Clinical trial NCT00756405: Effects of Dietary Antioxidants on Cardiovascular Risk Factors
Official title: Potential Health Benefits of Dietary Antioxidants From Supplements v. Foods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Hyperlipidemia
Hypertension
Keywords: Adults
Antioxidants
Inflammatory markers
Diet
Supplements
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2008-09-22
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: 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
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Blood concentrations of antioxidants at baseline and 8 weeks
timeFrame: Baseline and 8 weeks
measure: Dietary antioxidants
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Christopher D Gardner
role: PRINCIPAL_INVESTIGATOR
References:
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.