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Effects of Dietary Antioxidants on Cardiovascular Risk Factors

Primary Purpose

Obesity, Hyperlipidemia, Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Antioxidant diet
Antioxidant supplement
Placebo
Sponsored by
Christopher Gardner
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Adults, Antioxidants, Inflammatory markers, Diet, Supplements

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Diet Group

Supplement Group

Placebo

Arm Description

Increased antioxidant diet and placebo pill.

Usual diet and antioxidant supplement.

Usual diet and placebo pill.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Blood concentrations of antioxidants at baseline and 8 weeks
Blood concentrations of carotenoids, tocopherols, selenium, and vitamin C (to validate dietary change)
Dietary antioxidants
Dietary intake of carotenoids, tocopherols, selenium, and vitamin C (as measured by 3-day dietary recalls)

Full Information

First Posted
September 19, 2008
Last Updated
February 18, 2023
Sponsor
Christopher Gardner
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00756405
Brief Title
Effects of Dietary Antioxidants on Cardiovascular Risk Factors
Official Title
Potential Health Benefits of Dietary Antioxidants From Supplements v. Foods
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Christopher Gardner
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Hyperlipidemia, Hypertension
Keywords
Adults, Antioxidants, Inflammatory markers, Diet, Supplements

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diet Group
Arm Type
Active Comparator
Arm Description
Increased antioxidant diet and placebo pill.
Arm Title
Supplement Group
Arm Type
Active Comparator
Arm Description
Usual diet and antioxidant supplement.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Usual diet and placebo pill.
Intervention Type
Behavioral
Intervention Name(s)
Antioxidant diet
Intervention Description
Participants were asked to increase antioxidant-rich food intake to approximately double their daily habitual intake and take a placebo pill.
Intervention Type
Dietary Supplement
Intervention Name(s)
Antioxidant supplement
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Participants were asked to consume their usual diet and take a placebo pill.
Primary Outcome Measure Information:
Title
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
Description
Change was calculated as the value at 8 weeks minus the value at baseline
Time Frame
Baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Blood concentrations of antioxidants at baseline and 8 weeks
Description
Blood concentrations of carotenoids, tocopherols, selenium, and vitamin C (to validate dietary change)
Time Frame
Baseline and 8 weeks
Title
Dietary antioxidants
Description
Dietary intake of carotenoids, tocopherols, selenium, and vitamin C (as measured by 3-day dietary recalls)
Time Frame
Baseline and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher D Gardner
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29540273
Citation
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.
Results Reference
background
Links:
URL
https://med.stanford.edu/nutrition/research/completed-studies/dietary-antioxidants.html
Description
Study description and results.

Learn more about this trial

Effects of Dietary Antioxidants on Cardiovascular Risk Factors

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