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

• Sponsor: Purdue University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03409497
• Collaborator: Welch's Food Corporation (Other)
• Enrollment: 40
• Location: 1
• Arms: 3
• Actual Duration (Months): 13.5
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Glycemic Response; Appetitive Behavior	Other: Concord Grape Juice; Other: Low flavonoid low essence beverage; Other: Low flavonoid beverage	N/A

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

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Effects of Grape Juice With Breakfast on Glycemia and Cognitive Function in Healthy Adults
• Actual Study Start Date: May 17, 2019
• Actual Primary Completion Date: Oct 28, 2019
• Actual Study Completion Date: Jun 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Concord Grape Juice Concord Grape Juice	Other: Concord Grape Juice; Concord Grape Juice
Sham Comparator: Low flavonoid low essence beverage Low flavonoid low essence beverage	Other: Low flavonoid low essence beverage; Low flavonoid low essence beverage
Sham Comparator: Low flavonoid beverage Low flavonoid beverage	Other: Low flavonoid beverage; Low flavonoid beverage

Outcome Measures

Primary Outcome Measures

1. change in blood glucose over 24 hours [24 hours]

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

Secondary Outcome Measures

1. Appetite [24 hours]

   Questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly on same day as grape juice intervention

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 60 Years
• Sexes Eligible for Study: 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:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Purdue University	West Lafayette	Indiana	United States	47909

Sponsors and Collaborators

• Purdue University
• Welch's Food Corporation

Investigators

• Principal Investigator: Richard D Mattes, PhD, Purdue University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Richard Mattes, Principle Investigator, Purdue University
• ClinicalTrials.gov Identifier: NCT03409497
• Other Study ID Numbers: 055-049
• First Posted: Jan 24, 2018
• Last Update Posted: Nov 5, 2020
• Last Verified: Aug 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 5, 2020