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

November 4, 2020 updated by: Richard Mattes, Purdue University
Assess the impact of 100% grape juice with a meal on postprandial glycemic response and subsequent appetite, food intake and cognitive function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • West Lafayette, Indiana, United States, 47909
        • Purdue University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Concord Grape Juice
Other: Concord Grape Juice
Concord Grape Juice
SHAM_COMPARATOR: Low flavonoid low essence beverage
Other: Low flavonoid low essence beverage
Low flavonoid low essence beverage
SHAM_COMPARATOR: Low flavonoid beverage
Other: Low flavonoid beverage
Low flavonoid beverage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in blood glucose over 24 hours
Time Frame: 24 hours
samples taken every 5 minutes for 24 hours by a continuous glucose monitor
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appetite
Time Frame: 24 hours
Questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly on same day as grape juice intervention
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Purdue University

Collaborators

Welch's Food Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 17, 2019

Primary Completion (ACTUAL)

October 28, 2019

Study Completion (ACTUAL)

June 30, 2020

Study Registration Dates

First Submitted

January 18, 2018

First Submitted That Met QC Criteria

January 23, 2018

First Posted (ACTUAL)

January 24, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 5, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 055-049

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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