ClinicalTrials.gg
CompletedNCT03409484Updated Nov 5, 2020

Effects of Concord Grape Juice Alone on Glycemia, Appetite and Cognitive Function in Healthy Adults

An interventional study of Concord Grape Juice and Low flavoniod low essence beverage in Glycemic Response and Appetitive Behavior, sponsored by Purdue University. Completed at 1 site in United States. Open to participants aged 25 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-05.

Sponsored by Purdue University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
25 Years to 60 Years
Sex
All
01

Study summary

Assess the impact of 100% grape juice on postprandial glycemic response and subsequent appetite, food intake and cognitive function.

Read the detailed description

Investigators earlier clinical work and published literature suggest that the phenolic content and strong flavor intensity of 100% Concord grape juice hold potential beneficial effects on appetite and glycemia. Investigators aim to better understand the use of 100% grape juice modifies appetite and glycemia acutely and over the day using a 24 hour glucose monitor.

02

Conditions studied

  • Glycemic Response
  • Appetitive Behavior

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03

In context

Appetitive Behavior

96 studies on the registry are indexed under Appetitive Behavior; 6 are open to participants now.

This study's enrollment of 40 is above the median of 26 across 87 interventional studies indexed under Appetitive Behavior.

Browse Appetitive Behavior studies →

Lead sponsor

Purdue University is the lead sponsor of 175 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Concord Grape Juice

    100% Concord Grape Juice

    Other: Concord Grape Juice

  • Sham comparator
    Low flavonoid low essence beverage

    Low flavonoid low essence beverage

    Other: Low flavoniod low essence beverage

  • Sham comparator
    Low flavonoid beverage

    Low flavonoid beverage

    Other: Low flavonoid beverage

Interventions

  • OtherConcord Grape Juice

    Concord Grape Juice

  • OtherLow flavoniod low essence beverage

    Low flavoniod low essence beverage

  • OtherLow flavonoid beverage

    Low flavonoid beverage

06

What researchers measure

Primary outcomes

  1. Change in blood glucose over 24 hours

    samples taken every 5 minutes for 24 hours by a continuous glucose monitor

    Time frame: 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

    Time frame: 24 hours

07

Study locations

1 site
  • Purdue University
    West Lafayette, Indiana 47909, United States
08

References and documents

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 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2018 to primary completion in Mar 2019, 5 months.

Of 75 non-industry interventional studies with no phase under Appetitive Behavior, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 16. This study's 5 months is below that.

Counting every sponsor, half of 76 studies reached it within 7 months; a quarter within 3 and three quarters within 16.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 18, 2018
First posted
Jan 24, 2018
StartActual
Oct 10, 2018
Primary completionActual
Mar 28, 2019
CompletionActual
Sep 20, 2019
Last update
Nov 5, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03409484
Lead sponsor
Purdue University
Collaborators
Welch's Food Corporation
Responsible party
Richard Mattes (Principle Investigator, Purdue University) — Principal investigator
First posted
Jan 24, 2018
Start date
Oct 10, 2018
Primary completion
Mar 28, 2019
Completion
Sep 20, 2019
Last update
Nov 5, 2020

Study contacts

Richard D Mattes, PhD
principal investigator · Purdue University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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