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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Gladys Block, University of California, Berkeley Identifier:
First received: March 18, 2004
Last updated: September 25, 2014
Last verified: September 2014
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.

Condition Intervention
Cardiovascular Disease
Dietary Supplement: Vitamin C
Dietary Supplement: Vitamin E
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Gender, Obesity, C-Reactive Protein, and Oxidative Stress

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Change in high-sensitivity C-reactive protein (hsCRP) [ Time Frame: 8-week intervention ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 396
Study Start Date: April 2004
Estimated Study Completion Date: December 2016
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: X Dietary Supplement: Vitamin C
1000 mg/day
Experimental: Y Dietary Supplement: Vitamin E
800 IU/day
Placebo Comparator: Z Dietary Supplement: Placebo

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00079963

United States, California
University of California, Berkeley School of Public Health
Berkeley, California, United States, 94720-7360
Sponsors and Collaborators
University of California, Berkeley
Principal Investigator: Gladys Block, Ph.D. University of California at Berkeley
  More Information

No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Gladys Block, Professor, University of California, Berkeley Identifier: NCT00079963     History of Changes
Other Study ID Numbers: 62378DK 
Study First Received: March 18, 2004
Last Updated: September 25, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs processed this record on February 07, 2016