Clinical trial NCT00079963: Gender, Obesity, C-Reactive Protein, and Oxidative Stress
Official title: Gender, Obesity, C-Reactive Protein, and Oxidative Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
Collaborators: name: University of California, Berkeley
name: Kaiser Permanente
First posted: 2004-03-22
Enrollment: 396
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Change in high-sensitivity C-reactive protein (hsCRP)
timeFrame: 8-week intervention
Secondary outcomes:
measure: Change in blood pressure
timeFrame: 8-week intervention
measure: Change in self-reported stress and psychosocial factors
timeFrame: 8-week intervention
measure: Change in oxidative stress biomarkers (F2-Isoprostanes, malondialdehyde)
timeFrame: 8-week intervention
measure: Association of gender, body fat, menopausal status with baseline concentrations of inflammation and oxidative stress biomarkers.
timeFrame: Baseline
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: University of California, Berkeley School of Public Health
state: California
Study officials:
affiliation: University of California at Berkeley
name: Gladys Block, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/j.freeradbiomed.2008.04.005. Epub 2008 Apr 16.
citation: 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. doi: 10.3945/ajcn.111.011460. Epub 2011 Aug 3.