Gender, Obesity, C-Reactive Protein, and Oxidative Stress

Study Overview
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Brief Summary
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This randomized placebo-controlled trial will test whether supplementing with vitamins C and E can lower markers of inflammation and oxidative stress in healthy adults. We will examine whether one antioxidant vitamin is more effective than another, and whether gender or body fat influence the treatment effects. We will also determine whether gender, body fat, or menopausal status are associated with baseline concentrations of inflammation and oxidative stress markers.

Detailed Description
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Participants will be given 1000 mg vitamin C or 800 IU vitamin E daily for 60 days.

Official Title
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Gender, Obesity, C-Reactive Protein, and Oxidative Stress

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Dietary Supplement: Vitamin C
* Dietary Supplement: Vitamin E
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Nonsmoker and not passively exposed Males and females 18 year and older Able to take vitamin supplements Able to take acetominophen instead of aspirin or NSAIDs during the study Exclusion criteria: Pregnancy or lactation History of ever smoking or passive smoke exposure in the last year Active liver disease; history of HIV/AIDS, diabetes, kidney stones, hemochromatosis, or autoimmune diseases; heart disease, stroke, or cancer in the last 5 years User of prescribed anti-inflammatory or lipid-lowering medications, oral contraceptives, hormone replacement therapy, or blood-thinning drugs User of iron supplements or vitamin E at 600 IU per day or more Consumption of more than 2 alcoholic beverages per day

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 |
| --- | --- |
| Experimental: X<br>Vitamin C | Dietary Supplement: Vitamin C<br>* 1000 mg/day<br>|
| Experimental: Y<br>Vitamin E | Dietary Supplement: Vitamin E<br>* 800 IU/day<br>|
| Placebo Comparator: Z<br>Placebo | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in high-sensitivity C-reactive protein (hsCRP) |  | 8-week intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood pressure |  | 8-week intervention | 
| Change in self-reported stress and psychosocial factors |  | 8-week intervention | 
| Change in oxidative stress biomarkers (F2-Isoprostanes, malondialdehyde) |  | 8-week intervention | 
| Association of gender, body fat, menopausal status with baseline concentrations of inflammation and oxidative stress biomarkers. |  | Baseline |