Grape Pomace Polyphenols and Cardiometabolic Risk

Study Overview
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Brief Summary
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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
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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.

Official Title
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Long-term Effects of Grape Polyphenols as Modulators of Metabolic Syndrome in Humans

Conditions
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Subjects at Cardiometabolic Risk

Intervention / Treatment
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* Dietary Supplement: GRAPOM


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: GRAPOM: dried and milled grape pomaces. CTR: control period. All the subjects will pass the two periods: one half will do the CTRL period followed by the GRAPOM period, and the other half will do it inversely. The assignment to each order will be done randomly. Both period will be separated by a four weeks washing period.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GRAPOM<br>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 | Dietary Supplement: GRAPOM<br>* 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.<br>|
| No Intervention: CTR<br>Follow-up for 6 weeks without intervention. Samples will be collected at the beginning and the end of this period | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting insulin | Changes of blood insulin fasting levels as result of long-term supplementation with grape pomace (GRAPOM). | Up to three months | 
| Fasting glucose | Changes of blood glucose fasting levels as result of long-term supplementation with grape pomace (GRAPOM). | Up to three months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Polyphenols, Metabolic syndrome, Cardiometabolic risk, Grape pomace, Postprandial glucose, Insulin resistance