Clinical trial NCT06748430: Effects on Glycemia and Insulinemia of Different Grape Varieties
Official title: Assessment of the Effect of Different Varieties of Grapes on Postprandial Glycemia and Insulinemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Glycaemic Response Measurements
Keywords: Grape variety
Glycaemic response
metabolome
insulin response
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Glycaemic response
timeFrame: 0 minutes
measure: Glycaemic response
timeFrame: 15 minutes
measure: Glycaemic response
timeFrame: 30 minutes
measure: Glycaemic response
timeFrame: 60 minutes
measure: Glycaemic response
timeFrame: 90 minutes
measure: Glycaemic response
timeFrame: 120 minutes
measure: Insulinemic response
timeFrame: 0 minutes
measure: Insulinemic response
timeFrame: 15 minutes
measure: Insulinemic response
timeFrame: 30 minutes
measure: Insulinemic response
timeFrame: 60 minutes
measure: Insulinemic response
timeFrame: 90 minutes
measure: Insulinemic response
timeFrame: 120 minutes
measure: Insulin Resistance Index (HOMA-IR) response
timeFrame: 0 minutes
measure: Insulin Resistance Index (HOMA-IR) response
timeFrame: 15 minutes
measure: Insulin Resistance Index (HOMA-IR) response
timeFrame: 30 minutes
measure: Insulin Resistance Index (HOMA-IR) response
timeFrame: 60 minutes
measure: Insulin Resistance Index (HOMA-IR) response
timeFrame: 90 minutes
measure: Insulin Resistance Index (HOMA-IR) response
timeFrame: 120 minutes
measure: Metabolome composition
timeFrame: 120 minutes
Secondary outcomes:
measure: Total cholesterol
timeFrame: 0 minutes
measure: LDL - cholesterol
timeFrame: 0 minutes
measure: HDL-cholesterol
timeFrame: 0 minutes
measure: Triglycerides
timeFrame: 0 minutes
measure: ALT
timeFrame: 0 minutes
measure: AST
timeFrame: 0 minutes
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Center for Nutrition Research. University of Navarra
state: Navarra
Study officials:
affiliation: University of Navarra
name: Santiago Navas-Carretero, PhD
role: PRINCIPAL_INVESTIGATOR
References: