Grape and Pomegranate Polyphenols in Postprandial Glucose and Related Parameters (POME-GRAPE-1)
Primary Purpose
Subjects With Abdominal Obesity
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Mixture of grape pomace and pomegranate pomace
Mixture of grape pomace and pomegranate pomace
Mixture of grape pomace and pomegranate pomace
Sponsored by
About this trial
This is an interventional basic science trial for Subjects With Abdominal Obesity focused on measuring Polyphenols, Grape, Pomegranate, Metabolic syndrome, Abdominal obesity, Postprandial glucose, Insulin resistance
Eligibility Criteria
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.
Sites / Locations
- Institute of Food Science, Technology and Nutrition, National Research Council (ICTAN-CSIC)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subjects with abdominal obesity
Arm Description
Intervention with grape pomace and pomegranate pomace
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
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)
Polyphenol metabolites
Urinary polyphenol metabolites will be determined in samples collected in the period 0-180 min. of each intervention.
Urinary uric acid
Urinary uric acid will be determined in samples collected in the period 0-180 min. of each intervention.
Satiety
A satiety test, including 10 items, will be provided at different time points during the period 0-120 min. of each intervention.
Full Information
NCT ID
NCT02710461
First Posted
March 12, 2016
Last Updated
March 27, 2017
Sponsor
National Research Council, Spain
Collaborators
Ministerio de Economía y Competitividad, Spain
1. Study Identification
Unique Protocol Identification Number
NCT02710461
Brief Title
Grape and Pomegranate Polyphenols in Postprandial Glucose and Related Parameters
Acronym
POME-GRAPE-1
Official Title
Acute Effects of Grape and Pomegranate Polyphenols as Modulators of Metabolic Syndrome in Humans
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Research Council, Spain
Collaborators
Ministerio de Economía y Competitividad, Spain
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subjects With Abdominal Obesity
Keywords
Polyphenols, Grape, Pomegranate, Metabolic syndrome, Abdominal obesity, Postprandial glucose, Insulin resistance
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects with abdominal obesity
Arm Type
Experimental
Arm Description
Intervention with grape pomace and pomegranate pomace
Intervention Type
Dietary Supplement
Intervention Name(s)
Mixture of grape pomace and pomegranate pomace
Intervention Description
Oral Glucose Tolerance Test
Intervention Type
Dietary Supplement
Intervention Name(s)
Mixture of grape pomace and pomegranate pomace
Intervention Description
Oral Glucose Tolerance Test right after taking the mixture of grape and pomegranate polyphenols
Intervention Type
Dietary Supplement
Intervention Name(s)
Mixture of grape pomace and pomegranate pomace
Intervention Description
Oral Glucose Tolerance Test ten hours after taking the mixture of grape and pomegranate polyphenols
Primary Outcome Measure Information:
Title
Postprandial glucose
Description
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)
Time Frame
0-120 min.
Secondary Outcome Measure Information:
Title
Postprandial insulin
Description
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)
Time Frame
0-120 min.
Title
Postprandial uric acid
Description
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)
Time Frame
0-120 min.
Title
Polyphenol metabolites
Description
Urinary polyphenol metabolites will be determined in samples collected in the period 0-180 min. of each intervention.
Time Frame
0-180 min.
Title
Urinary uric acid
Description
Urinary uric acid will be determined in samples collected in the period 0-180 min. of each intervention.
Time Frame
0-180 min.
Title
Satiety
Description
A satiety test, including 10 items, will be provided at different time points during the period 0-120 min. of each intervention.
Time Frame
120 min.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Institute of Food Science, Technology and Nutrition, National Research Council (ICTAN-CSIC)
City
Madrid
ZIP/Postal Code
28040
Country
Spain
12. IPD Sharing Statement
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Grape and Pomegranate Polyphenols in Postprandial Glucose and Related Parameters
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