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Effects of Dietary Antioxidants on Cardiovascular Risk Factors

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ClinicalTrials.gov Identifier: NCT00756405
Recruitment Status : Completed
First Posted : September 22, 2008
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Christopher Gardner, Stanford University

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.

Condition or disease Intervention/treatment Phase
Obesity Hyperlipidemia Hypertension Behavioral: Antioxidant diet Dietary Supplement: Antioxidant supplement Dietary Supplement: Placebo Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Potential Health Benefits of Dietary Antioxidants From Supplements v. Foods
Study Start Date : March 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Diet Group
Increased antioxidant diet and placebo pill.
Behavioral: Antioxidant diet
Participants were asked to increase antioxidant-rich food intake to approximately double their daily habitual intake and take a placebo pill.
Dietary Supplement: Placebo
Participants were asked to consume their usual diet and take a placebo pill.
Active Comparator: Supplement Group
Usual diet and antioxidant supplement.
Dietary Supplement: Antioxidant 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.
Placebo Comparator: Placebo
Usual diet and placebo pill.
Dietary Supplement: Placebo
Participants were asked to consume their usual diet and take a placebo pill.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Blood concentrations of antioxidants at baseline and 8 weeks [ Time Frame: Baseline and 8 weeks ]
    Blood concentrations of carotenoids, tocopherols, selenium, and vitamin C (to validate dietary change)

  2. Dietary antioxidants [ Time Frame: Baseline and 8 weeks ]
    Dietary intake of carotenoids, tocopherols, selenium, and vitamin C (as measured by 3-day dietary recalls)



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00756405


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Christopher Gardner
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Christopher D Gardner Stanford University

Additional Information:
Responsible Party: Christopher Gardner, Professor of Medicine (Research), Stanford University
ClinicalTrials.gov Identifier: NCT00756405     History of Changes
Other Study ID Numbers: SU-08202008-1284
1R21AT003245-01 ( U.S. NIH Grant/Contract )
First Posted: September 22, 2008    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christopher Gardner, Stanford University:
Adults
Antioxidants
Inflammatory markers
Diet
Supplements

Additional relevant MeSH terms:
Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs