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Effects of Concord Grape Juice Alone on Glycemia, Appetite 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03409484
Recruitment Status : Active, not recruiting
First Posted : January 24, 2018
Last Update Posted : August 27, 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 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 flavoniod low essence beverage Other: Low flavonoid beverage Not Applicable

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.

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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 Concord Grape Juice Alone on Glycemia, Appetite and Cognitive Function in Healthy Adults
Actual Study Start Date : October 10, 2018
Actual Primary Completion Date : March 28, 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
Active Comparator: Concord Grape Juice
100% Concord Grape Juice
Other: Concord Grape Juice
Concord Grape Juice

Sham Comparator: Low flavonoid low essence beverage
Low flavonoid low essence beverage
Other: Low flavoniod low essence beverage
Low flavoniod 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

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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): NCT03409484


Locations
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United States, Indiana
Purdue University
West Lafayette, Indiana, United States, 47909
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: NCT03409484     History of Changes
Other Study ID Numbers: 055-048
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: August 27, 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