Comparison of Two Different Diets on Health Outcomes

Status unconfirmed · Not applicable

Conditions studied: Metabolic Syndrome X

In brief

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.

Key facts

Study ID

NCT00269646

Run by

University of Virginia

People needed

24

Starts

2004-11-01

Expected to finish

2009-08-01

Last updated by the study team

2009-02-18

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Virginia General Clinical Research Center — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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