Effects of Dietary Antioxidants on Cardiovascular Risk Factors

Christopher Gardner

Status: Completed

Conditions: Hypertension; Hyperlipidemia; Obesity

Treatments: Behavioral: Antioxidant diet; Dietary Supplement: Antioxidant supplement; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00756405

1R21AT003245-01 (U.S. NIH Grant/Contract)

SU-08202008-1284

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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88 participants in 3 patient groups, including a placebo group

Diet Group

Active Comparator group

Description:

Increased antioxidant diet and placebo pill.

Treatment:

Behavioral: Antioxidant diet

Dietary Supplement: Placebo

Supplement Group

Active Comparator group

Description:

Usual diet and antioxidant supplement.

Treatment:

Dietary Supplement: Antioxidant supplement

Placebo

Placebo Comparator group

Description:

Usual diet and placebo pill.

Treatment:

Dietary Supplement: Placebo