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CompletedNCT03409497Updated Nov 5, 2020

Effects of Grape Juice With Breakfast on Glycemia and Cognitive Function in Healthy Adults

An interventional study of Concord Grape Juice and Low flavonoid 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 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.

02

Conditions studied

  • Glycemic Response
  • Appetitive Behavior
03

Who can participate

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

Inclusion criteria

  • 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)

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
04

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

    Concord Grape Juice

    Other: Concord Grape Juice

  • Sham comparator
    Low flavonoid low essence beverage

    Low flavonoid low essence beverage

    Other: Low flavonoid low essence beverage

  • Sham comparator
    Low flavonoid beverage

    Low flavonoid beverage

    Other: Low flavonoid beverage

Interventions

  • OtherConcord Grape Juice

    Concord Grape Juice

  • OtherLow flavonoid low essence beverage

    Low flavonoid low essence beverage

  • OtherLow flavonoid beverage

    Low flavonoid beverage

05

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

06

Study locations

1 site
  • Purdue University
    West Lafayette, Indiana 47909, United States
07

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 ↗
08

Registry details

Key details

Study ID
NCT03409497
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
May 17, 2019
Primary completion
Oct 28, 2019
Completion
Jun 30, 2020
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 ↗

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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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