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

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)396 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

396

Conditions

Cardiovascular Disease

Interventions

Vitamin CDIETARY_SUPPLEMENT

1000 mg/day

Vitamin EDIETARY_SUPPLEMENT

800 IU/day

PlaceboDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of California, Berkeley School of Public Health

Berkeley, California, United States

Outcomes

Primary Outcomes

Change in high-sensitivity C-reactive protein (hsCRP)

Time frame: 8-week intervention

Secondary Outcomes

Change in blood pressure

Time frame: 8-week intervention

Change in self-reported stress and psychosocial factors

Time frame: 8-week intervention

Change in oxidative stress biomarkers (F2-Isoprostanes, malondialdehyde)

Time frame: 8-week intervention

Association of gender, body fat, menopausal status with baseline concentrations of inflammation and oxidative stress biomarkers.

Time frame: Baseline

Data from ClinicalTrials.gov

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