ObesityNCT01443884
Anti-Inflammatory Activities of Grapes in Humans at Risk for Cardiovascular Disease
A study of Obesity and Inflammation, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Inflammation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 30 - 45 kg/m2
- Commitment to the dietary intervention and scheduled testing
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA, ARS, Western Human Nutrition Research Center
Davis, California, 95616
About this study
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.
Read the 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.
- Conditions
- Obesity, Inflammation
- Being tested
- Grape powder, followed by placebo powder, Placebo powder followed by grape powder
- Medical subject headings
- Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grape powder, followed by placebo powderDietary 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 powderDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 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. Receives: Dietary Supplement: Grape powder, followed by placebo powder |
| Group 2 | Experimental | 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. Receives: Dietary Supplement: Placebo powder followed by grape powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 1, 3, 4, 8, and 9 weeks
Secondary outcomes (2)
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.
Measured: 0, 1, 3, 4, 8 and 9 weeks
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.
Measured: 0, 1, 3, 4, 8 and 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study startOct 2009
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA, Western Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Susan Zunino, PhD, Principal investigator, USDA, ARS, Western Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443884
- Sponsor's protocol ID
- 200816801-2
- Status last verified
- Dec 2011
- First submitted
- 28 Sep 2011
- Last updated
- 12 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Inflammatory Activities of Grapes in Humans at Risk for Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT01443884
- Acronym / sponsor ID
- 200816801-2
- Conditions
- Obesity, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- USDA, Western Human Nutrition Research CenterUS federal agency
- Study start
- Oct 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 30 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Dietary Supplement: Grape powder, followed by placebo powderAfter 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. |
| Group 2 | Experimental | Dietary Supplement: Placebo powder followed by grape powderAfter 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI 30 - 45 kg/m2
- Commitment to the dietary intervention and scheduled testing
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grape powder, followed by placebo powderFor 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. | Dietary supplement | Group 1 |
| Placebo powder followed by grape powderFor 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. | Dietary supplement | Group 2 |
Primary outcome
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.
2 secondary outcomes
Change in lipid particle size and quantity
Time frame: 0, 1, 3, 4, 8 and 9 weeks
CHange in activation and proliferation of T lymphocytes
Time frame: 0, 1, 3, 4, 8 and 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2011.
- USDA Western Human Nutrition Research CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Zunino, PhD principal investigator
USDA, ARS, Western Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Obesity and Inflammation, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in inflammatory mediators in serum (time frame: 0, 1, 3, 4, 8, and 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2011.