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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03409497
Recruitment Status : Recruiting
First Posted : January 24, 2018
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
Welch's Food Corporation
Information provided by (Responsible Party):
Richard Mattes, Purdue University

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

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




Primary Outcome Measures :
  1. change in blood glucose over 24 hours [ Time Frame: 24 hours ]
    samples taken every 5 minutes for 24 hours by a continuous glucose monitor


Secondary Outcome Measures :
  1. Appetite [ Time Frame: 24 hours ]
    Questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly on same day as grape juice intervention



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03409497


Contacts
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Contact: Richard D Mattes, PhD 765-494-0662 mattes@purdue.edu
Contact: Judy C George 765-494-6192 georgej@purdue.edu

Locations
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United States, Indiana
Purdue University Recruiting
West Lafayette, Indiana, United States, 47909
Contact: Richard D Mattes, PhD    765-494-0662    mattes@purdue.edu   
Contact: Judy C George    765-494-6192    georgej@purdue.edu   
Sponsors and Collaborators
Purdue University
Welch's Food Corporation
Investigators
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Principal Investigator: Richard D Mattes, PhD Purdue University

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Responsible Party: Richard Mattes, Principle Investigator, Purdue University
ClinicalTrials.gov Identifier: NCT03409497    
Other Study ID Numbers: 055-049
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019

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