Clinical trial NCT03076463: Grape Pomace Polyphenols and Cardiometabolic Risk
Official title: Long-term Effects of Grape Polyphenols as Modulators of Metabolic Syndrome in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subjects at Cardiometabolic Risk
Keywords: Polyphenols
Metabolic syndrome
Cardiometabolic risk
Grape pomace
Postprandial glucose
Insulin resistance
Obesity
Lead sponsor: National Research Council, Spain
Sponsor class: OTHER_GOV
Collaborators: name: University of the Basque Country (UPV/EHU)
First posted: 2017-03-10
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fasting insulin
timeFrame: Up to three months
measure: Fasting glucose
timeFrame: Up to three months
Secondary outcomes:
measure: Postprandial glucose
timeFrame: Up to four months
measure: Postprandial insulin
timeFrame: Up to four months
measure: Blood pressure
timeFrame: Up to four months
measure: Blood cholesterol (total, HDL, LDL)
timeFrame: Up to four months
measure: Blood triglycerides
timeFrame: Up to four months
measure: Blood C reactive protein
timeFrame: Up to five months
measure: Blood fibrinogen
timeFrame: Up to five months
measure: Blood uric acid
timeFrame: Up to five months
measure: Iron metabolism
timeFrame: Up to six months
measure: Blood polyphenols
timeFrame: Up to six months
measure: Urine uric acid
timeFrame: Up to six months
measure: Urine polyphenols
timeFrame: Up to seen months
measure: Body weight
timeFrame: Up to three months
measure: Body fat
timeFrame: Up to seven months
measure: miRNA expression
timeFrame: Up to eight months
measure: Profile of fecal microbiota
timeFrame: Up to nine months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Institute of Food Science, Technology and Nutrition (ICTAN-CSIC)
Study officials:
References: