Overview

This trial is active, not recruiting.

Condition subjects with abdominal obesity
Treatments mixture of grape pomace and pomegranate pomace
Sponsor National Research Council, Spain
Collaborator Ministry of Economy and Competitiveness (MINNECO), Spain
Start date March 2016
End date October 2016
Trial size 20 participants
Trial identifier NCT02710461, AGL2014-55102-JIN_1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
Intervention with grape pomace and pomegranate pomace
mixture of grape pomace and pomegranate pomace
Oral Glucose Tolerance Test
mixture of grape pomace and pomegranate pomace
Oral Glucose Tolerance Test right after taking the mixture of grape and pomegranate polyphenols
mixture of grape pomace and pomegranate pomace
Oral Glucose Tolerance Test ten hours after taking the mixture of grape and pomegranate polyphenols

Primary Outcomes

Measure
Postprandial glucose
time frame: 0-120 min.

Secondary Outcomes

Measure
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.

Eligibility Criteria

Male or female participants from 40 years up to 60 years old.

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.

Additional Information

Official title Acute Effects of Grape and Pomegranate Polyphenols as Modulators of Metabolic Syndrome in Humans
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by National Research Council, Spain.