Grape and Pomegranate Polyphenols in Postprandial Glucose and Related Parameters (POME-GRAPE-1)

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: Subjects With Abdominal Obesity
• Intervention / Treatment: Dietary supplement: Mixture of grape pomace and pomegranate pomace; Dietary supplement: Mixture of grape pomace and pomegranate pomace; Dietary supplement: Mixture of grape pomace and pomegranate pomace

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Institute of Food Science, Technology and Nutrition, National Research Council (ICTAN-CSIC)

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Subjects with abdominal obesity; Intervention with grape pomace and pomegranate pomace

Dietary supplement: Mixture of grape pomace and pomegranate pomace; Oral Glucose Tolerance Test; Dietary supplement: Mixture of grape pomace and pomegranate pomace; Oral Glucose Tolerance Test right after taking the mixture of grape and pomegranate polyphenols; Dietary supplement: Mixture of grape pomace and pomegranate pomace; 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	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	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	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	Urinary polyphenol metabolites will be determined in samples collected in the period 0-180 min. of each intervention.	0-180 min.
Urinary uric acid	Urinary uric acid will be determined in samples collected in the period 0-180 min. of each intervention.	0-180 min.
Satiety	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

• Sponsor: National Research Council, Spain
• Collaborators: Ministerio de Economía y Competitividad, Spain

Study record dates

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: Metabolic syndrome; Insulin resistance; Pomegranate; Polyphenols; Abdominal obesity; Postprandial glucose; Grape
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Obesity; Obesity, Abdominal
• Other Study ID Numbers: AGL2014-55102-JIN_1