- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02710461
Grape and Pomegranate Polyphenols in Postprandial Glucose and Related Parameters (POME-GRAPE-1)
March 27, 2017 updated by: Jara Pérez-Jiménez, National Research Council, Spain
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Madrid, Spain, 28040
- Institute of Food Science, Technology and Nutrition, National Research Council (ICTAN-CSIC)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Subjects taking drugs for hyperglycaemia, hypertension or hypercholesterolaemia.
- Volunteers participating in other studies or weight loss plans.
- Pregnant or breastfeeding women.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Subjects with abdominal obesity
Intervention with grape pomace and pomegranate pomace
|
Oral Glucose Tolerance Test
Oral Glucose Tolerance Test right after taking the mixture of grape and pomegranate polyphenols
Oral Glucose Tolerance Test ten hours after taking the mixture of grape and pomegranate polyphenols
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
0-120 min.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postprandial insulin
Time Frame: 0-120 min.
|
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)
|
0-120 min.
|
Postprandial uric acid
Time Frame: 0-120 min.
|
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)
|
0-120 min.
|
Polyphenol metabolites
Time Frame: 0-180 min.
|
Urinary polyphenol metabolites will be determined in samples collected in the period 0-180 min. of each intervention.
|
0-180 min.
|
Urinary uric acid
Time Frame: 0-180 min.
|
Urinary uric acid will be determined in samples collected in the period 0-180 min. of each intervention.
|
0-180 min.
|
Satiety
Time Frame: 120 min.
|
A satiety test, including 10 items, will be provided at different time points during the period 0-120 min. of each intervention.
|
120 min.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2016
Primary Completion (Actual)
October 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
March 12, 2016
First Submitted That Met QC Criteria
March 12, 2016
First Posted (Estimate)
March 16, 2016
Study Record Updates
Last Update Posted (Actual)
March 28, 2017
Last Update Submitted That Met QC Criteria
March 27, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AGL2014-55102-JIN_1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Subjects With Abdominal Obesity
-
National Taiwan University HospitalUnknownAbdominal Obesity Metabolic Syndrome | Subjects With Poor Fitness StatusTaiwan
-
Ben-Gurion University of the NegevUniversity of Leipzig; Harvard School of Public Health (HSPH)CompletedMen With Mild Abdominal ObesityIsrael
-
Yuhan CorporationCompletedAtopic Healthy Subjects | Adult Subjects With Mild Allergic DiseasesKorea, Republic of
-
Yuhan CorporationRecruitingAtopic Healthy Subjects | Adult Subjects With Mild Allergic DiseasesKorea, Republic of
-
Topcon Medical Systems, Inc.CompletedSubjects Presenting With Normal or With Ocular PathologyUnited States
-
Coloplast A/SCompletedSubjects With an IleostomyDenmark
-
Saladax Biomedical, Inc.Not yet recruitingSubjects Treated With Busulfan
-
Central Clinical Hospital #1 of LLC Russian RailwaysUnknownAdult Subjects Undergoing Abdominal Surgery Under General AnesthesiaRussian Federation
-
Trisakti UniversityIndonesia University; Duke-NUS Graduate Medical School; BioGaia ABActive, not recruitingHealthy Subjects With Fixed OrthodonticsIndonesia
-
Shanghai Vinnerna Biosciences Co., Ltd.Sponsor GmbHCompletedElderly Subjects With Underlying DiseasesChina
Clinical Trials on Mixture of grape pomace and pomegranate pomace
-
PepsiCo Global R&DCompletedDigestive HealthUnited States
-
Centro de Estudios en Alimentos ProcesadosQuadram Institute Bioscience; University of TalcaCompletedCardiovascular DiseasesChile
-
Pontificia Universidad Catolica de ChileCompletedOxidative Stress | Metabolic Syndrome XChile
-
PepsiCo Global R&DCompletedGlycemic ResponseUnited States
-
University of CopenhagenCentral Jutland Regional Hospital; Technical University of DenmarkCompletedCardiovascular DiseasesDenmark
-
Instituto de Ciencia y Tecnología de Alimentos...Completed
-
Instituto de Ciencia y Tecnología de Alimentos...Completed
-
Spanish National Research CouncilRecruiting
-
University of California, DavisCompletedInflammation | Obesity | Cardiovascular Disease | Oxidative StressUnited States
-
National Research Council, SpainIMDEA Food; CEIP (primary school) Jara Carrillo (Alcantarilla, Murcia, Spain); IES (secondary school) Alcántara (Alcantarilla, Murcia, Spain)CompletedGenotype, Metabotype and Dietary HabitsSpain