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Completed

NCT Number: NCT01443884

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.

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USDA, ARS, Western Human Nutrition Research Center

Davis, California, 95616, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Grape powder, followed by placebo powder

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.

Placebo powder followed by grape powder

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

USDA, Western Human Nutrition Research Center

Fed

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 30, 2011
Registry last updated
Dec 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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