Bioavailability of the Polyphenols Contained in a Red Grape Extract-based Drink and Their Metabolic Effects

Study Overview
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Brief Summary
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Randomized placebo-controlled crossover study during which participants undergo two different experimental days. The participants consume a red grape based- drink (polyphenols: 300 mg/100 ml and sugar: 9.8g/100 ml) or a placebo (no polyphenols and sugar: 9.8g/100 ml). After 3 hours they consume a test meal (905 kcal, 15% protein, 46% fat, 39% CHO). Blood samples are taken at fasting, over 3 hours after drink consumption and over 5 hours after the test meal to evaluate metabolic response. Fasting and 48h-urine are collected to evaluate bioavailability.

Official Title
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Evaluation of the Bioavailability of Polyphenols From a Red Grape Extract-based Drink and the Acute Effects of Its Consumption on Glucose and Lipid Response During the Subsequent Meal

Conditions
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Healthy

Intervention / Treatment
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* Other: Standard meal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI >25 and <35 kg/m2 Total cholesterol <250 mg/dl Triglyceride < 200 mg/dl. Fasting glucose <100 mg/dl Exclusion Criteria: Cardiovascular events (IMA or stroke) in the 6 months prior to the study Kidney or liver failure Anemia (Hb <12 g/dl) Any chronic disease Intense physical activity Dietary supplements

Ages Eligible for Study
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Minimum Age: 20 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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polyphenol-rich drink<br>The participants consume the polyphenol-rich drink. After 3 hours they consume a standard meal to evaluate whether the metabolic response may be influenced by polyphenols. | Other: Standard meal<br>* The participants consume the drink, experimental or placebo drink. After 3 hours they consume a standard meal (905 kcal, 15% protein, 46% fat, 39% CHO). Blood samples are taken at fasting, over 3 hours after drink consumption and over 5 hours after the test meal to evaluate metabolic response. Fasting and 48h-urine are collected to evaluate bioavailability of polyphenol.<br>|
| Placebo Comparator: Placebo drink<br>The participants consume the control drink.After 3 hours they consume a standard meal to evaluate the metabolic response after a placebo. | Other: Standard meal<br>* The participants consume the drink, experimental or placebo drink. After 3 hours they consume a standard meal (905 kcal, 15% protein, 46% fat, 39% CHO). Blood samples are taken at fasting, over 3 hours after drink consumption and over 5 hours after the test meal to evaluate metabolic response. Fasting and 48h-urine are collected to evaluate bioavailability of polyphenol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phenolic metabolites in urine | GCxGC-MS | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose response | Enzymatic colorimetric methods | 8 hours | 
| Inflammation | Multiplex Detection Immunoassays | 8 hours | 
| Oxidative stress (urinary isoprostanes) | EIA | 8 hours | 
| Triglyceride response | Enzymatic colorimetric methods | 8 hours |