Grape Polyphenols and Metabolic Syndrome (PolyGrape)
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|ClinicalTrials.gov Identifier: NCT04053569|
Recruitment Status : Not yet recruiting
First Posted : August 12, 2019
Last Update Posted : August 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome, Protection Against||Dietary Supplement: Table Grape supplement||Not Applicable|
Purified polyphenols extracted by table grape can decrease cell proliferation in vitro and exert anti-atherosclerotic and antithrombotic activities, regulating endothelial function. Literature studies have already evaluated the cytostatic and apoptotic effects produced by table grape extracts from different cultivars, demonstrating a different behavior based on extract composition. The beneficial effects of polyphenols have been attributed exclusively to their direct antioxidant action; however, in recent years it has emerged that polyphenols can interact with intracellular signaling mechanisms, modulating the activity of transcription factors involved in cell lipid metabolism. Lipidomic analysis studies the lipids in a "dynamic" way, monitoring the changes in membrane phospholipids content, caused by inflammation, stress, or malnutrition. These changes can also affect the cellular and plasmatic prothrombotic potential, which results altered in metabolic diseases. Recently, alterations in erythrocytes lipidomic profile have been detected in subjects with steatosis. Moreover, in patients with colorectal cancer patients, the presence of metastases at the time of surgery was associated with an altered profile of fatty acids in the membrane of colonic tissue cells.
Moreover, data in literature show how diet and functional foods can modify serum lipid content, in particular, an important role in the onset of dysmetabolic diseases is undoubtedly played by the different fractions of Low-Density Lipoproteins (LDL). The presence of smaller LDL fractions in the serum, such as fraction 3 and fraction 4, has been associated with the onset of cardiovascular disease and myocardial infarctions. Therefore, understanding the molecular mechanisms underlying the effects of nutraceuticals is essential to develop prevention and intervention strategies on subjects at risk for metabolic syndrome.
On this basis, the aim of this study is the evaluation of possible changes happening in lipidomic profile, plasma antioxidant activity and plasma prothrombotic potential induced by a diet enriched with table grape polyphenols in subjects with metabolic syndrome.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, single-blind clinical trial|
|Masking Description:||Single (participant)|
|Official Title:||Effects of Polyphenols From a Table Grape on the Lipidomic Profile and Serum LDL Fractions: Possible Implications in the Metabolic Syndrome|
|Estimated Study Start Date :||October 1, 2019|
|Estimated Primary Completion Date :||November 1, 2020|
|Estimated Study Completion Date :||November 1, 2021|
Experimental: Diet with table grape
Table grape (5g/Kg) administered for four weeks with dietary recommendations. A strict restriction of fruits and the limitation of other foods containing polyphenols will be necessary.
Dietary Supplement: Table Grape supplement
5g/Kg of table grape for four weeks with dietary recommendations along with a strict restriction of fruits and limitation of other foods containing polyphenols.
No Intervention: Specific dietary advice
Dietary recommendations (such as limitation of alcohol, caffeine), and low consumption of fruits.
- Changes in serum concentrations (mg/dL) of cholesterol, triglycerides, glucose [ Time Frame: Before the start of the study (time 0), after four weeks (time 1) and after eight weeks (time 2) ]Blood samples will be taken after at least 12 hours of fasting and the concentrations of cholesterol. triglycerides, and glucose will be assessed according to the standard laboratory methods (commercially available kits).
- Changes in blood concentration of fatty acids (stearic acid, oleic acid, arachidonic acid, eicosaepentanoic acid) expressed as percentage (%) [ Time Frame: Before the start of the study (time 0) and after eight weeks (time 2) ]All human blood samples are treated with chloroform: methanol (2:1, v/v), and the samples are centrifuged. The lower layer, containing fatty acids, are removed with care, replaced in a new tube and dried by a centrifugal evaporator. The fatty acid methyl ester (FAME) is obtained by adding toluene and BF3. Samples are collected and transferred into a vial and analyzed by gas chromatography.
- Changes in serum concentration of single subfractions of LDL (expressed as mg/dL) [ Time Frame: Before the start of the study (time 0) and after eight weeks (time 2) ]Small dense LDL analysis: Small dense Lipoproteins (sdLDL) are assayed using Lipoprint LDL System (Quantimetrix, USA). Each serum sample is applied on high resolution polyacrylamide gel tube in order to separate LDL fractions and subfractions by electrophoresis. The resolved lipoproteins bands are scanned and analyzed.
- Changes in the concentrations of radical monocation of 2,2'-azinobis-(3-ethylbenzothiazoline-6-sulfonic acid) (ABTS) expressed as µM Trolox equivalents/g of dry weight [ Time Frame: Before the start of the study (time 0), after four weeks (time 1) and after eight weeks (time 2) ]The ABTS assay will be performed using the commercially available ZENBIO-AOX-1 kit.
- Changes in plasma prothrombotic potential [ Time Frame: Before the start of the study (time 0), after four weeks (time 1) and after eight weeks (time 2) ]The plasma prothrombotic potential will be evaluated using a functional test able to monitor the entire kinetics of thrombin generation, including its inactivation by plasma physiological inhibitors. In these tests, the coagulation will be activated by purified tissue factor.
- Changes in plasma grape miRNA content [ Time Frame: Before the start of the study (time 0) (time 1) and after eight weeks (time 2) ]Total serum RNA, including Small RNAs, will be extracted from plasma (200µL) of the subjects involved in the study using the miRNeasy Mini Kit (QIAGEN). After checking the concentration and quality, the effective presence of miRNAs will be verified by retro-transcription with a specific miRNA kit (TaqMan miRNA Reverse Transcription kit - Life Technologies) using Real Time-polymerase chain reaction (PCR) method.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04053569
|Contact: Maria G Caruso, MD||00390804994 ext firstname.lastname@example.org|
|IRCCS Saverio de Bellis||Not yet recruiting|
|Castellana Grotte, Bari, Italy, 70013|
|Contact: Maria Notarnicola, ScD 00390804994 ext 342 email@example.com|
|Principal Investigator:||Maria Notarnicola, ScD||IRCCS "Saverio de Bellis" Castellana Grotte|