Glycemic Index of Table Grape Varietals

NCT ID: NCT03248609

Last Updated: 2019-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-31

Study Completion Date

2018-06-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Milano grapes

Unique grape varietal to test glycemic response.

Group Type EXPERIMENTAL

Milano grapes

Intervention Type OTHER

Milano grapes to test post-prandial glycemic response

Table grapes

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

Group Type ACTIVE_COMPARATOR

Table grapes

Intervention Type OTHER

Table grapes to test post-prandial glycemic response

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.

Group Type ACTIVE_COMPARATOR

Grape juice

Intervention Type OTHER

Grape juice to test post-prandial glycemic response

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.

Group Type PLACEBO_COMPARATOR

Glucose beverage

Intervention Type OTHER

Standardized glucose beverage to test post-prandial glycemic response

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Milano grapes

Milano grapes to test post-prandial glycemic response

Intervention Type OTHER

Table grapes

Table grapes to test post-prandial glycemic response

Intervention Type OTHER

Grape juice

Grape juice to test post-prandial glycemic response

Intervention Type OTHER

Glucose beverage

Standardized glucose beverage to test post-prandial glycemic response

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Davis, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1086796

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Glycemic Index of Foods
NCT01205698 COMPLETED NA
Corn Glycemic Index
NCT06847815 ACTIVE_NOT_RECRUITING NA