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

Not Applicable

Completed

• Conditions: Cardiovascular Disease
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Vitamin C; Dietary Supplement: Vitamin E

• Registration Number: NCT00079963
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

Study Timeline

• Study First Submitted: 2004-03-18
• Study First Submitted QC: 2004-03-19
• Study First Posted: 2004-03-22
• Study Start: 2004-04
• Primary Completion: 2008-03-24
• Study Completion: 2008-03-24
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-25
• Last Update Posted: 2017-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 396

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Z	Placebo	Placebo
X	Vitamin C	Vitamin C
Y	Vitamin E	Vitamin E

Primary Outcome Measures

Name	Time	Method
Change in high-sensitivity C-reactive protein (hsCRP)	8-week intervention

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of California, Berkeley School of Public Health; 🇺🇸 Berkeley, California, United States