MedDataX Logo

Effects on Glycemia and Insulinemia of Different Grape Varieties

NCT ID: NCT06748430

Last Updated: 2024-12-27

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-25

Study Completion Date

2024-11-29

Brief Summary

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

The goal of this intervention study is to examine the glucose increase in blood, during 2 hours after consuming different varieties of grapes, in men and women with normal or excess body weight. The main question it aims to answer is:

can a variety of red grape reduce the glucose curve compared to a reference variety?

Participants will have to attend the Center for nutrition research facilities in three occasions, fasted for at least 8 hours. Once there, they will be measured and monitored. A canula will be inserted and once they finish eating 300g of grapes, blood extractions will be performed at minutes 15, 30, 60, 90 and 120.

Detailed Description

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

The main purpose of this study is to evaluate how the glucose and insulin curves develop after consuming different grapes varieties. Still, we also want to evaluate how the serum metabolome changes with the three varieties after 120 minutes. Therefore, a metabolomic study will be done in samples of volunteers at this time point.

The intervention is longitudinal and in three arms (one per variety). Due to the harvest of the different varieties, it cannot be crossover, but each subject will consume the three varieties.

At each visit, the subjects will undergo the same schedule:

* Arrival in a fasting state of at least 8 hours.
* Insertion of cannula and extraction of fasting samples
* Consumption of approximately 300 g of grapes (50 g of Carbohydrates).
* Extraction of blood samples at 15, 30, 60, 90 and 120 minutes.

Conditions

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

Healthy Glycaemic Response Measurements

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Grape variety Glycaemic response metabolome insulin response

Study Design

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

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

The group of subjects will go through the three visits of the study in the same order. All subjects will consume the same variety at the same time.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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

Variety 1 (timpson)

Reference variety

Group Type PLACEBO_COMPARATOR

Grape variety control

Intervention Type OTHER

Reference grape variety

Variety 2 (18INV-1438-10)

First comparator

Group Type ACTIVE_COMPARATOR

Grape variety 1

Intervention Type OTHER

First grape variety to evaluate

Variety 3 (18-1465-110)

Second comparator

Group Type ACTIVE_COMPARATOR

Grape variety 2

Intervention Type OTHER

Second grape variety to evaluate

Interventions

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

Grape variety control

Reference grape variety

Intervention Type OTHER

Grape variety 1

First grape variety to evaluate

Intervention Type OTHER

Grape variety 2

Second grape variety to evaluate

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* Baseline glycaemia between 70 and 100 mg/dL
* BMI between 18.5 kg/m2 and 29.9 kg/m2.
* Absence of disease or alterations related to gastrointestinal status.
* Signed written informed consent.

* Subjects presenting BMI out of the limits set.
* Subjects with unstable body weight the three months prior the start of the study (+/- 3 Kg)
* Subjects not able to attend the preestablished visits
* Women pregnant or lactating
* Subjects undergoing pharmacological treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

Clinica Universidad de Navarra, Universidad de Navarra

OTHER

Sponsor Role lead

Responsible Party

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

Santiago Navas

Researcher at the Center for Nutrition Research, Universidad de Navarra

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Santiago Navas-Carretero, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Navarra

Locations

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

Center for Nutrition Research. University of Navarra

Pamplona, Navarre, Spain

Site Status

Countries

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

Spain

Other Identifiers

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

SUGARGAP

Identifier Type: -

Identifier Source: org_study_id