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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2010 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Recruitment status was Active, not recruiting

First Received on March 18, 2004. Last Updated on January 14, 2010 History of Changes

Sponsor:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00079963

Purpose

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

Resource links provided by NLM:

MedlinePlus related topics: Obesity Vitamin C Vitamin E

Drug Information available for: Ascorbic acid alpha-Tocopherol DL-alpha-Tocopherol Vitamin E Tocopherols Tocotrienol

U.S. FDA Resources

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00079963

Locations

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

Sponsors and Collaborators

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

Investigators

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 ClinicalTrials.gov Identifier (NCT Number):

Block G, Shaikh N, Jensen CD, Volberg V, Holland N. Serum vitamin C and other biomarkers differ by genotype of phase 2 enzyme genes GSTM1 and GSTT1. Am J Clin Nutr. 2011 Sep;94(3):929-37. Epub 2011 Aug 3.

Block G, Jensen CD, Morrow JD, Holland N, Norkus EP, Milne GL, Hudes M, Dalvi TB, Crawford PB, Fung EB, Schumacher L, Harmatz P. The effect of vitamins C and E on biomarkers of oxidative stress depends on baseline level. Free Radic Biol Med. 2008 Aug 15;45(4):377-84. Epub 2008 Apr 16.

ClinicalTrials.gov Identifier:	NCT00079963 History of Changes
Other Study ID Numbers:	62378DK
Study First Received:	March 18, 2004
Last Updated:	January 14, 2010
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Cardiovascular Diseases
Ascorbic Acid
Vitamin E
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on February 09, 2012