Glycemic ResponseNCT03409497
Effects of Grape Juice With Breakfast on Glycemia and Cognitive Function in Healthy Adults
A study testing Concord Grape Juice, Low flavonoid low essence beverage and Low flavonoid beverage in people with Glycemic Response and Appetitive Behavior, run by Purdue University at 1 site in United States.
Trial summary
Assess the impact of 100% grape juice with a meal on postprandial glycemic response and subsequent appetite, food intake and cognitive function. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycemic Response, Appetitive Behavior
- What is being tested?
- Concord Grape Juice, Low flavonoid low essence beverage and Low flavonoid beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2019to 30 Jun 2020
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 25.0-34.9 kg/m2
- Willingness to eat all test foods
- Low consumer of tea and coffee, willingness to refrain from both during the 48 hours prior to test days and on the test day
- Fasting blood glucose below 6.1mmol/l via capillary finger-stick blood sample using a SureStep glucometer (Lifescan, Milpitas, CA)
Who cannot join
- Taking medications known to affect glycemia, lipid metabolism or appetite
- Body weight fluctuation of >5kg in the past 3 months
- Taking vitamin or other supplements
- Smokers
- Acute or Chronic disease
Trial locations and contacts
1 site in 1 country.
About this study
Assess the impact of 100% grape juice with a meal on postprandial glycemic response and subsequent appetite, food intake and cognitive function.
Read the detailed description
Investigators earlier studies and published literature suggest that the phenolic content and strong flavor intensity of 100% Concord grape juice hold potential beneficial effects on blood sugar levels. Investigators aim to better understand the consumption of 100% grape juice with a meal modifies appetite and glycemia acutely and over the day using a 24 hour glucose monitor.
- Conditions
- Glycemic Response, Appetitive Behavior
- Being tested
- Concord Grape Juice, Low flavonoid low essence beverage, Low flavonoid beverage
- Medical subject headings
- Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concord Grape JuiceOther
Concord Grape Juice
Low flavonoid low essence beverageOther
Low flavonoid low essence beverage
Low flavonoid beverageOther
Low flavonoid beverage
| Study group | Role | What they receive |
|---|---|---|
| Concord Grape Juice | Active comparator | Concord Grape Juice Receives: Other: Concord Grape Juice |
| Low flavonoid low essence beverage | Sham comparator | Low flavonoid low essence beverage Receives: Other: Low flavonoid low essence beverage |
| Low flavonoid beverage | Sham comparator | Low flavonoid beverage Receives: Other: Low flavonoid beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in blood glucose over 24 hours
samples taken every 5 minutes for 24 hours by a continuous glucose monitor
Measured: 24 hours
Secondary outcomes (1)
Appetite
Questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly on same day as grape juice intervention
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start17 May 2019
- Primary completion28 Oct 2019
- Study completion30 Jun 2020
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 Glycemic ResponseStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- Welch's Food Corporation
- Responsible party
- Principal investigator, Richard Mattes, Purdue University
- Investigators
- Richard D Mattes, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409497
- Sponsor's protocol ID
- 055-049
- Status last verified
- Aug 2019
- First submitted
- 18 Jan 2018
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Coelho OGL, Alfenas RCG, Debelo H, Wightman JD, Ferruzzi MG, Mattes RD. Effects of Concord grape juice flavor intensity and phenolic compound content on glycemia, appetite and cognitive function in adults with excess body weight: a randomized double-blind crossover trial. Food Funct. 2021 Nov 15;12(22):11469-11481. doi: 10.1039/d1fo02049h.
PubMed 34698750
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Grape Juice With Breakfast on Glycemia and Cognitive Function in Healthy Adults
- ClinicalTrials.gov ID
- NCT03409497
- Acronym / sponsor ID
- 055-049
- Conditions
- Glycemic Response, Appetitive Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- Welch's Food Corporation
- Study start
- 17 May 2019 (actual)
- Primary completion
- 28 Oct 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 24 Jan 2018 (actual)
- 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.
Assess the impact of 100% grape juice with a meal on postprandial glycemic response and subsequent appetite, food intake and cognitive function.
Detailed description
Investigators earlier studies and published literature suggest that the phenolic content and strong flavor intensity of 100% Concord grape juice hold potential beneficial effects on blood sugar levels. Investigators aim to better understand the consumption of 100% grape juice with a meal modifies appetite and glycemia acutely and over the day using a 24 hour glucose monitor.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Concord Grape Juice | Active comparator | Other: Concord Grape JuiceConcord Grape Juice |
| Low flavonoid low essence beverage | Sham comparator | Other: Low flavonoid low essence beverageLow flavonoid low essence beverage |
| Low flavonoid beverage | Sham comparator | Other: Low flavonoid beverageLow flavonoid beverage |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI between 25.0-34.9 kg/m2
- Willingness to eat all test foods
- Low consumer of tea and coffee, willingness to refrain from both during the 48 hours prior to test days and on the test day
- Fasting blood glucose below 6.1mmol/l via capillary finger-stick blood sample using a SureStep glucometer (Lifescan, Milpitas, CA)
Key exclusion criteria (5 listed)
- Taking medications known to affect glycemia, lipid metabolism or appetite
- Body weight fluctuation of >5kg in the past 3 months
- Taking vitamin or other supplements
- Smokers
- Acute or Chronic disease
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 |
|---|---|---|
| Concord Grape JuiceConcord Grape Juice | Other | Concord Grape Juice |
| Low flavonoid low essence beverageLow flavonoid low essence beverage | Other | Low flavonoid low essence beverage |
| Low flavonoid beverageLow flavonoid beverage | Other | Low flavonoid beverage |
Primary outcome
change in blood glucose over 24 hours
Time frame: 24 hours
samples taken every 5 minutes for 24 hours by a continuous glucose monitor
1 secondary outcome
Appetite
Time frame: 24 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 5 Nov 2020.
- Derived from this study: PubMed 34698750Coelho OGL, Alfenas RCG, Debelo H, Wightman JD, Ferruzzi MG, Mattes RD. Effects of Concord grape juice flavor intensity and phenolic compound content on glycemia, appetite and cognitive function in adults with excess body weight: a randomized double-blind crossover trial. Food Funct. 2021 Nov 15;12(22):11469-11481. doi: 10.1039/d1fo02049h.
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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.
Richard D Mattes, PhD principal investigator
Purdue 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 Concord Grape Juice, Low flavonoid low essence beverage and Low flavonoid beverage in people with Glycemic Response and Appetitive Behavior, run by Purdue 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 4 inclusion and 5 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 5 Nov 2020. 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. 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?
change in blood glucose over 24 hours (time frame: 24 hours). 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 NCT03409497, 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 5 Nov 2020; AzTrials last refreshed its copy on 7 Nov 2026.