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

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Obesity
• Intervention / Treatment: Dietary supplement: Grape powder, followed by placebo powder; Dietary supplement: Placebo powder followed by grape powder

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Davis, California, United States, 95616
      • USDA, ARS, Western Human Nutrition Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Dietary supplement: 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.
EXPERIMENTAL: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in inflammatory mediators in serum	C-reactive protein, serum amyloid A, cytokines (IL-1, IL-6, IL-8, and TNF-a), and soluble adhesion molecules (sICAM-1, sVCAM-1) will be measured.	0, 1, 3, 4, 8, and 9 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in lipid particle size and quantity	Lipid particle size will be measured using NMR spectroscopy, inlcuding chylomicrons, six VLDL subpopulations, IDL, three LDL subpopulations, and five HDL subpopulations.	0, 1, 3, 4, 8 and 9 weeks
CHange in activation and proliferation of T lymphocytes	Activation and proliferative responses of T lymphocytes will be measured to determine if grape consumption alters immune cell responsiveness. Proliferative responses will be measured using flow cytometry.	0, 1, 3, 4, 8 and 9 weeks

Collaborators and Investigators

• Sponsor: USDA, Western Human Nutrition Research Center
• Investigators: Principal Investigator: Susan Zunino, PhD, USDA, ARS, Western Human Nutrition Research Center

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (ACTUAL): October 1, 2011
• Study Completion (ACTUAL): October 1, 2011

Study Registration Dates

• First Submitted: September 28, 2011
• First Submitted That Met QC Criteria: September 28, 2011
• First Posted (ESTIMATE): September 30, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): December 12, 2011
• Last Update Submitted That Met QC Criteria: December 8, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Inflammation
• Other Study ID Numbers: 200816801-2