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Completed

NCT Number: NCT06748430

Effects on Glycemia and Insulinemia of Different Grape Varieties

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Nutrition Research. University of Navarra

Pamplona, Navarre, 31008, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Grape variety control

Other

Reference grape variety

Grape variety 1

Other

First grape variety to evaluate

Grape variety 2

Other

Second grape variety to evaluate

Primary outcomes

  1. Glycaemic response

    Time frame: 0 minutes

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

  2. Glycaemic response

    Time frame: 15 minutes

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

  3. Glycaemic response

    Time frame: 30 minutes

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

  4. Glycaemic response

    Time frame: 60 minutes

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

  5. Glycaemic response

    Time frame: 90 minutes

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

  6. Glycaemic response

    Time frame: 120 minutes

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

  7. Insulinemic response

    Time frame: 0 minutes

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

  8. Insulinemic response

    Time frame: 15 minutes

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

  9. Insulinemic response

    Time frame: 30 minutes

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

  10. Insulinemic response

    Time frame: 60 minutes

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

  11. Insulinemic response

    Time frame: 90 minutes

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

  12. Insulinemic response

    Time frame: 120 minutes

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

  13. Insulin Resistance Index (HOMA-IR) response

    Time frame: 0 minutes

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

  14. Insulin Resistance Index (HOMA-IR) response

    Time frame: 15 minutes

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

  15. Insulin Resistance Index (HOMA-IR) response

    Time frame: 30 minutes

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

  16. Insulin Resistance Index (HOMA-IR) response

    Time frame: 60 minutes

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

  17. Insulin Resistance Index (HOMA-IR) response

    Time frame: 90 minutes

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

  18. Insulin Resistance Index (HOMA-IR) response

    Time frame: 120 minutes

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

  19. Metabolome composition

    Time frame: 120 minutes

    Metabolomic analysis after grapes consumption

Secondary outcomes

  1. Total cholesterol

    Time frame: 0 minutes

    Serum total cholesterol in fasting state

  2. LDL - cholesterol

    Time frame: 0 minutes

    Serum LDL-cholesterol in fasting state

  3. HDL-cholesterol

    Time frame: 0 minutes

    Serum HDL-cholesterol in fasting state

  4. Triglycerides

    Time frame: 0 minutes

    Serum triglycerides in the fasting state

  5. ALT

    Time frame: 0 minutes

    Serum ALT levels in fasting state

  6. AST

    Time frame: 0 minutes

    Serum AST levels in fasting state

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Registry information

Official study title

Assessment of the Effect of Different Varieties of Grapes on Postprandial Glycemia and Insulinemia

Acronym: SUGARGAP

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 27, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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