Grape and Pomegranate Polyphenols in Postprandial Glucose and Related Parameters

Study Overview
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Brief Summary
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The aim of this is study is to evaluate the acute effect of grape and pomegranate polyphenols in the modulation of markers of metabolic syndrome. Most of the previous works about polyphenols have only considered a fraction of polyphenols, i.e., extractable polyphenols. As a consequence, an important amount of dietary polyphenols, the so-called non-extractable polyphenols are ignored. In contrast, the effect of both extractable and non-extractable polyphenols will be considered in this study. Furthermore, the effect of both polyphenols as present in the food matrix and metabolites derived from microbial fermentation will be evaluated.

Official Title
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Acute Effects of Grape and Pomegranate Polyphenols as Modulators of Metabolic Syndrome in Humans

Conditions
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Subjects With Abdominal Obesity

Intervention / Treatment
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* Dietary Supplement: Mixture of grape pomace and pomegranate pomace
* Dietary Supplement: Mixture of grape pomace and pomegranate pomace
* Dietary Supplement: Mixture of grape pomace and pomegranate pomace


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Abdominal perimeter ≥102 cm. for male participants and ≥88 cm for female participants. Subjects presenting some or several of these characteristics will be prioritized: Fasting glucose values between 110-128 mg/dL. Triglycerides = 150-195 mg/dL. HDL-cholesterol: < 50 mg/dL men, < 40 mg/dL women. Blood pressure: systolic > 130 mm Hg; diastolic > 85 mm Hg. Exclusion Criteria: Subjects taking drugs for hyperglycaemia, hypertension or hypercholesterolaemia. Volunteers participating in other studies or weight loss plans. Pregnant or breastfeeding women.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects with abdominal obesity<br>Intervention with grape pomace and pomegranate pomace | Dietary Supplement: Mixture of grape pomace and pomegranate pomace<br>* Oral Glucose Tolerance Test<br>Dietary Supplement: Mixture of grape pomace and pomegranate pomace<br>* Oral Glucose Tolerance Test right after taking the mixture of grape and pomegranate polyphenols<br>Dietary Supplement: Mixture of grape pomace and pomegranate pomace<br>* Oral Glucose Tolerance Test ten hours after taking the mixture of grape and pomegranate polyphenols<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial glucose | Changes in blood glucose response in treatments B and C will be compared with the baseline results obtained in treatment A. This will be evaluated by area under the curve (AUC) 0-120 min after an Oral Glucose Tolerance Test (OGTT) | 0-120 min. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial insulin | Changes in blood insulin response in treatments B and C will be compared with the baseline results obtained in treatment A. This will be evaluated by area under the curve (AUC) 0-120 min after an Oral Glucose Tolerance Test (OGTT) | 0-120 min. | 
| Postprandial uric acid | Changes in blood uric acid response in treatments B and C will be compared with the baseline results obtained in treatment A. This will be evaluated by area under the curve (AUC) 0-120 min after an Oral Glucose Tolerance Test (OGTT) | 0-120 min. | 
| Polyphenol metabolites | Urinary polyphenol metabolites will be determined in samples collected in the period 0-180 min. of each intervention. | 0-180 min. | 
| Urinary uric acid | Urinary uric acid will be determined in samples collected in the period 0-180 min. of each intervention. | 0-180 min. | 
| Satiety | A satiety test, including 10 items, will be provided at different time points during the period 0-120 min. of each intervention. | 120 min. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polyphenols, Grape, Pomegranate, Metabolic syndrome, Abdominal obesity, Postprandial glucose, Insulin resistance