HealthyBIOPNCT02865278
Bioavailability of the Polyphenols Contained in a Red Grape Extract-based Drink and Their Metabolic Effects
A study testing Standard meal in people with Healthy, run by Federico II University.
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). Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Standard meal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI >25 and <35 kg/m2
- Total cholesterol <250 mg/dl
- Triglyceride < 200 mg/dl.
- Fasting glucose <100 mg/dl
Who cannot join
- 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
About this study
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
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.
- Conditions
- Healthy
- Being tested
- Standard meal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard mealOther
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 group | Role | What they receive |
|---|---|---|
| Polyphenol-rich drink | Experimental | 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. Receives: Other: Standard meal |
| Placebo drink | Placebo comparator | The participants consume the control drink.After 3 hours they consume a standard meal to evaluate the metabolic response after a placebo. Receives: Other: Standard meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenolic metabolites in urine
GCxGC-MS
Measured: 48 hours
Secondary outcomes (4)
Glucose response
Enzymatic colorimetric methods
Measured: 8 hours
Inflammation
Multiplex Detection Immunoassays
Measured: 8 hours
Oxidative stress (urinary isoprostanes)
EIA
Measured: 8 hours
Triglyceride response
Enzymatic colorimetric methods
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startMar 2016
- Primary completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rivellese angela, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865278
- Sponsor's protocol ID
- 29/16
- Acronym
- BIOP
- Status last verified
- Jul 2016
- First submitted
- 15 Jul 2016
- Last updated
- 12 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 30573355
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02865278
- Acronym / sponsor ID
- BIOP / 29/16
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jul 2016 (actual)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polyphenol-rich drink | Experimental | Other: Standard mealThe 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 comparator | Other: Standard mealThe participants consume the control drink.After 3 hours they consume a standard meal to evaluate the metabolic response after a placebo. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI >25 and <35 kg/m2
- Total cholesterol <250 mg/dl
- Triglyceride < 200 mg/dl.
- Fasting glucose <100 mg/dl
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard mealThe 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. | Other | Placebo drink, Polyphenol-rich drink |
Primary outcome
Phenolic metabolites in urine
Time frame: 48 hours
GCxGC-MS
4 secondary outcomes
Glucose response
Time frame: 8 hours
Inflammation
Time frame: 8 hours
Oxidative stress (urinary isoprostanes)
Time frame: 8 hours
Triglyceride response
Time frame: 8 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2016.
- Derived from this study: PubMed 30573355Costabile 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Standard meal in people with Healthy, run by Federico II University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phenolic metabolites in urine (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02865278, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2016.