Bioavailability of the Polyphenols Contained in a Red Grape Extract-based Drink and Their Metabolic Effects
BIOP
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
1 other identifier
interventional
10
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 15, 2016
CompletedFirst Posted
Study publicly available on registry
August 12, 2016
CompletedAugust 12, 2016
July 1, 2016
4 months
July 15, 2016
August 9, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Phenolic metabolites in urine
GCxGC-MS
48 hours
Secondary Outcomes (4)
Glucose response
8 hours
Inflammation
8 hours
Oxidative stress (urinary isoprostanes)
8 hours
Triglyceride response
8 hours
Study Arms (2)
Polyphenol-rich drink
EXPERIMENTALThe 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.
Placebo drink
PLACEBO COMPARATORThe participants consume the control drink.After 3 hours they consume a standard meal to evaluate the metabolic response after a placebo.
Interventions
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.
Eligibility Criteria
You may qualify if:
- BMI \>25 and \<35 kg/m2
- Total cholesterol \<250 mg/dl
- Triglyceride \< 200 mg/dl.
- Fasting glucose \<100 mg/dl
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Costabile G, Vitale M, Luongo D, Naviglio D, Vetrani C, Ciciola P, Tura A, Castello F, Mena P, Del Rio D, Capaldo B, Rivellese AA, Riccardi G, Giacco R. Grape pomace polyphenols improve insulin response to a standard meal in healthy individuals: A pilot study. Clin Nutr. 2019 Dec;38(6):2727-2734. doi: 10.1016/j.clnu.2018.11.028. Epub 2018 Dec 7.
PMID: 30573355DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full professor
Study Record Dates
First Submitted
July 15, 2016
First Posted
August 12, 2016
Study Start
March 1, 2016
Primary Completion
July 1, 2016
Last Updated
August 12, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will not share