Clinical trial NCT01443884: Anti-Inflammatory Activities of Grapes in Humans at Risk for Cardiovascular Disease
Official title: Anti-Inflammatory Activities of Grapes in Humans at Risk for Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Inflammation
Lead sponsor: USDA, Western Human Nutrition Research Center
Sponsor class: FED
First posted: 2011-09-30
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of the study is to determine whether grape consumption can reduce the risk of cardiovascular disease by reducing the presence of inflammatory molecules and positively altering cholesterol levels, lipid profiles, and immune cell responses.

Detailed description: Obese individuals are at high risk for the development of hypertension and cardiovascular disease. Adipose tissue is a major source of pro-inflammatory molecules which can promote the development of atherosclerosis. Development of atherosclerotic plaques are mediated by oxidized or otherwise modified LDL cholesterol and infiltration of activated immune cells into the atherosclerotic lesions. Grapes contain high levels of polyphenols, a class of compounds known to possess antioxidant and anti-inflammatory properties. The overall goal of this proposal is to determine whether grape consumption can reduce the risk of cardiovascular disease by reducing the presence of inflammatory molecules and positively altering cholesterol levels, lipid profiles, and immune cell responses. Using a randomized cross-over design, twenty obese subjects will consume beverages containing either four servings of grape powder per day or the caloric equivalent without grape powder (placebo control) for a total of three weeks. After a two week washout period, the beverages will be switched for a further three weeks. Blood will be taken from each person at six intervals to determine lipid profiles, measure inflammatory markers in plasma, and analyze immune cell responsiveness.

Eligibility criteria: Inclusion Criteria:

* BMI 30 - 45 kg/m2
* Commitment to the dietary intervention and scheduled testing

Exclusion Criteria:

* Subjects will be excluded from this study if their blood cell counts or blood chemistry profiles are outside of the normal range
* smoking or use of tobacco products
* drink more than one alcoholic beverage per day (1 oz. distilled liquor, 3 oz. wine, or 12 oz. beer)
* taking cholesterol-lowering medications
* taking steroids for asthma or other inflammatory states
* taking thyroid-regulating drugs
* taking over-the counter weight loss products

Primary outcomes:
measure: Change in inflammatory mediators in serum
timeFrame: 0, 1, 3, 4, 8, and 9 weeks
Secondary outcomes:
measure: Change in lipid particle size and quantity
timeFrame: 0, 1, 3, 4, 8 and 9 weeks
measure: CHange in activation and proliferation of T lymphocytes
timeFrame: 0, 1, 3, 4, 8 and 9 weeks
Other outcomes:
Locations:
city: Davis
country: United States
facility: USDA, ARS, Western Human Nutrition Research Center
state: California
Study officials:
affiliation: USDA, ARS, Western Human Nutrition Research Center
name: Susan Zunino, PhD
role: PRINCIPAL_INVESTIGATOR
References: