Grape Pomace Polyphenols and Cardiometabolic Risk

Not Applicable

Completed

• Conditions: Subjects at Cardiometabolic Risk
• Interventions: Dietary Supplement: GRAPOM

• Registration Number: NCT03076463
• Lead Sponsor: National Research Council, Spain

Brief Summary

The aim of this is study is to evaluate the long-term effects of grape 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. Also, studies on the long-term effect of grape polyphenol on markers of metabolic syndrome have been mostly conducted in animals, so clinical trials on this topic are needed.

Detailed Description

Fifty supposedly healthy volunteers with at least two cardiometabolic risk factors were recruited. The cardiometabolic risk factors used to select the subjects are described below.

The whole intervention will be divided in 2 periods, control (CTR) and dried and milled grape pomace (GRAPOM). The two periods will have a duration of 6 weeks. During the CTR period, subjects will follow their normal dietary habits and samples will be collected at the beginning and at the end. No proper placebo could be found for the product, so this CTR period was chosen. During the GRAPOM period, the subjects will daily consume 8 g of the product solved in water and samples will be collected at the beginning and at the end.

Study Timeline

• Study First Submitted: 2017-02-26
• Study First Submitted QC: 2017-03-06
• Study Start: 2017-03-10
• Study First Posted: 2017-03-10
• Primary Completion: 2017-07-07
• Study Completion: 2017-12-20
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-04
• Last Update Posted: 2018-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

At least two of the following requirements:

• BMI ≥ 25 kg/m2.
• Fasting glucose values ≥ 100 mg/dL.
• Triglycerides ≥ 150 mg/dL.
• HDL-cholesterol: ≤ 50 mg/dL women, ≤ 40 mg/dL men.
• Blood pressure: systolic ≥ 130 mm Hg or diastolic ≥ 85 mm Hg.

Exclusion Criteria

• Subjects with a pharmaceutical treatment set to modify blood pressure, lipid profile or glucose.
• Volunteers participating in other studies or weight loss plans.
• Pregnant or breastfeeding women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GRAPOM	GRAPOM	Daily consumption for 6 weeks of 10 g of dried and milled grape pomaces solved in water. Samples will be collected at the beginning and the end of this period

Primary Outcome Measures

Name	Time	Method
Fasting insulin	Up to three months	Changes of blood insulin fasting levels as result of long-term supplementation with grape pomace (GRAPOM).
Fasting glucose	Up to three months	Changes of blood glucose fasting levels as result of long-term supplementation with grape pomace (GRAPOM).

Secondary Outcome Measures

Name	Time	Method
Blood fibrinogen	Up to five months	Changes of blood fibrinogen as result of long-term supplementation with grape pomace (GRAPOM).
Postprandial insulin	Up to four months	Changes of blood insulin response after an oral glucose load as result of long-term supplementation with grape pomace (GRAPOM).
Blood C reactive protein	Up to five months	Changes of blood C reactive protein as result of long-term supplementation with grape pomace (GRAPOM).
Postprandial glucose	Up to four months	Changes of blood glucose response after an oral glucose load as result of long-term supplementation with grape pomace (GRAPOM).
Blood pressure	Up to four months	Changes of blood pressure as result of long-term supplementation with grape pomace (GRAPOM).
Blood cholesterol (total, HDL, LDL)	Up to four months	Changes of blood cholesterol (total, HDL, LDL) as result of long-term supplementation with grape pomace (GRAPOM).
Blood triglycerides	Up to four months	Changes of blood triglycerides as result of long-term supplementation with grape pomace (GRAPOM).
Iron metabolism	Up to six months	Changes of blood markers of iron metabolism as result of long-term supplementation with grape pomace (GRAPOM).
miRNA expression	Up to eight months	Changes of blood expression of selected miRNA as result of long-term supplementation with grape pomace (GRAPOM).
Blood uric acid	Up to five months	Changes of blood uric acid as result of long-term supplementation with grape pomace (GRAPOM).
Profile of fecal microbiota	Up to nine months	Changes of fecal microbiota as result of long-term supplementation with grape pomace (GRAPOM).
Blood polyphenols	Up to six months	Changes of blood polyphenols as result of long-term supplementation with grape pomace (GRAPOM).
Urine polyphenols	Up to seen months	Changes of urine polyphenols as result of long-term supplementation with grape pomace (GRAPOM).
Body fat	Up to seven months	Changes of body fat as result of long-term supplementation with grape pomace (GRAPOM).
Urine uric acid	Up to six months	Changes of urine uric acid as result of long-term supplementation with grape pomace (GRAPOM).
Body weight	Up to three months	Changes of body weight (measured at a body-impedance equipment) as result of long-term supplementation with grape pomace (GRAPOM).

Trial Locations

Locations (1)

Institute of Food Science, Technology and Nutrition (ICTAN-CSIC); 🇪🇸 Madrid, Spain