Glycaemic Response Measurements, Healthy
Conditions
Keywords
Grape variety, Glycaemic response, metabolome, insulin response
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.
Interventions
OTHERGrape variety control
Reference grape variety
OTHERGrape variety 1
First grape variety to evaluate
OTHERGrape variety 2
Second grape variety to evaluate
Sponsors
Clinica Universidad de Navarra, Universidad de Navarra
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycaemic response | 0 minutes | Assessment of serum glucose evolution after consuming 50 g of carbohydrates in grapes |
| Insulinemic response | 0 minutes | Assessment of serum insulin evolution after consuming 50 g of carbohydrates in grapes |
| Insulin Resistance Index (HOMA-IR) response | 0 minutes | Assessment of insulin resistance evolution after consuming 50 g of carbohydrates in grapes |
| Metabolome composition | 120 minutes | Metabolomic analysis after grapes consumption |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ALT | 0 minutes | Serum ALT levels in fasting state |
| Total cholesterol | 0 minutes | Serum total cholesterol in fasting state |
| AST | 0 minutes | Serum AST levels 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 |
Countries
Spain
Outcome results
None listed