Grape and Pomegranate Polyphenols in Postprandial Glucose and Related Parameters

Not Applicable

Completed

• Conditions: Subjects With Abdominal Obesity
• Interventions: Dietary Supplement: Mixture of grape pomace and pomegranate pomace

• Registration Number: NCT02710461
• Lead Sponsor: National Research Council, Spain

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-12
• Study First Submitted QC: 2016-03-12
• Study First Posted: 2016-03-16
• Primary Completion: 2016-10
• Study Completion: 2016-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects with abdominal obesity	Mixture of grape pomace and pomegranate pomace	Intervention with grape pomace and pomegranate pomace

Primary Outcome Measures

Name	Time	Method
Postprandial glucose	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)

Secondary Outcome Measures

Name	Time	Method
Urinary uric acid	0-180 min.	Urinary uric acid will be determined in samples collected in the period 0-180 min. of each intervention.
Polyphenol metabolites	0-180 min.	Urinary polyphenol metabolites will be determined in samples collected in the period 0-180 min. of each intervention.
Postprandial insulin	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)
Postprandial uric acid	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)
Satiety	120 min.	A satiety test, including 10 items, will be provided at different time points during the period 0-120 min. of each intervention.

Trial Locations

Locations (1)

Institute of Food Science, Technology and Nutrition, National Research Council (ICTAN-CSIC); 🇪🇸 Madrid, Spain