Obesity Clinical Trial
Official title:
Obesity, Inflammation and Oxidative Stress
The purpose of this study is to determine whether or not Vitamin C (1000 mg/day) can reduce markers of inflammation, especially C-reactive protein (CRP), in obese persons with baseline CRP greater than 1 mg/dl.
The long-term objective of this project is to identify nutritional factors that can reduce
the inflammatory component of obesity. Therapies to minimize obesity-related comorbidities
are needed, and targeting inflammation may help slow the progression of obesity towards
cardiovascular disease and insulin resistance.
Adipose tissue is a source of inflammatory cytokines, and obesity is now viewed as a
chronic, low-grade inflammatory state. Inflammation itself is a contributor to the chronic
diseases associated with obesity. C-reactive protein (CRP) is a key marker of inflammation,
and as a downstream marker it provides functional integration of upstream cytokine
activation associated with inflammation. We have previously shown that vitamin C, but not
vitamin E, reduces CRP in active and passive smokers and in nonsmokers. The reduction is
seen primarily in persons with CRP ≥1.0 mg/L, the CDC threshold for elevated cardiovascular
disease risk. We also found that 75% of obese nonsmokers had CRP ≥1.0 mg/L.
The important observation of reduction in elevated CRP by vitamin C now needs to be
confirmed in a rigorous study with adequate sample size, to permit justifiable conclusions
about the potential usefulness of this agent in reducing inflammation in the obese. We will
conduct a placebo-controlled, randomized trial in 552 healthy obese individuals with
moderate CRP elevations (CRP ≥1.0 mg/L). Participants will be randomized to either 1000
mg/day vitamin C or placebo for a period of 2 months. We will also characterize the pathways
through which this effect takes place by measuring cytokines and oxidative stress.
This project is important because if our previous finding is confirmed in this population,
it could offer a low-cost alternative to use of statins to reduce inflammation in persons
without other risk factors.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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