HealthySUGARGAPNCT06748430
Effects on Glycemia and Insulinemia of Different Grape Varieties
A study testing Grape variety 1 and Grape variety 2 in people with Healthy and Glycaemic Response Measurements, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Glycaemic Response Measurements
- What is being tested?
- Grape variety 1 and Grape variety 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 25 Jun 2024to 29 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Center for Nutrition Research. University of Navarra
Pamplona, Navarre, 31008
About this study
Official title: Assessment of the Effect of Different Varieties of Grapes on Postprandial Glycemia and Insulinemia
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.
Read the 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.
- Conditions
- Healthy, Glycaemic Response Measurements
- Being tested
- Grape variety control, Grape variety 1, Grape variety 2
- Keywords
- Grape variety, Glycaemic response, metabolome, insulin response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grape variety controlOther
Reference grape variety
Grape variety 1Other
First grape variety to evaluate
Grape variety 2Other
Second grape variety to evaluate
| Study group | Role | What they receive |
|---|---|---|
| Variety 1 (timpson) | Placebo comparator | Reference variety Receives: Other: Grape variety control |
| Variety 2 (18INV-1438-10) | Active comparator | First comparator Receives: Other: Grape variety 1 |
| Variety 3 (18-1465-110) | Active comparator | Second comparator Receives: Other: Grape variety 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycaemic response
Assessment of serum glucose evolution after consuming 50 g of carbohydrates in grapes
Measured: 0 minutes
Glycaemic response
Assessment of serum glucose evolution after consuming 50 g of carbohydrates in grapes
Measured: 15 minutes
Glycaemic response
Assessment of serum glucose evolution after consuming 50 g of carbohydrates in grapes
Measured: 30 minutes
Glycaemic response
Assessment of serum glucose evolution after consuming 50 g of carbohydrates in grapes
Measured: 60 minutes
Glycaemic response
Assessment of serum glucose evolution after consuming 50 g of carbohydrates in grapes
Measured: 90 minutes
Glycaemic response
Assessment of serum glucose evolution after consuming 50 g of carbohydrates in grapes
Measured: 120 minutes
Insulinemic response
Assessment of serum insulin evolution after consuming 50 g of carbohydrates in grapes
Measured: 0 minutes
Insulinemic response
Assessment of serum insulin evolution after consuming 50 g of carbohydrates in grapes
Measured: 15 minutes
Insulinemic response
Assessment of serum insulin evolution after consuming 50 g of carbohydrates in grapes
Measured: 30 minutes
Insulinemic response
Assessment of serum insulin evolution after consuming 50 g of carbohydrates in grapes
Measured: 60 minutes
Insulinemic response
Assessment of serum insulin evolution after consuming 50 g of carbohydrates in grapes
Measured: 90 minutes
Insulinemic response
Assessment of serum insulin evolution after consuming 50 g of carbohydrates in grapes
Measured: 120 minutes
Insulin Resistance Index (HOMA-IR) response
Assessment of insulin resistance evolution after consuming 50 g of carbohydrates in grapes
Measured: 0 minutes
Insulin Resistance Index (HOMA-IR) response
Assessment of insulin resistance evolution after consuming 50 g of carbohydrates in grapes
Measured: 15 minutes
Insulin Resistance Index (HOMA-IR) response
Assessment of insulin resistance evolution after consuming 50 g of carbohydrates in grapes
Measured: 30 minutes
Insulin Resistance Index (HOMA-IR) response
Assessment of insulin resistance evolution after consuming 50 g of carbohydrates in grapes
Measured: 60 minutes
Insulin Resistance Index (HOMA-IR) response
Assessment of insulin resistance evolution after consuming 50 g of carbohydrates in grapes
Measured: 90 minutes
Insulin Resistance Index (HOMA-IR) response
Assessment of insulin resistance evolution after consuming 50 g of carbohydrates in grapes
Measured: 120 minutes
Metabolome composition
Metabolomic analysis after grapes consumption
Measured: 120 minutes
Secondary outcomes (6)
Total cholesterol
Serum total cholesterol in fasting state
Measured: 0 minutes
LDL - cholesterol
Serum LDL-cholesterol in fasting state
Measured: 0 minutes
HDL-cholesterol
Serum HDL-cholesterol in fasting state
Measured: 0 minutes
Triglycerides
Serum triglycerides in the fasting state
Measured: 0 minutes
ALT
Serum ALT levels in fasting state
Measured: 0 minutes
AST
Serum AST levels in fasting state
Measured: 0 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start25 Jun 2024
- Primary completion29 Nov 2024
