Overview

This trial is active, not recruiting.

Condition healthy
Treatment standard meal
Sponsor Federico II University
Start date March 2016
End date July 2016
Trial size 10 participants
Trial identifier NCT02865278, 29/16

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
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.
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.
(Placebo Comparator)
The participants consume the control drink.After 3 hours they consume a standard meal to evaluate the metabolic response after a placebo.
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.

Primary Outcomes

Measure
Phenolic metabolites in urine
time frame: 48 hours

Secondary Outcomes

Measure
Glucose response
time frame: 8 hours
Inflammation
time frame: 8 hours
Oxidative stress (urinary isoprostanes)
time frame: 8 hours
Triglyceride response
time frame: 8 hours

Eligibility Criteria

Male or female participants from 20 years up to 60 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Federico II University.