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

Not Applicable

• Conditions: Healthy

• Registration Number: NCT02865278
• Lead Sponsor: Federico II University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Status Verified: 2016-07
• Primary Completion: 2016-07
• Study First Submitted: 2016-07-15
• Study First Submitted QC: 2016-08-09
• Last Update Submitted: 2016-08-09
• Study First Posted: 2016-08-12
• Last Update Posted: 2016-08-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Phenolic metabolites in urine	48 hours	GCxGC-MS

Secondary Outcome Measures

Name	Time	Method
Triglyceride response	8 hours	Enzymatic colorimetric methods
Glucose response	8 hours	Enzymatic colorimetric methods
Inflammation	8 hours	Multiplex Detection Immunoassays
Oxidative stress (urinary isoprostanes)	8 hours	EIA