Potential Health Benefits of Dietary Antioxidants From Supplements v. Foods
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- Change from baseline in inflammatory Markers [monocyte chemotactic protein-1 (MCP-1), interleukin-6 (IL-6), and soluble intercellular adhesion molecule-1 (sICAM-1)] at 8 weeks
Study Overview
Brief Summary
The aim of the Antioxidant Study was to compare the efficacy of foods naturally rich in antioxidants with that of antioxidants in a pill form on markers of inflammation and plasma cholesterol in healthy adults at risk of cardiovascular disease.
Detailed Description
Increasing the amount of antioxidants in your diet is thought to be one way to improve your health. If antioxidants do have a beneficial effect, one way to measure that is to examine possible changes in the levels of inflammatory markers in your blood.
Participants were asked to consume an antioxidant supplement including carotenoids, mixed tocopherols, vitamin C and selenium, or a placebo for 8 weeks. The doses of antioxidants will be similar to the amounts suggested by the United States Department of Agriculture (USDA) recommended daily allowances (RDA). In addition, a group of participants will be asked to change their usual eating habits and consume more of certain foods that are naturally good sources of the four antioxidants contained in the pills.
Eligible participants were asked to come to the Stanford Campus for 3 fasting blood draws over the period of 8 weeks and to complete diet and physical activity questionnaires at the beginning, middle, and end of the study period.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Overweight/obesity; high LDL cholesterol, pre-hypertension.
Exclusion Criteria
- •Daily intake of > 5 servings of vegetables and fruits
- •Fasting blood glucose >140 mg/dL
- •Liver or renal disease; Atherosclerosis (e.g., CAD, PAD); Malignant neoplasm; Ongoing infection; Inflammatory disease 5.Currently taking the following medications: Anti-inflammatory drugs Lipid lowering drugs Anti-hypertensive drugs Calcium containing drugs Drugs known to affect blood coagulation Drugs known to affect antioxidant status
- •Pregnant or lactating
- •Inability to communicate effectively with study staff
Arms & Interventions
Diet Group
Increased antioxidant diet and placebo pill.
Intervention: Antioxidant diet (Behavioral)
Diet Group
Increased antioxidant diet and placebo pill.
Intervention: Placebo (Dietary Supplement)
Supplement Group
Usual diet and antioxidant supplement.
Intervention: Antioxidant supplement (Dietary Supplement)
Placebo
Usual diet and placebo pill.
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Change from baseline in inflammatory Markers [monocyte chemotactic protein-1 (MCP-1), interleukin-6 (IL-6), and soluble intercellular adhesion molecule-1 (sICAM-1)] at 8 weeks
Time Frame: Baseline and 8 weeks
Change was calculated as the value at 8 weeks minus the value at baseline
Secondary Outcomes
- Dietary antioxidants(Baseline and 8 weeks)
- Blood concentrations of antioxidants at baseline and 8 weeks(Baseline and 8 weeks)
Investigators
Christopher Gardner
Professor of Medicine (Research)
Stanford University