Grape Polyphenols and Metabolic Syndrome

NCT04053569 | Unknown

• 1 other identifier: RC2019019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Fruits and vegetables are beneficial for patients with metabolic syndrome, a condition characterized by the coexistence of various risk factors (obesity, hypertension, hypercholesterolemia, insulin resistance) that predispose to cardiovascular disease and diabetes. Diets such as the Mediterranean diet, rich in flavonoids and polyphenolic compounds can exert a high anti-inflammatory, antithrombotic and antiproliferative action. Several studies have shown that grape polyphenols exert a crucial protective action against the onset of cardiovascular, neurodegenerative, and cancer diseases. On the other hand, little information is available on the health effects deriving from the consumption of table grapes on cell membranes lipidomic profile. On this basis, the aim of this study is the evaluation of possible changes in lipidomic profile and plasma antioxidant activity induced by a diet enriched with table grape polyphenols.

Conditions

Metabolic Syndrome, Protection Against

Keywords

polyphenols; diet; lipidomics; metabolic syndrome

Outcome Measures

Primary Outcomes (3)

• Changes in serum concentrations (mg/dL) of cholesterol, triglycerides, glucose

  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).

  Before the start of the study (time 0), after four weeks (time 1) and after eight weeks (time 2)

• Changes in blood concentration of fatty acids (stearic acid, oleic acid, arachidonic acid, eicosaepentanoic acid) expressed as percentage (%)

  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.

  Before the start of the study (time 0) and after eight weeks (time 2)

• Changes in serum concentration of single subfractions of LDL (expressed as mg/dL)

  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.

  Before the start of the study (time 0) and after eight weeks (time 2)

Secondary Outcomes (3)

• 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

  Before the start of the study (time 0), after four weeks (time 1) and after eight weeks (time 2)

• Changes in plasma prothrombotic potential

  Before the start of the study (time 0), after four weeks (time 1) and after eight weeks (time 2)

• Changes in plasma grape miRNA content

  Before the start of the study (time 0) (time 1) and after eight weeks (time 2)

Study Arms (2)

Diet with table grape

EXPERIMENTAL

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

Specific dietary advice

NO INTERVENTION

Dietary recommendations (such as limitation of alcohol, caffeine), and low consumption of fruits.

Interventions

Table Grape supplement DIETARY_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.

Diet with table grape

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> 30 years and \<65 years
• overweight.

You may not qualify if:

• cardiovascular disease.
• stroke
• treatment with insulin or oral hypoglycemic drugs
• fasting glucose \> 126 mg / dl, or casual glycemia \> 200 mg / dl
• more than 20 g/day of alcohol intake
• serious medical conditions that may compromise participation in the trial
• subjects following a special diet or involved in a weight-loss program or unable to follow a diet for religious or other reasons.

Sponsors & Collaborators

• Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis: lead

Study Sites (1)

IRCCS Saverio de Bellis

Castellana Grotte, Bari, 70013, Italy

Location

Related Publications (5)

• Li B, Zhang C, Zhan YT. Nonalcoholic Fatty Liver Disease Cirrhosis: A Review of Its Epidemiology, Risk Factors, Clinical Presentation, Diagnosis, Management, and Prognosis. Can J Gastroenterol Hepatol. 2018 Jul 2;2018:2784537. doi: 10.1155/2018/2784537. eCollection 2018.

  PMID: 30065915 BACKGROUND

• Liu YC, Chen WL, Kung WH, Huang HD. Plant miRNAs found in human circulating system provide evidences of cross kingdom RNAi. BMC Genomics. 2017 Mar 14;18(Suppl 2):112. doi: 10.1186/s12864-017-3502-3.

  PMID: 28361700 BACKGROUND

• Mlotshwa S, Pruss GJ, MacArthur JL, Endres MW, Davis C, Hofseth LJ, Pena MM, Vance V. A novel chemopreventive strategy based on therapeutic microRNAs produced in plants. Cell Res. 2015 Apr;25(4):521-4. doi: 10.1038/cr.2015.25. Epub 2015 Feb 27. No abstract available.

  PMID: 25721325 BACKGROUND

• Notarnicola M, Caruso MG, Tutino V, Bonfiglio C, Cozzolongo R, Giannuzzi V, De Nunzio V, De Leonardis G, Abbrescia DI, Franco I, Intini V, Mirizzi A, Osella AR. Significant decrease of saturation index in erythrocytes membrane from subjects with non-alcoholic fatty liver disease (NAFLD). Lipids Health Dis. 2017 Aug 23;16(1):160. doi: 10.1186/s12944-017-0552-0.

  PMID: 28830448 BACKGROUND

• Ammollo CT, Semeraro F, Milella RA, Antonacci D, Semeraro N, Colucci M. Grape intake reduces thrombin generation and enhances plasma fibrinolysis. Potential role of circulating procoagulant microparticles. J Nutr Biochem. 2017 Dec;50:66-73. doi: 10.1016/j.jnutbio.2017.08.012. Epub 2017 Sep 1.

  PMID: 29040837 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Maria Notarnicola, ScD

  IRCCS "Saverio de Bellis" Castellana Grotte

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (participant)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Nutritional Pathophysiology Laboratory - IRCCS S. de Bellis

Model Details: Randomized, single-blind clinical trial

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 12, 2019
• Study Start: October 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2022
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)