Glycemic Index of Table Grape Varietals

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Investigation of the Glycemic Index of Table Grape Varietals

Conditions
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Healthy

Intervention / Treatment
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* Other: Milano grapes
* Other: Table grapes
* Other: Grape juice
* Other: Glucose beverage


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Milano grapes<br>Unique grape varietal to test glycemic response. | Other: Milano grapes<br>* Milano grapes to test post-prandial glycemic response<br>|
| Active Comparator: Table grapes<br>Common grape varietal to test glycemic response and compare to the glycemic response elicited by the Milano grape varietal. | Other: Table grapes<br>* Table grapes to test post-prandial glycemic response<br>|
| Active Comparator: Grape juice<br>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<br>* Grape juice to test post-prandial glycemic response<br>|
| Placebo Comparator: Glucose beverage<br>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<br>* Standardized glucose beverage to test post-prandial glycemic response<br>|

What is the study measuring?
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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 |