Grape and Pomegranate Polyphenols in Postprandial Glucose and Related Parameters

Acute Effects of Grape and Pomegranate Polyphenols as Modulators of Metabolic Syndrome in Humans

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02710461

Acronym

POME-GRAPE-1

Enrollment

Registered

2016-03-16

Start date

2016-03-31

Completion date

2016-12-31

Last updated

2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subjects With Abdominal Obesity

Keywords

Polyphenols, Grape, Pomegranate, Metabolic syndrome, Abdominal obesity, Postprandial glucose, Insulin resistance

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.

Interventions

DIETARY_SUPPLEMENTMixture of grape pomace and pomegranate pomace

Oral Glucose Tolerance Test

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)
Polyphenol metabolites	0-180 min.	Urinary polyphenol metabolites will be determined in samples collected in the period 0-180 min. of each intervention.
Urinary uric acid	0-180 min.	Urinary uric acid will be determined in samples collected in the period 0-180 min. of each intervention.
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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026