Effects of Dietary Antioxidants on Cardiovascular Risk Factors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-12-31

Brief Summary

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The aim of the Antioxidant Study was 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.

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Detailed Description

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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 were asked to consume an antioxidant supplement including carotenoids, mixed tocopherols, vitamin C 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 (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 were 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.

Conditions

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Obesity Hyperlipidemia Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Diet Group

Increased antioxidant diet and placebo pill.

Group Type ACTIVE_COMPARATOR

Antioxidant diet

Intervention Type BEHAVIORAL

Participants were asked to increase antioxidant-rich food intake to approximately double their daily habitual intake and take a placebo pill.

Placebo

Intervention Type DIETARY_SUPPLEMENT

Participants were asked to consume their usual diet and take a placebo pill.

Supplement Group

Usual diet and antioxidant supplement.

Group Type ACTIVE_COMPARATOR

Antioxidant supplement

Intervention Type DIETARY_SUPPLEMENT

Participants were asked to consume their usual diet and take a supplement containing carotenoids, mixed tocopherols, vitamin C and selenium, designed to approximately double their daily habitual intake.

Placebo

Usual diet and placebo pill.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Participants were asked to consume their usual diet and take a placebo pill.

Interventions

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Antioxidant diet

Participants were asked to increase antioxidant-rich food intake to approximately double their daily habitual intake and take a placebo pill.

Intervention Type BEHAVIORAL

Antioxidant supplement

Participants were asked to consume their usual diet and take a supplement containing carotenoids, mixed tocopherols, vitamin C and selenium, designed to approximately double their daily habitual intake.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Participants were asked to consume their usual diet and take a placebo pill.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes