Effects of Grape Juice With Breakfast on Glycemia and Cognitive Function in Healthy Adults
1 other identifier
interventional
40
1 country
1
Brief Summary
Assess the impact of 100% grape juice with a meal on postprandial glycemic response and subsequent appetite, food intake and cognitive function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2018
CompletedFirst Posted
Study publicly available on registry
January 24, 2018
CompletedStudy Start
First participant enrolled
May 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedNovember 5, 2020
August 1, 2019
5 months
January 18, 2018
November 4, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
change in blood glucose over 24 hours
samples taken every 5 minutes for 24 hours by a continuous glucose monitor
24 hours
Secondary Outcomes (1)
Appetite
24 hours
Study Arms (3)
Concord Grape Juice
ACTIVE COMPARATORConcord Grape Juice
Low flavonoid low essence beverage
SHAM COMPARATORLow flavonoid low essence beverage
Low flavonoid beverage
SHAM COMPARATORLow flavonoid beverage
Interventions
Low flavonoid low essence beverage
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Purdue Universitylead
- Welch's Food Corporationcollaborator
Study Sites (1)
Purdue University
West Lafayette, Indiana, 47909, United States
Related Publications (1)
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.
PMID: 34698750DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard D Mattes, PhD
Purdue University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
January 18, 2018
First Posted
January 24, 2018
Study Start
May 17, 2019
Primary Completion
October 28, 2019
Study Completion
June 30, 2020
Last Updated
November 5, 2020
Record last verified: 2019-08