Effects of Dietary Antioxidants on Cardiovascular Risk Factors

NCT00756405 | Completed

• 2 other identifiers: SU-08202008-12841R21AT003245-01
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Hyperlipidemia; Hypertension

Keywords

Adults; Antioxidants; Inflammatory markers; Diet; Supplements

Outcome Measures

Primary Outcomes (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

  Change was calculated as the value at 8 weeks minus the value at baseline

  Baseline and 8 weeks

Secondary Outcomes (2)

• Blood concentrations of antioxidants at baseline and 8 weeks

  Baseline and 8 weeks

• Dietary antioxidants

  Baseline and 8 weeks

Study Arms (3)

Diet Group

ACTIVE COMPARATOR

Increased antioxidant diet and placebo pill.

Behavioral: Antioxidant diet; Dietary Supplement: Placebo

Supplement Group

ACTIVE COMPARATOR

Usual diet and antioxidant supplement.

Dietary Supplement: Antioxidant supplement

Placebo

PLACEBO COMPARATOR

Usual diet and placebo pill.

Dietary Supplement: Placebo

Interventions

Antioxidant diet BEHAVIORAL

Participants were asked to increase antioxidant-rich food intake to approximately double their daily habitual intake and take a placebo pill.

Diet Group

Antioxidant supplement DIETARY_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.

Supplement Group

Placebo DIETARY_SUPPLEMENT

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

Diet Group; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Christopher Gardner: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related 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.

  PMID: 29540273 BACKGROUND

Related Links

• Study description and results.

MeSH Terms

Conditions

Obesity; Hyperlipidemias; Hypertension

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Christopher D Gardner

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine (Research)

Study Record Dates

• First Submitted: September 19, 2008
• First Posted: September 22, 2008
• Study Start: March 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)