Grape and Pomegranate Polyphenols in Postprandial Glucose and Related Parameters

NCT ID: NCT02710461

Last Updated: 2017-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2016-12-31

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.

Conditions

Subjects With Abdominal Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Subjects with abdominal obesity

Intervention with grape pomace and pomegranate pomace

Group Type: EXPERIMENTAL

Mixture of grape pomace and pomegranate pomace

Intervention Type: DIETARY_SUPPLEMENT

Oral Glucose Tolerance Test

Mixture of grape pomace and pomegranate pomace

Intervention Type: DIETARY_SUPPLEMENT

Oral Glucose Tolerance Test right after taking the mixture of grape and pomegranate polyphenols

Mixture of grape pomace and pomegranate pomace

Intervention Type: DIETARY_SUPPLEMENT

Oral Glucose Tolerance Test ten hours after taking the mixture of grape and pomegranate polyphenols

Interventions

Mixture of grape pomace and pomegranate pomace

Oral Glucose Tolerance Test

Intervention Type: DIETARY_SUPPLEMENT

Mixture of grape pomace and pomegranate pomace

Oral Glucose Tolerance Test right after taking the mixture of grape and pomegranate polyphenols

Intervention Type: DIETARY_SUPPLEMENT

Mixture of grape pomace and pomegranate pomace

Oral Glucose Tolerance Test ten hours after taking the mixture of grape and pomegranate polyphenols

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministerio de Economía y Competitividad, Spain

OTHER_GOV

Sponsor Role: collaborator

National Research Council, Spain

OTHER_GOV

Sponsor Role: lead

Responsible Party

Jara Pérez-Jiménez

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Institute of Food Science, Technology and Nutrition, National Research Council (ICTAN-CSIC)

Madrid, Madrid, Spain

Countries

Spain

Other Identifiers

AGL2014-55102-JIN_1

Identifier Type: -

Identifier Source: org_study_id