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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03248609
Other study ID # 1086796
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 31, 2017
Est. completion date June 4, 2018

Study information

Verified date April 2019
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date June 4, 2018
Est. primary completion date June 4, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Milano grapes
Milano grapes to test post-prandial glycemic response
Table grapes
Table grapes to test post-prandial glycemic response
Grape juice
Grape juice to test post-prandial glycemic response
Glucose beverage
Standardized glucose beverage to test post-prandial glycemic response

Locations

Country Name City State
United States University of California Davis (Academic Surge, Ragle Human Nutrition Research Facility) Davis California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Glycemic Index The post-prandial glucose and insulin responses in healthy individuals to glucose containing foods or beverages. 3 hours
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