Effects on Glycemia and Insulinemia of Different Grape Varieties

NCT06748430 | Completed

• 1 other identifier: SUGARGAP
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Glycaemic Response Measurements

Keywords

Grape variety; Glycaemic response; metabolome; insulin response

Outcome Measures

Primary Outcomes (19)

• Glycaemic response

  Assessment of serum glucose evolution after consuming 50 g of carbohydrates in grapes

  0 minutes

• Glycaemic response

  Assessment of serum glucose evolution after consuming 50 g of carbohydrates in grapes

  15 minutes

• Glycaemic response

  Assessment of serum glucose evolution after consuming 50 g of carbohydrates in grapes

  30 minutes

• Glycaemic response

  Assessment of serum glucose evolution after consuming 50 g of carbohydrates in grapes

  60 minutes

• Glycaemic response

  Assessment of serum glucose evolution after consuming 50 g of carbohydrates in grapes

  90 minutes

• Glycaemic response

  Assessment of serum glucose evolution after consuming 50 g of carbohydrates in grapes

  120 minutes

• Insulinemic response

  Assessment of serum insulin evolution after consuming 50 g of carbohydrates in grapes

  0 minutes

• Insulinemic response

  Assessment of serum insulin evolution after consuming 50 g of carbohydrates in grapes

  15 minutes

• Insulinemic response

  Assessment of serum insulin evolution after consuming 50 g of carbohydrates in grapes

  30 minutes

• Insulinemic response

  Assessment of serum insulin evolution after consuming 50 g of carbohydrates in grapes

  60 minutes

• Insulinemic response

  Assessment of serum insulin evolution after consuming 50 g of carbohydrates in grapes

  90 minutes

• Insulinemic response

  Assessment of serum insulin evolution after consuming 50 g of carbohydrates in grapes

  120 minutes

• Insulin Resistance Index (HOMA-IR) response

  Assessment of insulin resistance evolution after consuming 50 g of carbohydrates in grapes

  0 minutes

• Insulin Resistance Index (HOMA-IR) response

  Assessment of insulin resistance evolution after consuming 50 g of carbohydrates in grapes

  15 minutes

• Insulin Resistance Index (HOMA-IR) response

  Assessment of insulin resistance evolution after consuming 50 g of carbohydrates in grapes

  30 minutes

• Insulin Resistance Index (HOMA-IR) response

  Assessment of insulin resistance evolution after consuming 50 g of carbohydrates in grapes

  60 minutes

• Insulin Resistance Index (HOMA-IR) response

  Assessment of insulin resistance evolution after consuming 50 g of carbohydrates in grapes

  90 minutes

• Insulin Resistance Index (HOMA-IR) response

  Assessment of insulin resistance evolution after consuming 50 g of carbohydrates in grapes

  120 minutes

• Metabolome composition

  Metabolomic analysis after grapes consumption

  120 minutes

Secondary Outcomes (6)

• Total cholesterol

  0 minutes

• LDL - cholesterol

  0 minutes

• HDL-cholesterol

  0 minutes

• Triglycerides

  0 minutes

• ALT

  0 minutes

Study Arms (3)

Variety 1 (timpson)

PLACEBO COMPARATOR

Reference variety

Other: Grape variety control

Variety 2 (18INV-1438-10)

ACTIVE COMPARATOR

First comparator

Other: Grape variety 1

Variety 3 (18-1465-110)

ACTIVE COMPARATOR

Second comparator

Other: Grape variety 2

Interventions

Grape variety control OTHER

Reference grape variety

Variety 1 (timpson)

Grape variety 1 OTHER

First grape variety to evaluate

Variety 2 (18INV-1438-10)

Grape variety 2 OTHER

Second grape variety to evaluate

Variety 3 (18-1465-110)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

Center for Nutrition Research. University of Navarra

Pamplona, Navarre, 31008, Spain

Location

Study Officials

• Santiago Navas-Carretero, PhD

  University of Navarra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher at the Center for Nutrition Research, Universidad de Navarra

Model Details: 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.

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 27, 2024
• Study Start: June 25, 2024
• Primary Completion: November 29, 2024
• Study Completion: November 29, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-11

Locations

ES (1)