Effects of Dietary Antioxidants on Cardiovascular Risk Factors

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00756405
First received: September 19, 2008
Last updated: April 29, 2010
Last verified: April 2010
  Purpose

The aim of the Antioxidant Study is 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 Intervention
Obesity
Hyperlipidemia
Insulin Resistance
Hypertension
Behavioral: Antioxidants from supplements vs foods

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: Potential Health Benefits of Dietary Antioxidants From Supplements v. Foods

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Inflammatory Markers [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood Lipids [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Blood Pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: March 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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 will be asked to consume an antioxidant supplement that may or may not include Vitamin E, Vitamin C, Beta-carotene, 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's (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 will be 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756405

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Christopher D Gardner Stanford University
  More Information

No publications provided

Responsible Party: Christopher D Gardner, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00756405     History of Changes
Other Study ID Numbers: SU-08202008-1284, 7116
Study First Received: September 19, 2008
Last Updated: April 29, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hyperlipidemias
Hypertension
Insulin Resistance
Cardiovascular Diseases
Dyslipidemias
Glucose Metabolism Disorders
Hyperinsulinism
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on October 29, 2014