Obesity, Inflammation and Oxidative Stress
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
C-reactive Protein Inflammation Obesity Oxidative Stress |
Dietary Supplement: Vitamin C (ascorbic acid) |
Phase 3 |
| 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: | Obesity, Inflammation and Oxidative Stress |
- high-sensitivity C-reactive protein [ Time Frame: After 8 weeks of intervention ] [ Designated as safety issue: No ]
- CRP-related markers of inflammation and oxidative stress, including cytokines and F2-isoprostanes. [ Time Frame: After 8 weeks of intervention. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 552 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Two tablets, daily, for 8 weeks
|
Dietary Supplement: Vitamin C (ascorbic acid)
1000 mg/day (two 500-mg tablets), 8 weeks
|
| Experimental: Vitamin C |
Dietary Supplement: Vitamin C (ascorbic acid)
1000 mg/day (two 500-mg tablets), 8 weeks
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- BMI ≥ 30
- hsCRP ≥ 1 mg/L
- Age 18+
- Member of Kaiser Permanente Health Plan of Northern California
Exclusion Criteria:
- Smoker
- Unwilling to discontinue vitamin supplements for study duration
- Unwilling/unable to use acetaminophen in place of OTC anti-inflammatory medications
- Use of certain medications
- History of certain medical conditions
Contacts and Locations| Contact: Christopher D. Jensen, PhD | 510-891-3665 | Christopher.D.Jensen@nsmtp.kp.org |
| Contact: Eva R. Greenstein | 510-891-5918 | Eva.R.Greenstein@kp.org |
| United States, California | |
| Kaiser Permanente of Northern California, Division of Research | Recruiting |
| Oakland, California, United States, 94612 | |
| Contact: Jensen | |
| Contact: Greenstein | |
| Principal Investigator: Douglas Corley, MD, PhD | |
| Principal Investigator: | Gladys Block, PhD | University of California, Berkeley |
More Information
Publications:
| Responsible Party: | Gladys Block, University of California, Berkeley |
| ClinicalTrials.gov Identifier: | NCT01028976 History of Changes |
| Other Study ID Numbers: | DK062378-05 |
| Study First Received: | December 8, 2009 |
| Last Updated: | June 16, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Berkeley:
|
randomized controlled trial primary prevention Vitamin C Antioxidants |
C-reactive protein inflammation anti-inflammatory agents obesity |
Additional relevant MeSH terms:
|
Inflammation Obesity Pathologic Processes Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Anti-Inflammatory Agents Ascorbic Acid |
Vitamins Therapeutic Uses Pharmacologic Actions Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 16, 2013