Effects of Dietary Antioxidants on Cardiovascular Risk Factors

Study Overview
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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.

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.

Official Title
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Potential Health Benefits of Dietary Antioxidants From Supplements v. Foods

Conditions
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Obesity, Hyperlipidemia, Hypertension

Intervention / Treatment
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* Behavioral: Antioxidant diet
* Dietary Supplement: Antioxidant supplement
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diet Group<br>Increased antioxidant diet and placebo pill. | Behavioral: Antioxidant diet<br>* Participants were asked to increase antioxidant-rich food intake to approximately double their daily habitual intake and take a placebo pill.<br>Dietary Supplement: Placebo<br>* Participants were asked to consume their usual diet and take a placebo pill.<br>|
| Active Comparator: Supplement Group<br>Usual diet and antioxidant supplement. | Dietary Supplement: Antioxidant supplement<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Usual diet and placebo pill. | Dietary Supplement: Placebo<br>* Participants were asked to consume their usual diet and take a placebo pill.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in inflammatory Markers [monocyte chemotactic protein-1 (MCP-1), interleukin-6 (IL-6), and soluble intercellular adhesion molecule-1 (sICAM-1)] at 8 weeks | Change was calculated as the value at 8 weeks minus the value at baseline | Baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood concentrations of antioxidants at baseline and 8 weeks | Blood concentrations of carotenoids, tocopherols, selenium, and vitamin C (to validate dietary change) | Baseline and 8 weeks | 
| Dietary antioxidants | Dietary intake of carotenoids, tocopherols, selenium, and vitamin C (as measured by 3-day dietary recalls) | Baseline and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adults, Antioxidants, Inflammatory markers, Diet, Supplements