Subjects With Abdominal ObesityPOME-GRAPE-1NCT02710461
Grape and Pomegranate Polyphenols in Postprandial Glucose and Related Parameters
A study testing Mixture of grape pomace and pomegranate pomace in people with Subjects With Abdominal Obesity, run by National Research Council, Spain at 1 site in Spain.
Trial summary
The aim of this is study is to evaluate the acute effect of grape and pomegranate polyphenols in the modulation of markers of metabolic syndrome. Most of the previous works about polyphenols have only considered a fraction of polyphenols, i.e., extractable polyphenols. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Subjects With Abdominal Obesity
- What is being tested?
- Mixture of grape pomace and pomegranate pomace
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2016to Dec 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Abdominal perimeter ≥102 cm. for male participants and ≥88 cm for female participants.
- Subjects presenting some or several of these characteristics will be prioritized:
- Fasting glucose values between 110-128 mg/dL. Triglycerides = 150-195 mg/dL. HDL-cholesterol: < 50 mg/dL men, < 40 mg/dL women. Blood pressure: systolic > 130 mm Hg; diastolic > 85 mm Hg.
Who cannot join
- Subjects taking drugs for hyperglycaemia, hypertension or hypercholesterolaemia.
- Volunteers participating in other studies or weight loss plans.
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Institute of Food Science, Technology and Nutrition, National Research Council (ICTAN-CSIC)
Madrid, Madrid, 28040
About this study
Official title: Acute Effects of Grape and Pomegranate Polyphenols as Modulators of Metabolic Syndrome in Humans
The aim of this is study is to evaluate the acute effect of grape and pomegranate polyphenols in the modulation of markers of metabolic syndrome. Most of the previous works about polyphenols have only considered a fraction of polyphenols, i.e., extractable polyphenols. As a consequence, an important amount of dietary polyphenols, the so-called non-extractable polyphenols are ignored. In contrast, the effect of both extractable and non-extractable polyphenols will be considered in this study. Furthermore, the effect of both polyphenols as present in the food matrix and metabolites derived from microbial fermentation will be evaluated.
- Conditions
- Subjects With Abdominal Obesity
- Being tested
- Mixture of grape pomace and pomegranate pomace
- Keywords
- Polyphenols, Grape, Pomegranate, Metabolic syndrome, Abdominal obesity, Postprandial glucose, Insulin resistance
- Medical subject headings
- Metabolic Syndrome, Obesity, Abdominal, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixture of grape pomace and pomegranate pomaceDietary supplement
Oral Glucose Tolerance Test
Mixture of grape pomace and pomegranate pomaceDietary supplement
Oral Glucose Tolerance Test right after taking the mixture of grape and pomegranate polyphenols
Mixture of grape pomace and pomegranate pomaceDietary supplement
Oral Glucose Tolerance Test ten hours after taking the mixture of grape and pomegranate polyphenols
| Study group | Role | What they receive |
|---|---|---|
| Subjects with abdominal obesity | Experimental | Intervention with grape pomace and pomegranate pomace Receives: Dietary Supplement: Mixture of grape pomace and pomegranate pomace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glucose
Changes in blood glucose response in treatments B and C will be compared with the baseline results obtained in treatment A. This will be evaluated by area under the curve (AUC) 0-120 min after an Oral Glucose Tolerance Test (OGTT)
Measured: 0-120 min.
Secondary outcomes (5)
Postprandial insulin
Changes in blood insulin response in treatments B and C will be compared with the baseline results obtained in treatment A. This will be evaluated by area under the curve (AUC) 0-120 min after an Oral Glucose Tolerance Test (OGTT)
Measured: 0-120 min.
Postprandial uric acid
Changes in blood uric acid response in treatments B and C will be compared with the baseline results obtained in treatment A. This will be evaluated by area under the curve (AUC) 0-120 min after an Oral Glucose Tolerance Test (OGTT)
Measured: 0-120 min.
Polyphenol metabolites
Urinary polyphenol metabolites will be determined in samples collected in the period 0-180 min. of each intervention.
