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Glycemic Index of Table Grape Varietals

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: NCT03248609
Recruitment Status : Completed
First Posted : August 14, 2017
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
Investigate the postprandial glycemic responses of healthy individuals when consuming commercially available table grape varietals or grape juice, compared to a standard amount of glucose.

Condition or disease Intervention/treatment Phase
Healthy Other: Milano grapes Other: Table grapes Other: Grape juice Other: Glucose beverage Not Applicable

Detailed Description:
The study aims to investigate the postprandial glycemic responses of healthy individuals when consuming commercially available table grape varietals, compared to a standard amount of glucose. The study also aims to evaluate a new grape varietal, compared to other common table grapes, with regard to glycemic index and metabolic response related to inflammation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Investigation of the Glycemic Index of Table Grape Varietals
Actual Study Start Date : July 31, 2017
Actual Primary Completion Date : June 4, 2018
Actual Study Completion Date : June 4, 2018

Arm Intervention/treatment
Experimental: Milano grapes
Unique grape varietal to test glycemic response.
Other: Milano grapes
Milano grapes to test post-prandial glycemic response

Active Comparator: Table grapes
Common grape varietal to test glycemic response and compare to the glycemic response elicited by the Milano grape varietal.
Other: Table grapes
Table grapes to test post-prandial glycemic response

Active Comparator: Grape juice
Used to test the glycemic response without a complex food matrix and compare to the glycemic response elicited by the Milano grape varietal.
Other: Grape juice
Grape juice to test post-prandial glycemic response

Placebo Comparator: Glucose beverage
Used to test the glycemic response with a standardized glucose beverage and compare to the glycemic response elicited by the Milano grape varietal.
Other: Glucose beverage
Standardized glucose beverage to test post-prandial glycemic response




Primary Outcome Measures :
  1. Glycemic Index [ Time Frame: 3 hours ]
    The post-prandial glucose and insulin responses in healthy individuals to glucose containing foods or beverages.



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:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy men and women
  • 21-75 years of age
  • BMI range 20-35

Exclusion Criteria:

  • adults unable to consent, individuals who are not yet adults (children), pregnant women, and prisoners.
  • BMI of >35 or morbid obesity.
  • Diagnosed type 1 or 2 diabetes, fasting blood glucose of >125 mg/dl, or reported use of medications or supplements known to affect glucose metabolism (insulin, sulfonylureas, metformin, glucosidase inhibitors, thiazolidinedione, insulin sensitizers, GLP-1 mimetics).
  • Medications known to affect gastrointestinal motility (prokinetic agents such as reglan).
  • Renal, liver, pancreatic or cardiovascular disease, uncontrolled hypertension of > 160/90, inflammatory bowel disease, disorders of esophageal and gastrointestinal motility, previous gastric resection or restriction procedures, autoimmune or immunologic disorders, anemia, breastfeeding women
  • Food allergy to grapes, or inability to tolerate gluten (celiac disease).
  • Poor venous access.
  • Smoking, illicit drug use, consuming >7 alcoholic drinks per week.
  • Weight gain or loss of > 5 kg within the prior 6 months.
  • Unwillingness to adhere to study protocol.

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): NCT03248609


Locations
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United States, California
University of California Davis (Academic Surge, Ragle Human Nutrition Research Facility)
Davis, California, United States, 95616
Sponsors and Collaborators
University of California, Davis
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03248609    
Other Study ID Numbers: 1086796
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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