Subjects at Cardiometabolic Risk
Conditions
Keywords
Polyphenols, Metabolic syndrome, Cardiometabolic risk, Grape pomace, Postprandial glucose, Insulin resistance, Obesity
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.
Interventions
DIETARY_SUPPLEMENTGRAPOM
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.
Sponsors
University of the Basque Country (UPV/EHU)
National Research Council, Spain
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Blood C reactive protein | Up to five months | Changes of blood C reactive protein as result of long-term supplementation with grape pomace (GRAPOM). |
| Blood fibrinogen | Up to five months | Changes of blood fibrinogen 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). |
| Iron metabolism | Up to six months | Changes of blood markers of iron metabolism 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). |
| Urine uric acid | Up to six months | Changes of urine uric acid 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 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). |
| Body fat | Up to seven months | Changes of body fat 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). |
| 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). |
| 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). |
Countries
Spain
Outcome results
None listed