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

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ClinicalTrials.gov Identifier: NCT01443884
Recruitment Status : Completed
First Posted : September 30, 2011
Last Update Posted : December 12, 2011
Sponsor:
Information provided by (Responsible Party):
USDA, Western Human Nutrition Research Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity Inflammation Dietary Supplement: Grape powder, followed by placebo powder Dietary Supplement: Placebo powder followed by grape powder Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Anti-Inflammatory Activities of Grapes in Humans at Risk for Cardiovascular Disease
Study Start Date : October 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in inflammatory mediators in serum [ Time Frame: 0, 1, 3, 4, 8, and 9 weeks ]
    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.


Secondary Outcome Measures :
  1. Change in lipid particle size and quantity [ Time Frame: 0, 1, 3, 4, 8 and 9 weeks ]
    Lipid particle size will be measured using NMR spectroscopy, inlcuding chylomicrons, six VLDL subpopulations, IDL, three LDL subpopulations, and five HDL subpopulations.

  2. CHange in activation and proliferation of T lymphocytes [ Time Frame: 0, 1, 3, 4, 8 and 9 weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01443884


Locations
United States, California
USDA, ARS, Western Human Nutrition Research Center
Davis, California, United States, 95616
Sponsors and Collaborators
USDA, Western Human Nutrition Research Center
Investigators
Principal Investigator: Susan Zunino, PhD USDA, ARS, Western Human Nutrition Research Center
More Information
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Responsible Party: USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01443884     History of Changes
Other Study ID Numbers: 200816801-2
First Posted: September 30, 2011    Key Record Dates
Last Update Posted: December 12, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Inflammation
Cardiovascular Diseases
Pathologic Processes
Anti-Inflammatory Agents