids, or glucose 10. Currently on a diet or has attempted weight loss by dieting during the past 3 months 11. Currently taking nutritional supplements other than a daily multivitamin 12. Currently exercising more than the equivalent of 30 minutes/day of moderate-intensity physical activity 13. Currently on oral contraceptives 14. Hematocrit below 40 for men or below 36 for women 15. Baseline systolic blood pressure below 100 mmHg

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00269646

Locations
United States, Virginia
University of Virginia General Clinical Research Center
Charlottesville, Virginia, United States, 22904
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Glenn A Gaesser, PhD University of Virginia
  More Information

No publications provided

Responsible Party: Glenn Gaesser/Principal Investigator, University of Virginia
ClinicalTrials.gov Identifier: NCT00269646     History of Changes
Other Study ID Numbers: HIC11487
Study First Received: December 21, 2005
Last Updated: February 16, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
Diet
Low-carbohydrate
Insulin
 Dietary fiber
Diabetes
Cardiovascular disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Metabolic Syndrome X
Insulin Resistance
 Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 23, 2013