ObesityNCT01775748
Effect of Concord Grape Juice on Endothelial Function
A study testing Active Concord Grape Juice 12 oz per day in people with Obesity and Overweight, run by Boston University at 1 site in United States.
Trial summary
The study will compare Concord grape juice to a beverage that contains no grape flavonoids, but has a similar appearance and taste (placebo juice). A total of 60 overweight and obese participants over age 50 will be enrolled. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Active Concord Grape Juice 12 oz per day
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2013to 19 Mar 2014
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index ≥ 25 and < 40 kg/m2
- Age ≥ 50 years
- Otherwise healthy
Who cannot join
- Clinical diagnosis of atherosclerotic vascular disease.
- Clinical history of diabetes mellitus or fasting glucose ≥126 mg/dl
- Uncontrolled hypertension
- Treatment with an investigational new drug within the last 30 days
- Clinical history of other major illness including end-stage cancer, renal failure, hepatic failure, or other conditions that in the opinion of the principal investigator make the study inappropriate
- Psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study
- Use of Vitamin E, Vitamin C, beta carotene, lipoic acid, or other food or herbal supplements within 1 month of enrollment. Subjects taking multivitamins or other forms of vitamin E and C in doses that do not exceed two times the recommended daily allowance will not be excluded
- Extreme dietary habits (i.e. Atkins, very high protein/low carbohydrate, or vegan diet
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University School of Medicine
Boston, Massachusetts, 02118
About this study
Official title: Effect Of Concord Grape Juice On Endothelial Function In Obese And Overweight Individuals Over Age 50
The study will compare Concord grape juice to a beverage that contains no grape flavonoids, but has a similar appearance and taste (placebo juice). A total of 60 overweight and obese participants over age 50 will be enrolled. Each participant will drink each beverage for 4 weeks with a 2-week rest period between two beverage consumption periods. The order of beverages (grape juice first or placebo juice first) will be randomized. The investigators will use ultrasound to measure brachial artery flow-mediated dilation, a measure of endothelial vasodilator function. The investigators will also collect blood samples to further assess the cardiovascular effects of grape juice.
The aim of the study is to determine whether Concord grape juice improves endothelial function in patients at risk who do not have cardiovascular disease and may provide information that would guide dietary recommendations. The results may also be used by the sponsor to substantiate claims and labeling of their product.
- Conditions
- Obesity, Overweight
- Being tested
- Active Concord Grape Juice 12 oz per day, Placebo Grape Juice 12 oz per day
- Keywords
- Grape juice
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Concord Grape Juice 12 oz per dayOther
Grape Juice 12 oz per day
Placebo Grape Juice 12 oz per dayOther
Placebo Grape Juice 12 oz per day
| Study group | Role | What they receive |
|---|---|---|
| Active First | Other | Active Concord Grape Juice 12 oz per day Placebo Grape Juice 12 oz per day Receives: Other: Active Concord Grape Juice 12 oz per day; Other: Placebo Grape Juice 12 oz per day |
| Placebo First | Other | Placebo Grape Juice 12 oz per day Active Concord Grape Juice 12 oz per day Receives: Other: Active Concord Grape Juice 12 oz per day; Other: Placebo Grape Juice 12 oz per day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial artery flow mediated dilation
Endothelial function will be assessed as brachial artery flow-mediated dilation using vascular ultrasound
Measured: 4 weeks
Secondary outcomes (3)
Nitroglycerin-mediated dilation
Non-endothelium-dependent dilation will be assessed by measuring the dilator response to sublingual nitroglycerin using vascular ultrasound
Measured: 4 weeks
Carotid-Femoral Pulse Wave Velocity
Central aortic stiffness will be assessed as carotid-femoral pulse wave velocity using applanation tonometry
Measured: 4 weeks
Reactive hyperemia
We will use vascular ultrasound to determine maximal hyperemic flow velocity in the brachial artery induced by 4-minute cuff occlusion.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2013 (estimated)
- Study start1 Jan 2013
- Primary completion19 Mar 2014
- Study completion19 Mar 2014
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.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Welch's, Inc.
- Responsible party
- Sponsor
- Investigators
- Robert E Eberhardt, MD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01775748
- Sponsor's protocol ID
- H-31937
- Status last verified
- Feb 2018
- First submitted
- 23 Jan 2013
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Concord Grape Juice On Endothelial Function In Obese And Overweight Individuals Over Age 50
- ClinicalTrials.gov ID
- NCT01775748
- Acronym / sponsor ID
- H-31937
- Conditions
- Obesity, Overweight
- Keywords
- Grape juice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Welch's, Inc.
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 19 Mar 2014 (actual)
- Study completion
- 19 Mar 2014 (actual)
- First posted
- 25 Jan 2013 (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 study will compare Concord grape juice to a beverage that contains no grape flavonoids, but has a similar appearance and taste (placebo juice). A total of 60 overweight and obese participants over age 50 will be enrolled. Each participant will drink each beverage for 4 weeks with a 2-week rest period between two beverage consumption periods. The order of beverages (grape juice first or placebo juice first) will be randomized. The investigators will use ultrasound to measure brachial artery flow-mediated dilation, a measure of endothelial vasodilator function. The investigators will also collect blood samples to further assess the cardiovascular effects of grape juice.
The aim of the study is to determine whether Concord grape juice improves endothelial function in patients at risk who do not have cardiovascular disease and may provide information that would guide dietary recommendations. The results may also be used by the sponsor to substantiate claims and labeling of their product.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active First | Other | Other: Active Concord Grape Juice 12 oz per day, Other: Placebo Grape Juice 12 oz per dayActive Concord Grape Juice 12 oz per day Placebo Grape Juice 12 oz per day |
| Placebo First | Other | Other: Active Concord Grape Juice 12 oz per day, Other: Placebo Grape Juice 12 oz per dayPlacebo Grape Juice 12 oz per day Active Concord Grape Juice 12 oz per day |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index ≥ 25 and < 40 kg/m2
- Age ≥ 50 years
- Otherwise healthy
Key exclusion criteria (8 listed)
- Clinical diagnosis of atherosclerotic vascular disease.
- Clinical history of diabetes mellitus or fasting glucose ≥126 mg/dl
- Uncontrolled hypertension
- Treatment with an investigational new drug within the last 30 days
- Clinical history of other major illness including end-stage cancer, renal failure, hepatic failure, or other conditions that in the opinion of the principal investigator make the study inappropriate
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 |
|---|---|---|
| Active Concord Grape Juice 12 oz per dayGrape Juice 12 oz per day | Other | Active First, Placebo First |
| Placebo Grape Juice 12 oz per dayPlacebo Grape Juice 12 oz per day | Other | Active First, Placebo First |
Primary outcome
Brachial artery flow mediated dilation
Time frame: 4 weeks
Endothelial function will be assessed as brachial artery flow-mediated dilation using vascular ultrasound
3 secondary outcomes
Nitroglycerin-mediated dilation
Time frame: 4 weeks
Carotid-Femoral Pulse Wave Velocity
Time frame: 4 weeks
Reactive hyperemia
Time frame: 4 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 Feb 2018.
- 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.
Robert E Eberhardt, MD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Concord Grape Juice 12 oz per day in people with Obesity and Overweight, run by Boston University 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 3 inclusion and 8 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 Feb 2018. 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?
Brachial artery flow mediated dilation (time frame: 4 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 Feb 2018.