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| Sponsored by: |
Stanford University |
|---|---|
| Information provided by: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT00756405 |
Purpose
The aim of the Antioxidant Study is to compare the efficacy of foods naturally rich in antioxidants with that of antioxidants in a pill form on markers of inflammation and plasma cholesterol in healthy adults at risk of cardiovascular disease.
| Condition | Intervention |
|---|---|
|
Obesity Hyperlipidemia Insulin Resistance Hypertension |
Behavioral: Antioxidants from supplements vs foods |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Potential Health Benefits of Dietary Antioxidants From Supplements v. Foods |
| Estimated Enrollment: | 90 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | December 2008 |
Increasing the amount of antioxidants in your diet is thought to be one way to improve your health. If antioxidants do have a beneficial effect, one way to measure that is to examine possible changes in the levels of "inflammatory markers" in your blood.
Participants will be asked to consume an antioxidant supplements that may or may not include Vitamin E, Vitamin C, Beta-carotene, and Selenium or a placebo for 8 weeks. The doses of antioxidants will be similar to the amounts suggested by the United States Department of Agriculture's (USDA) recommended daily allowances (RDA). In addition, a group of participants will be asked to change their usual eating habits and consume more of certain foods that are naturally good sources of the four antioxidants contained in the pills.
Eligible participants will be asked to come to the Stanford Campus for 3 fasting blood draws over the period of 8 weeks and to complete diet and physical activity questionnaires at the beginning, middle and end of the study period.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Overweight/obesity; high LDL cholesterol, pre-hypertension.
Exclusion Criteria:
Currently taking the following medications:
Anti-inflammatory drugs Lipid lowering drugs Anti-hypertensive drugs Calcium containing drugs Drugs known to affect blood coagulation Drugs known to affect antioxidant status
Contacts and Locations| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| Principal Investigator: | Christopher D Gardner | Stanford University |
More Information
| Responsible Party: | Stanford University ( Christopher D Gardner, Principal Investigator ) |
| Study ID Numbers: | SU-08202008-1284, 7116 |
| Study First Received: | September 19, 2008 |
| Last Updated: | December 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00756405 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Obesity Antioxidants Hyperlipidemias Metabolic Diseases Vascular Diseases Overweight Body Weight Signs and Symptoms Hyperinsulinism |
Nutrition Disorders Overnutrition Insulin Resistance Glucose Metabolism Disorders Metabolic Disorder Dyslipidemias Hypertension Lipid Metabolism Disorders |
|
Obesity Antioxidants Hyperlipidemias Metabolic Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Vascular Diseases Overweight Protective Agents Pharmacologic Actions Body Weight |
Signs and Symptoms Hyperinsulinism Nutrition Disorders Cardiovascular Diseases Overnutrition Insulin Resistance Glucose Metabolism Disorders Dyslipidemias Hypertension Lipid Metabolism Disorders |
