Obesity, Hyperlipidemia, Hypertension
Conditions
Keywords
Adults, Antioxidants, Inflammatory markers, Diet, Supplements
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.
Interventions
BEHAVIORALAntioxidant diet
Participants were asked to increase antioxidant-rich food intake to approximately double their daily habitual intake and take a placebo pill.
DIETARY_SUPPLEMENTAntioxidant supplement
Participants were asked to consume their usual diet and take a supplement containing carotenoids, mixed tocopherols, vitamin C and selenium, designed to approximately double their daily habitual intake.
DIETARY_SUPPLEMENTPlacebo
Participants were asked to consume their usual diet and take a placebo pill.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Christopher Gardner
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Overweight/obesity; high LDL cholesterol, pre-hypertension.
Exclusion criteria
1. Daily intake of \> 5 servings of vegetables and fruits 2. Fasting blood glucose \>140 mg/dL 3. BMI \>40 4. 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 6. Pregnant or lactating 7. Inability to communicate effectively with study staff
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline and 8 weeks | Change was calculated as the value at 8 weeks minus the value at baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood concentrations of antioxidants at baseline and 8 weeks | Baseline and 8 weeks | Blood concentrations of carotenoids, tocopherols, selenium, and vitamin C (to validate dietary change) |
| Dietary antioxidants | Baseline and 8 weeks | Dietary intake of carotenoids, tocopherols, selenium, and vitamin C (as measured by 3-day dietary recalls) |
Countries
United States
Outcome results
None listed