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

Healthy Clinical Trial

— BIOP  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02865278
• Other study ID #: 29/16
• Status: Active, not recruiting
• Phase: N/A
• First received: July 15, 2016
• Last updated: August 9, 2016
• Start date: March 2016

Study information

• Verified date: July 2016
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phenolic metabolites in urine	GCxGC-MS	48 hours	No
Secondary	Glucose response	Enzymatic colorimetric methods	8 hours	No
Secondary	Inflammation	Multiplex Detection Immunoassays	8 hours	No
Secondary	Oxidative stress (urinary isoprostanes)	EIA	8 hours	No
Secondary	Triglyceride response	Enzymatic colorimetric methods	8 hours	No