Metabolic SyndromeGSEMetSNCT01190358
Grape Seed Extract and Postprandial Oxidation and Inflammation
A study testing Grape seed extract in people with Metabolic Syndrome, run by University of California, Davis at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether taking grape seed extract prior to eating a high fat meal will reduce the inflammatory response in people with the metabolic syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Grape seed extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2010to Sep 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The metabolic syndrome will be diagnosed on the basis of having a combination of any 3 of the following factors:
- Waist circumference of ≥ 40 inches (men) or ≥ 35 inches (women)
- Elevated triglycerides ≥150mg/dl
- HDL cholesterol of < 40mg/dl (men) or < 50mg/dl (women)
- Elevated blood pressure of ≥ 130/85mmHg
- Fasting glucose of > 100mg/dL
Who cannot join
- Smokers
- Female subjects who are pregnant or lactating
- Subjects taking any medications that would interfere with outcomes of the study i.e. lipid lowering medications, anti-inflammatory drugs (i.e. ibuprofen), dietary supplements
- Subjects with any known allergy or intolerance to foods involved in the study (cantaloupe, egg, dairy, wheat, grape seed extract)
- Subjects who are actively trying to lose weight
- Subjects with unusual dietary habits (i.e. pica, anorexia nervosa, extreme food restriction, binging and/or purging disorders)
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- Subjects who are addicted to drugs or alcohol or who are <1 year recovery program
- Subjects who present with significant psychiatric or neurological disturbances as determined by the primary investigator (i.e. uncontrolled bipolar disorder)
- Subjects with documented atherosclerotic disease, inflammatory disease, diabetes mellitus, uncontrolled hypertension (≥ 140/90mmHg), liver and kidney disease as identified by routine blood tests (chemistry panels). These subjects will be referred to their primary care doctor for further care.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California Davis (Academic Surge, Ragle Human Nutrition Research Facility)
Davis, California, 95616
VA Hospital, Mather
Mather, California, 95655
About this study
Official title: Grape Seed Extract and Postprandial Oxidation and Inflammation: A Pilot Study in People With the Metabolic Syndrome.
The purpose of this study is to determine whether taking grape seed extract prior to eating a high fat meal will reduce the inflammatory response in people with the metabolic syndrome.
Read the detailed description
The purpose of this study is to determine whether taking grape seed extract prior to eating a high fat meal will reduce the inflammatory response in people with the metabolic syndrome. If this extract is shown to mitigate the inflammatory response induced by a high fat meal, it could potentially aid in postponing of the diagnosis of diabetes or other chronic diseases associated with high levels of inflammation.
- Conditions
- Metabolic Syndrome
- Being tested
- Placebo, Grape seed extract
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Also called Placebo, non-active components
Sugar pill containing maltodextrin.
Grape seed extractDietary supplement
Also called Active, Meganatural Gold®
Meganatural Gold® contains 300mg of grape seed extract.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Sugar pill Receives: Dietary Supplement: Placebo |
| Grape seed extract | Active comparator | 300mg of grape seed extract. Receives: Dietary Supplement: Grape seed extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modification of the postprandial inflammatory response.
Analysis of inflammatory markers known to increase following a meal high in fat (~40% kcal from fat). Markers to be analyzed will include the following:
- Serum lipids
- Oxidized LDL
- Hs-CRP
- TNFα
- IL1
- IL6
Measured: 7 hours
Secondary outcomes (1)
Metabolic response to a high fat meal.
Assay for the insulin and glucose response generated from consumming a high fat meal (~40% of kcal from fat).
Measured: 7 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionMar 2011
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chulani T Kappagoda, M.D., Ph. D., Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01190358
- Sponsor's protocol ID
- 200917488
- Acronym
- GSEMetS
- Status last verified
- Jul 2017
- First submitted
- 25 Aug 2010
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Grape Seed Extract and Postprandial Oxidation and Inflammation: A Pilot Study in People With the Metabolic Syndrome.
- ClinicalTrials.gov ID
- NCT01190358
- Acronym / sponsor ID
- GSEMetS / 200917488
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Aug 2010 (actual)
- Primary completion
- Mar 2011 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 27 Aug 2010 (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 purpose of this study is to determine whether taking grape seed extract prior to eating a high fat meal will reduce the inflammatory response in people with the metabolic syndrome.
Detailed description
The purpose of this study is to determine whether taking grape seed extract prior to eating a high fat meal will reduce the inflammatory response in people with the metabolic syndrome. If this extract is shown to mitigate the inflammatory response induced by a high fat meal, it could potentially aid in postponing of the diagnosis of diabetes or other chronic diseases associated with high levels of inflammation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSugar pill |
| Grape seed extract | Active comparator | Dietary Supplement: Grape seed extract300mg of grape seed extract. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The metabolic syndrome will be diagnosed on the basis of having a combination of any 3 of the following factors:
- Waist circumference of ≥ 40 inches (men) or ≥ 35 inches (women)
- Elevated triglycerides ≥150mg/dl
- HDL cholesterol of < 40mg/dl (men) or < 50mg/dl (women)
- Elevated blood pressure of ≥ 130/85mmHg
Key exclusion criteria (9 listed)
- Smokers
- Female subjects who are pregnant or lactating
- Subjects taking any medications that would interfere with outcomes of the study i.e. lipid lowering medications, anti-inflammatory drugs (i.e. ibuprofen), dietary supplements
- Subjects with any known allergy or intolerance to foods involved in the study (cantaloupe, egg, dairy, wheat, grape seed extract)
- Subjects who are actively trying to lose weight
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 |
|---|---|---|
| PlaceboAlso: Placebo, non-active componentsSugar pill containing maltodextrin. | Dietary supplement | Placebo |
| Grape seed extractAlso: Active, Meganatural Gold®Meganatural Gold® contains 300mg of grape seed extract. | Dietary supplement | Grape seed extract |
Primary outcome
Modification of the postprandial inflammatory response.
Time frame: 7 hours
Analysis of inflammatory markers known to increase following a meal high in fat (~40% kcal from fat). Markers to be analyzed will include the following: 1. Serum lipids 2. Oxidized LDL 3. Hs-CRP 4. TNFα 5. IL1 6. IL6
1 secondary outcome
Metabolic response to a high fat meal.
Time frame: 7 hours
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 19 Jul 2017.
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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.
Chulani T Kappagoda, M.D., Ph. D. principal investigator
University of California, Davis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grape seed extract in people with Metabolic Syndrome, run by University of California, Davis at 2 sites 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 6 inclusion and 9 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 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Modification of the postprandial inflammatory response. (time frame: 7 hours). 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 19 Jul 2017.