Glycemic Index of Table Grape Varietals

Investigation of the Glycemic Index of Table Grape Varietals

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Milano grapes; Other: Table grapes; Other: Grape juice; Other: Glucose beverage

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Davis, California, United States, 95616
      • University of California Davis (Academic Surge, Ragle Human Nutrition Research Facility)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic Index	The post-prandial glucose and insulin responses in healthy individuals to glucose containing foods or beverages.	3 hours

Collaborators and Investigators

• Sponsor: University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2017
• Primary Completion (Actual): June 4, 2018
• Study Completion (Actual): June 4, 2018

Study Registration Dates

• First Submitted: August 9, 2017
• First Submitted That Met QC Criteria: August 9, 2017
• First Posted (Actual): August 14, 2017

Study Record Updates

• Last Update Posted (Actual): May 2, 2019
• Last Update Submitted That Met QC Criteria: April 30, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 1086796

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No