Comparison of Two Different Diets on Health Outcomes

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Primary Purpose

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Low-carbohydrate and high-carbohydrate diets

About this trial

This is an interventional treatment trial for Metabolic Syndrome X focused on measuring Diet, Low-carbohydrate, Insulin, Dietary fiber, Diabetes, Cardiovascular disease

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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 -

Sites / Locations

University of Virginia General Clinical Research Center

Outcomes

Primary Outcome Measures

insulin sensitivity

Secondary Outcome Measures

Total and LDL-cholesterol

C-reactive protein

Homocysteine

Fibrinogen

Cytokines IL-1, IL-2, IL-6 and TNF-alpha

Leukocyte adhesion molecules

Flow-mediated dilation

Full Information

NCT ID

NCT00269646

First Posted

December 21, 2005

Last Updated

February 16, 2009

Sponsor

University of Virginia

1. Study Identification

Unique Protocol Identification Number

NCT00269646

Brief Title

Comparison of Two Different Diets on Health Outcomes

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Unknown status

Study Start Date

November 2004 (undefined)

Primary Completion Date

February 2008 (Actual)

Study Completion Date

August 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University of Virginia

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome X

Keywords

Diet, Low-carbohydrate, Insulin, Dietary fiber, Diabetes, Cardiovascular disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Behavioral

Intervention Name(s)

Low-carbohydrate and high-carbohydrate diets

Intervention Description

Each subject will consume two different ad libitum diets, each for four weeks, with a 4-week washout period inbetween each diet.

Primary Outcome Measure Information:

Title

insulin sensitivity

Time Frame