Effects of Dietary Antioxidants on Cardiovascular Risk Factors

Obesity Clinical Trial

Official title:

Potential Health Benefits of Dietary Antioxidants From Supplements v. Foods

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00756405
• Other study ID #: SU-08202008-1284
• Secondary ID: 1R21AT003245-01
• Status: Completed
• Phase: N/A
• Start date: March 2007
• Est. completion date: December 2008

Study information

• Verified date: February 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Hypertension
• Obesity

Intervention

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:
• 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
Participants were asked to consume their usual diet and take a placebo pill.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Christopher Gardner	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Dewell A, Tsao P, Rigdon J, Gardner CD. Antioxidants from diet or supplements do not alter inflammatory markers in adults with cardiovascular disease risk. A pilot randomized controlled trial. Nutr Res. 2018 Feb;50:63-72. doi: 10.1016/j.nutres.2017.10.017. Epub 2017 Nov 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change was calculated as the value at 8 weeks minus the value at baseline	Baseline and 8 weeks
Secondary	Blood concentrations of antioxidants at baseline and 8 weeks	Blood concentrations of carotenoids, tocopherols, selenium, and vitamin C (to validate dietary change)	Baseline and 8 weeks
Secondary	Dietary antioxidants	Dietary intake of carotenoids, tocopherols, selenium, and vitamin C (as measured by 3-day dietary recalls)	Baseline and 8 weeks

External Links

•   Study description and results.