USDA, ARS, Western Human Nutrition Research Center
Davis, California, 95616, United States
NCT Number: NCT01443884
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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Notify Me20 year–60 year
All sexes
Interventional
Not applicable
Davis, California, 95616, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
USDA, Western Human Nutrition Research Center
Fed
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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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