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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02865278

Acronym

BIOP

Enrollment

Registered

2016-08-12

Start date

2016-03-31

Completion date

Unknown

Last updated

2016-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

OTHERStandard 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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Phenolic metabolites in urine	48 hours	GCxGC-MS

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026