Cardiovascular Disease
Conditions
Brief summary
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
Participants will be given 1000 mg vitamin C or 800 IU vitamin E daily for 60 days.
Interventions
DIETARY_SUPPLEMENTVitamin C
1000 mg/day
DIETARY_SUPPLEMENTVitamin E
800 IU/day
DIETARY_SUPPLEMENTPlacebo
Sponsors
University of California, Berkeley
Kaiser Permanente
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in high-sensitivity C-reactive protein (hsCRP) | 8-week intervention |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed