A Phase 3 interventional study of Vitamin C (ascorbic acid) and Placebo tablet in C-reactive Protein, Inflammation and Obesity, sponsored by University of California, Berkeley. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-02.
Sponsored by University of California, Berkeley · Phase 3, Interventional, and Prevention
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.
6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.
This study's enrollment of 512 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →University of California, Berkeley is the lead sponsor of 106 studies on the registry; 18 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
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Exclusion Criteria:
Two tablets, daily, for 8 weeks
Dietary Supplement: Placebo tablet
Two tablets, daily, for 8 weeks
Dietary Supplement: Vitamin C (ascorbic acid)
1000 mg/day (two 500-mg tablets), 8 weeks
Placebo tablet (two 500-mg tablets), 8 weeks
high-sensitivity C-reactive protein
Time frame: After 8 weeks of intervention
CRP-related markers of inflammation and oxidative stress, including cytokines and F2-isoprostanes.
Time frame: After 8 weeks of intervention.
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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University of California, Berkeley