Expired Study
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Stanford, California 94305


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.


Study summary:

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 supplement 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.


Criteria:

Inclusion Criteria:Overweight/obesity; high LDL cholesterol, pre-hypertension. Exclusion Criteria:1. Daily intake of > 5 servings of vegetables and fruits 2. Fasting blood glucose >140 mg/dL 3. BMI >40 4. Liver or renal disease; Atherosclerosis (e.g., CAD, PAD); Malignant neoplasm; Ongoing infection; Inflammatory disease 5.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 6. Pregnant or lactating 7. Inability to communicate effectively with study staff


Study is Available At:


Original ID:

SU-08202008-1284


NCT ID:

NCT00756405


Secondary ID:

7116


Study Acronym:


Brief Title:

Effects of Dietary Antioxidants on Cardiovascular Risk Factors


Official Title:

Potential Health Benefits of Dietary Antioxidants From Supplements v. Foods


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Stanford University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

90


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Christopher D Gardner
Principal Investigator
Stanford University

Study Dates

Start Date:March 2007
Completion Date:December 2008
Completion Type:Actual
Primary Completion Date:December 2008
Primary Completion Type:Actual
Verification Date:April 2010
Last Changed Date:April 29, 2010
First Received Date:September 19, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Inflammatory Markers
Time Frame:8 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Blood Lipids
Time Frame:8 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Blood Pressure
Time Frame:8 weeks
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Antioxidants from supplements vs foods

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Stanford University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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