Effects on Glycemia and Insulinemia of Different Grape Varieties

Not Applicable

Completed

• Conditions: Healthy; Glycaemic Response Measurements

• Registration Number: NCT06748430
• Lead Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

Brief Summary

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

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.

Study Timeline

• Study Start: 2024-06-25
• Status Verified: 2024-11
• Primary Completion: 2024-11-29
• Study Completion: 2024-11-29
• Study First Submitted: 2024-12-19
• Study First Submitted QC: 2024-12-19
• Last Update Submitted: 2024-12-19
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Exclusion Criteria

• Glycaemic levels out of the reference inclusion criteria (below 70 or over 100 mg/dL)
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Glycaemic response	120 minutes	Assessment of serum glucose evolution after consuming 50 g of carbohydrates in grapes
Insulinemic response	120 minutes	Assessment of serum insulin evolution after consuming 50 g of carbohydrates in grapes
Insulin Resistance Index (HOMA-IR) response	120 minutes	Assessment of insulin resistance evolution after consuming 50 g of carbohydrates in grapes
Metabolome composition	120 minutes	Metabolomic analysis after grapes consumption

Secondary Outcome Measures

Name	Time	Method
Total cholesterol	0 minutes	Serum total cholesterol in fasting state
LDL - cholesterol	0 minutes	Serum LDL-cholesterol in fasting state
HDL-cholesterol	0 minutes	Serum HDL-cholesterol in fasting state
Triglycerides	0 minutes	Serum triglycerides in the fasting state
ALT	0 minutes	Serum ALT levels in fasting state
AST	0 minutes	Serum AST levels in fasting state

Trial Locations

Locations (1)

Center for Nutrition Research. University of Navarra; 🇪🇸 Pamplona, Navarra, Spain