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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Polyphenol-rich drink

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.

Group Type EXPERIMENTAL

Standard meal

Intervention Type OTHER

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.

Placebo drink

The participants consume the control drink.After 3 hours they consume a standard meal to evaluate the metabolic response after a placebo.

Group Type PLACEBO_COMPARATOR

Standard meal

Intervention Type OTHER

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.

Interventions

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Standard meal

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.

Intervention Type OTHER

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes