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
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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 |
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 |
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.
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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.
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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.
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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.
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- 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.
- 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.
- 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.

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Ages Eligible for Study: | 20 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
United States, California | |
USDA, ARS, Western Human Nutrition Research Center | |
Davis, California, United States, 95616 |
Principal Investigator: | Susan Zunino, PhD | USDA, ARS, Western Human Nutrition Research Center |
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 |