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

September 25, 2017 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

396

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Berkeley, California, United States, 94720-7360
        • University of California, Berkeley School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: X
Vitamin C
Dietary supplement: Vitamin C
1000 mg/day
Experimental: Y
Vitamin E
Dietary supplement: Vitamin E
800 IU/day
Placebo Comparator: Z
Placebo
Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

University of California, Berkeley
Kaiser Permanente

Investigators

  • Principal Investigator: Gladys Block, Ph.D., University of California at Berkeley

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

March 24, 2008

Study Completion (Actual)

March 24, 2008

Study Registration Dates

First Submitted

March 18, 2004

First Submitted That Met QC Criteria

March 19, 2004

First Posted (Estimate)

March 22, 2004

Study Record Updates

Last Update Posted (Actual)

September 27, 2017

Last Update Submitted That Met QC Criteria

September 25, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 62378DK
  • R01DK062378 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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