Anti-Inflammatory Activities of Grapes in Humans at Risk for Cardiovascular Disease

NCT ID: NCT01443884

Last Updated: 2011-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2011-10-31

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.

Conditions

Obesity; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Group 1

After a 1 week baseline, volunteers will consume two packets of grape powder stirred into water for three weeks. Each packet will contain the equivalent of approximately 2 servings of fresh grapes (46 grams of powder). Following a two week washout period, volunteers will cross-over to a placebo powder.

Group Type: EXPERIMENTAL

Grape powder, followed by placebo powder

Intervention Type: DIETARY_SUPPLEMENT

For three weeks, twice per day, volunteers will consume one packet of freeze-dried grape powder containing the equivalent of approximately 2 servings of fresh grapes (46 grams of powder) stirred into water. Following a two week washout, volunteers will consume one packet of placebo powder twice per day for three weeks.

Group 2

After a 1 week baseline, volunteers will consume two packets of placebo powder stirred into water for three weeks. Following a two week washout period, volunteers will cross-over to grape powder for three weeks.

Group Type: EXPERIMENTAL

Placebo powder followed by grape powder

Intervention Type: DIETARY_SUPPLEMENT

For three weeks, twice per day, volunteers will consume one packet of placebo powder stirred into water. Following a two week washout, volunteers will consume one packet of freeze-dried grape powder containing the equivalent of approximately 2 servings of fresh grapes (46 grams of powder) twice per day for three weeks.

Interventions

Grape powder, followed by placebo powder

For three weeks, twice per day, volunteers will consume one packet of freeze-dried grape powder containing the equivalent of approximately 2 servings of fresh grapes (46 grams of powder) stirred into water. Following a two week washout, volunteers will consume one packet of placebo powder twice per day for three weeks.

Intervention Type: DIETARY_SUPPLEMENT

Placebo powder followed by grape powder

For three weeks, twice per day, volunteers will consume one packet of placebo powder stirred into water. Following a two week washout, volunteers will consume one packet of freeze-dried grape powder containing the equivalent of approximately 2 servings of fresh grapes (46 grams of powder) twice per day for three weeks.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

USDA, Western Human Nutrition Research Center

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Zunino, PhD

Role: PRINCIPAL_INVESTIGATOR

USDA, ARS, Western Human Nutrition Research Center

Locations

USDA, ARS, Western Human Nutrition Research Center

Davis, California, United States

Countries

United States

Other Identifiers

200816801-2

Identifier Type: -

Identifier Source: org_study_id