NCT00269646

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

February 18, 2009

Status Verified

February 1, 2009

Enrollment Period

3.3 years

First QC Date

December 21, 2005

Last Update Submit

February 16, 2009

Conditions

Metabolic Syndrome X

Keywords

DietLow-carbohydrateInsulinDietary fiberDiabetesCardiovascular disease

Outcome Measures

Primary Outcomes (1)

  • insulin sensitivity

    before and after one month on each diet

Secondary Outcomes (7)

  • Total and LDL-cholesterol

    before and after one month on each diet

  • C-reactive protein

    before and after one month on each diet

  • Homocysteine

    before and after one month on each diet

  • Fibrinogen

    before and after one month on each diet

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

    before and after one month on each diet

  • +2 more secondary outcomes

Interventions

Low-carbohydrate and high-carbohydrate dietsBEHAVIORAL

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

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia General Clinical Research Center

Charlottesville, Virginia, 22904, United States

Location

MeSH Terms

Conditions

Metabolic SyndromeInsulin ResistanceDiabetes MellitusCardiovascular Diseases

Interventions

Diet, High-Protein Low-Carbohydrate

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-RestrictedDiet TherapyNutrition TherapyTherapeuticsDiet, High-ProteinDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Glenn A Gaesser, PhD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2005

First Posted

December 23, 2005

Study Start

November 1, 2004

Primary Completion

February 1, 2008

Study Completion

August 1, 2009

Last Updated

February 18, 2009

Record last verified: 2009-02

Locations

US(1)