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

F

Federico II University

Status

Unknown

Conditions

Healthy

Treatments

Other: Standard meal

Study type

Interventional

Funder types

Other

Identifiers

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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