Anti-Inflammatory Activities of Grapes in Humans at Risk for Cardiovascular Disease
Primary Purpose
Obesity, Inflammation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Grape powder, followed by placebo powder
Placebo powder followed by grape powder
Sponsored by

About this trial
This is an interventional basic science trial for Obesity
Eligibility 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
Sites / Locations
- USDA, ARS, Western Human Nutrition Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1
Group 2
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT01443884
First Posted
September 28, 2011
Last Updated
December 8, 2011
Sponsor
USDA, Western Human Nutrition Research Center
1. Study Identification
Unique Protocol Identification Number
NCT01443884
Brief Title
Anti-Inflammatory Activities of Grapes in Humans at Risk for Cardiovascular Disease
Official Title
Anti-Inflammatory Activities of Grapes in Humans at Risk for Cardiovascular Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
USDA, Western Human Nutrition Research Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Inflammation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Grape powder, followed by placebo powder
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo powder followed by grape powder
Intervention Description
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 Outcome Measure Information:
Title
Change in inflammatory mediators in serum
Description
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
Secondary Outcome Measure Information:
Title
Change in lipid particle size and quantity
Description
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
Title
CHange in activation and proliferation of T lymphocytes
Description
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.
Time Frame
0, 1, 3, 4, 8 and 9 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Zunino, PhD
Organizational Affiliation
USDA, ARS, Western Human Nutrition Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
USDA, ARS, Western Human Nutrition Research Center
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Anti-Inflammatory Activities of Grapes in Humans at Risk for Cardiovascular Disease
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