Measured: 0-180 min.
Urinary uric acid
Urinary uric acid will be determined in samples collected in the period 0-180 min. of each intervention.
Measured: 0-180 min.
Satiety
A satiety test, including 10 items, will be provided at different time points during the period 0-120 min. of each intervention.
Measured: 120 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjects With Abdominal ObesityStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Council, Spain
- Sponsor type
- Other government
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Responsible party
- Principal investigator, Jara Pérez-Jiménez, National Research Council, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02710461
- Sponsor's protocol ID
- AGL2014-55102-JIN_1
- Acronym
- POME-GRAPE-1
- Status last verified
- Mar 2017
- First submitted
- 12 Mar 2016
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Grape and Pomegranate Polyphenols as Modulators of Metabolic Syndrome in Humans
- ClinicalTrials.gov ID
- NCT02710461
- Acronym / sponsor ID
- POME-GRAPE-1 / AGL2014-55102-JIN_1
- Conditions
- Subjects With Abdominal Obesity
- Keywords
- Polyphenols, Grape, Pomegranate, Metabolic syndrome, Abdominal obesity, Postprandial glucose, Insulin resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Research Council, SpainOther government
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Study start
- Mar 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 16 Mar 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.
The aim of this is study is to evaluate the acute effect of grape and pomegranate polyphenols in the modulation of markers of metabolic syndrome. Most of the previous works about polyphenols have only considered a fraction of polyphenols, i.e., extractable polyphenols. As a consequence, an important amount of dietary polyphenols, the so-called non-extractable polyphenols are ignored. In contrast, the effect of both extractable and non-extractable polyphenols will be considered in this study. Furthermore, the effect of both polyphenols as present in the food matrix and metabolites derived from microbial fermentation will be evaluated.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with abdominal obesity | Experimental | Dietary Supplement: Mixture of grape pomace and pomegranate pomaceIntervention with grape pomace and pomegranate pomace |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Abdominal perimeter ≥102 cm. for male participants and ≥88 cm for female participants.
- Subjects presenting some or several of these characteristics will be prioritized:
- Fasting glucose values between 110-128 mg/dL. Triglycerides = 150-195 mg/dL. HDL-cholesterol: < 50 mg/dL men, < 40 mg/dL women. Blood pressure: systolic > 130 mm Hg; diastolic > 85 mm Hg.
Key exclusion criteria (3 listed)
- Subjects taking drugs for hyperglycaemia, hypertension or hypercholesterolaemia.
- Volunteers participating in other studies or weight loss plans.
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| Mixture of grape pomace and pomegranate pomaceOral Glucose Tolerance Test | Dietary supplement | Subjects with abdominal obesity |
| Mixture of grape pomace and pomegranate pomaceOral Glucose Tolerance Test right after taking the mixture of grape and pomegranate polyphenols | Dietary supplement | Subjects with abdominal obesity |
| Mixture of grape pomace and pomegranate pomaceOral Glucose Tolerance Test ten hours after taking the mixture of grape and pomegranate polyphenols | Dietary supplement | Subjects with abdominal obesity |
Primary outcome
Postprandial glucose
Time frame: 0-120 min.
Changes in blood glucose response in treatments B and C will be compared with the baseline results obtained in treatment A. This will be evaluated by area under the curve (AUC) 0-120 min after an Oral Glucose Tolerance Test (OGTT)
5 secondary outcomes
Postprandial insulin
Time frame: 0-120 min.
Postprandial uric acid
Time frame: 0-120 min.
Polyphenol metabolites
Time frame: 0-180 min.
Urinary uric acid
Time frame: 0-180 min.
Satiety
Time frame: 120 min.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
Related trials for Subjects With Abdominal Obesity
Not yet recruiting
INNUPREC (Nutrigenetic Intervention for the Prevention of Cardiovascular Disease)
Abdominal Obesity
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mixture of grape pomace and pomegranate pomace in people with Subjects With Abdominal Obesity, run by National Research Council, Spain at 1 site in Spain.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postprandial glucose (time frame: 0-120 min.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2017.