Glycemic Index of Table Grape Varietals

NCT03248609 | Completed

• 1 other identifier: 1086796
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Glycemic Index

  The post-prandial glucose and insulin responses in healthy individuals to glucose containing foods or beverages.

  3 hours

Study Arms (4)

Milano grapes

EXPERIMENTAL

Unique grape varietal to test glycemic response.

Other: Milano grapes

Table grapes

ACTIVE COMPARATOR

Common grape varietal to test glycemic response and compare to the glycemic response elicited by the Milano grape varietal.

Other: Table grapes

Grape juice

ACTIVE COMPARATOR

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

Glucose beverage

PLACEBO COMPARATOR

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

Interventions

Milano grapes OTHER

Milano grapes to test post-prandial glycemic response

Milano grapes

Table grapes OTHER

Table grapes to test post-prandial glycemic response

Table grapes

Grape juice OTHER

Grape juice to test post-prandial glycemic response

Grape juice

Glucose beverage OTHER

Standardized glucose beverage to test post-prandial glycemic response

Glucose beverage

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California Davis (Academic Surge, Ragle Human Nutrition Research Facility)

Davis, California, 95616, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 14, 2017
• Study Start: July 31, 2017
• Primary Completion: June 4, 2018
• Study Completion: June 4, 2018
• Last Updated: May 2, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)