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

Federico II University

Status: Unknown

Conditions: Healthy

Treatments: Other: Standard meal

Study type: Interventional

Funder types: Other

Identifiers

NCT02865278

29/16

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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10 participants in 2 patient groups, including a placebo group

Polyphenol-rich drink

Experimental group

Description:

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.

Treatment:

Other: Standard meal

Placebo drink

Placebo Comparator group

Description:

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

Treatment:

Other: Standard meal