Healthy VolunteersNCT01751750
Grape Polyphenol Kinetics in Humans
A study testing Grape in people with Healthy Volunteers, run by Janet Novotny at 1 site in United States.
Trial summary
The objectives of this study are the following: 1) to confirm that the administration of grape juice, resveratrol, and grape seed polyphenol extract results in a similar plasma and urinary metabolic profile in aged humans compared to rats, 2) to confirm that a combined administration of grape juice, resveratrol, and… Read more about this study
- Who is it for?
- Ages Up to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Grape
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Sep 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 Up to 59 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- -
Who cannot join
- Age <60 years at beginning of study
- Fasting glucose > 126 mg/dl
- Blood pressure > 160/100
- Fasting total blood cholesterol > 280 mg/dl
- Fasting triglycerides > 300 mg/dl
- Presence of kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes
Show all 17Show fewer
- Presence of type 2 diabetes requiring the use of oral antidiabetic agents or insulin
- History of bariatric or certain other surgeries related to weight control
- Smokers or other tobacco users (during 6 months prior to the start of the study)
- Consumption of more than 3 servings of tea, wine, or grape juice per day
- Use of supplements containing grape extracts or products
- Use of antibiotics during the intervention or for 3 weeks prior to the intervention period
- History of eating disorders, dietary patterns, or supplement use which will interfere with the goal of the intervention
- Volunteers who have lost 10% of body weight within the last 4 months
- Volunteers who are unable or unwilling to give informed consent or communicate with study staff
- Volunteers who self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
- Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA Beltsville Human Nutrition Research Center
Beltsville, Maryland, 20705
About this study
The objectives of this study are the following: 1) to confirm that the administration of grape juice, resveratrol, and grape seed polyphenol extract results in a similar plasma and urinary metabolic profile in aged humans compared to rats, 2) to confirm that a combined administration of grape juice, resveratrol, and grape seed polyphenol extract result in a similar plasma and urinary metabolic profile in adults with tendencies toward metabolic syndrome compared to non-obese healthy humans, and 3) to identify the anti-inflammatory effects of the combined administration of grape juice, resveratrol, and grape seed polyphenol extract.
- Conditions
- Healthy Volunteers
- Being tested
- Grape
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GrapeOther
16 oz. of Concord grape juice (8 oz. consumed 2 times per day; total dose of approximately 1.2 g phenolic compounds per day), 250 mg resveratrol provided as a capsule (commercially available supplement; 125 mg consumed 2 times per day), and 1 g grape seed polyphenol extract provided as a capsule (commercially available supplement; 0.5 g consumed 2 times per day).
| Study group | Role | What they receive |
|---|---|---|
| Grape | Other | Not described Receives: Other: Grape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma polyphenols
Blood will be analyzed for polyphenols and polyphenol metabolites.
Measured: 6 hours
Urinary polyphenols
Urine will be analyzed for polyphenols and polyphenol metabolites.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2012 (estimated)
- Study startSep 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janet Novotny
- Sponsor type
- US federal agency
- Responsible party
- Sponsor-investigator, Janet Novotny, USDA Beltsville Human Nutrition Research Center
- Investigators
- Janet Novotny, Ph.D., Principal investigator, USDA Beltsville Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751750
- Sponsor's protocol ID
- HS38
- Status last verified
- May 2017
- First submitted
- 10 Dec 2012
- Last updated
- 25 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Novotny JA, Chen TY, Terekhov AI, Gebauer SK, Baer DJ, Ho L, Pasinetti GM, Ferruzzi MG. The effect of obesity and repeated exposure on pharmacokinetic response to grape polyphenols in humans. Mol Nutr Food Res. 2017 Nov;61(11):10.1002/mnfr.201700043. doi: 10.1002/mnfr.201700043. Epub 2017 Aug 29.
PubMed 28654207
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Grape Polyphenol Kinetics in Humans
- ClinicalTrials.gov ID
- NCT01751750
- Acronym / sponsor ID
- HS38
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Janet NovotnyUS federal agency
- Study start
- Sep 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 18 Dec 2012 (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 objectives of this study are the following: 1) to confirm that the administration of grape juice, resveratrol, and grape seed polyphenol extract results in a similar plasma and urinary metabolic profile in aged humans compared to rats, 2) to confirm that a combined administration of grape juice, resveratrol, and grape seed polyphenol extract result in a similar plasma and urinary metabolic profile in adults with tendencies toward metabolic syndrome compared to non-obese healthy humans, and 3) to identify the anti-inflammatory effects of the combined administration of grape juice, resveratrol, and grape seed polyphenol extract.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Grape | Other | Other: Grape |
Who may qualify
- Ages
- Up to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (17 listed)
- Age <60 years at beginning of study
- Fasting glucose > 126 mg/dl
- Blood pressure > 160/100
- Fasting total blood cholesterol > 280 mg/dl
- Fasting triglycerides > 300 mg/dl
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 |
|---|---|---|
| Grape16 oz. of Concord grape juice (8 oz. consumed 2 times per day; total dose of approximately 1.2 g phenolic compounds per day), 250 mg resveratrol provided as a capsule (commercially available supplement; 125 mg consumed 2 times per day), and 1 g grape seed polyphenol extract provided as a capsule (commercially available supplement; 0.5 g consumed 2 times per day). | Other | Grape |
Primary outcome
Plasma polyphenols
Time frame: 6 hours
Blood will be analyzed for polyphenols and polyphenol metabolites.
Urinary polyphenols
Time frame: 6 hours
Urine will be analyzed for polyphenols and polyphenol metabolites.
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 25 May 2017.
- Derived from this study: PubMed 28654207Novotny JA, Chen TY, Terekhov AI, Gebauer SK, Baer DJ, Ho L, Pasinetti GM, Ferruzzi MG. The effect of obesity and repeated exposure on pharmacokinetic response to grape polyphenols in humans. Mol Nutr Food Res. 2017 Nov;61(11):10.1002/mnfr.201700043. doi: 10.1002/mnfr.201700043. Epub 2017 Aug 29.
- Individual participant dataSharing planned: No
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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.
Janet Novotny, Ph.D. principal investigator
USDA Beltsville 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 testing Grape in people with Healthy Volunteers, run by Janet Novotny 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 1 inclusion and 17 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 25 May 2017. 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?
Plasma polyphenols (time frame: 6 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01751750, which also lists 1 linked publication.
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 25 May 2017.