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Completed

NCT Number: NCT02710461

Grape and Pomegranate Polyphenols in Postprandial Glucose and Related Parameters

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.

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Key information

Conditions

Subjects With Abdominal Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Madrid, 28040, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mixture of grape pomace and pomegranate pomace

Dietary Supplement

Oral Glucose Tolerance Test

Primary outcomes

  1. Postprandial glucose

    Time frame: 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 outcomes

  1. Postprandial insulin

    Time frame: 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)

  2. Postprandial uric acid

    Time frame: 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)

  3. Polyphenol metabolites

    Time frame: 0-180 min.

    Urinary polyphenol metabolites will be determined in samples collected in the period 0-180 min. of each intervention.

  4. Urinary uric acid

    Time frame: 0-180 min.

    Urinary uric acid will be determined in samples collected in the period 0-180 min. of each intervention.

  5. Satiety

    Time frame: 120 min.

    A satiety test, including 10 items, will be provided at different time points during the period 0-120 min. of each intervention.

Sponsors and collaborators

Lead sponsor

National Research Council, Spain

Other Gov

Collaborators

  • Ministerio de Economía y Competitividad, Spain

Registry information

Official study title

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

Acronym: POME-GRAPE-1

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 16, 2016
Registry last updated
Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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