- Study completion29 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Santiago Navas, Clinica Universidad de Navarra, Universidad de Navarra
- Investigators
- Santiago Navas-Carretero, PhD, Principal investigator, University of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748430
- Sponsor's protocol ID
- SUGARGAP
- Acronym
- SUGARGAP
- Status last verified
- Nov 2024
- First submitted
- 19 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of Different Varieties of Grapes on Postprandial Glycemia and Insulinemia
- ClinicalTrials.gov ID
- NCT06748430
- Acronym / sponsor ID
- SUGARGAP / SUGARGAP
- Conditions
- Healthy, Glycaemic Response Measurements
- Keywords
- Grape variety, Glycaemic response, metabolome, insulin response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 29 Nov 2024 (actual)
- Study completion
- 29 Nov 2024 (actual)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Variety 1 (timpson) | Placebo comparator | Other: Grape variety controlReference variety |
| Variety 2 (18INV-1438-10) | Active comparator | Other: Grape variety 1First comparator |
| Variety 3 (18-1465-110) | Active comparator | Other: Grape variety 2Second comparator |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grape variety controlReference grape variety | Other | Variety 1 (timpson) |
| Grape variety 1First grape variety to evaluate | Other | Variety 2 (18INV-1438-10) |
| Grape variety 2Second grape variety to evaluate | Other | Variety 3 (18-1465-110) |
Primary outcome
Glycaemic response
Time frame: 0 minutes
Assessment of serum glucose evolution after consuming 50 g of carbohydrates in grapes
Glycaemic response
Time frame: 15 minutes
Assessment of serum glucose evolution after consuming 50 g of carbohydrates in grapes
Glycaemic response
Time frame: 30 minutes
Assessment of serum glucose evolution after consuming 50 g of carbohydrates in grapes
Glycaemic response
Time frame: 60 minutes
Assessment of serum glucose evolution after consuming 50 g of carbohydrates in grapes
Glycaemic response
Time frame: 90 minutes
Assessment of serum glucose evolution after consuming 50 g of carbohydrates in grapes
Glycaemic response
Time frame: 120 minutes
Assessment of serum glucose evolution after consuming 50 g of carbohydrates in grapes
Insulinemic response
Time frame: 0 minutes
Assessment of serum insulin evolution after consuming 50 g of carbohydrates in grapes
Insulinemic response
Time frame: 15 minutes
Assessment of serum insulin evolution after consuming 50 g of carbohydrates in grapes
Insulinemic response
Time frame: 30 minutes
Assessment of serum insulin evolution after consuming 50 g of carbohydrates in grapes
Insulinemic response
Time frame: 60 minutes
Assessment of serum insulin evolution after consuming 50 g of carbohydrates in grapes
Insulinemic response
Time frame: 90 minutes
Assessment of serum insulin evolution after consuming 50 g of carbohydrates in grapes
Insulinemic response
Time frame: 120 minutes
Assessment of serum insulin evolution after consuming 50 g of carbohydrates in grapes
Insulin Resistance Index (HOMA-IR) response
Time frame: 0 minutes
Assessment of insulin resistance evolution after consuming 50 g of carbohydrates in grapes
Insulin Resistance Index (HOMA-IR) response
Time frame: 15 minutes
Assessment of insulin resistance evolution after consuming 50 g of carbohydrates in grapes
Insulin Resistance Index (HOMA-IR) response
Time frame: 30 minutes
Assessment of insulin resistance evolution after consuming 50 g of carbohydrates in grapes
Insulin Resistance Index (HOMA-IR) response
Time frame: 60 minutes
Assessment of insulin resistance evolution after consuming 50 g of carbohydrates in grapes
Insulin Resistance Index (HOMA-IR) response
Time frame: 90 minutes
Assessment of insulin resistance evolution after consuming 50 g of carbohydrates in grapes
Insulin Resistance Index (HOMA-IR) response
Time frame: 120 minutes
Assessment of insulin resistance evolution after consuming 50 g of carbohydrates in grapes
Metabolome composition
Time frame: 120 minutes
Metabolomic analysis after grapes consumption
6 secondary outcomes
Total cholesterol
Time frame: 0 minutes
LDL - cholesterol
Time frame: 0 minutes
HDL-cholesterol
Time frame: 0 minutes
Triglycerides
Time frame: 0 minutes
ALT
Time frame: 0 minutes
AST
Time frame: 0 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Santiago Navas-Carretero, PhD principal investigator
University of Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grape variety 1 and Grape variety 2 in people with Healthy and Glycaemic Response Measurements, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycaemic response (time frame: 0 minutes). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.