CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 80 enrolled
Drug / intervention
Supplementation with mix of threalose plus polyphenols +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04061070
NCT04061070N/ACompleted

Effects of Trehalose and a Mix of Polyphenols on Endothelial Function, Oxidative Stress, Platelet Function and Autophagy in Vasculopathic Patients

University of Roma La Sapienza·interventional·Posted Aug 19, 2019·Updated Jun 18, 2023

In Brief

A clinical study evaluating Supplementation with mix of threalose plus polyphenols and No Supplementation with mix of threalose plus polyphenols for Oxidative Stress and Cardiovascular Diseases. Completed, enrolled 80 participants across 2 sites.

Detailed Summary

Peripheral arterial disease (PAD) is an important manifestation of systemic atherosclerosis and is characterized by obstruction of the arteries of the lower extremities. PAD is usually associated with vascular complications that occur not only in peripheral circulation but also in cerebral and coronary trees (PubMed ID: 9892517). Endothelial dysfunction, reduced glucose oxidation, accumulation of toxic metabolites, alteration in nitric oxide (NO) generation and oxidative stress seem to play a role among the factors that contribute to reducing blood flow in PAD patients (PubMed ID: 17298965). Hypertension is a risk factor for vascular disorders, including PAD. In fact, it has been shown that 55% of PAD patients are hypertensive. (PubMed ID: 15579058) PAD and hypertension patients have a risk of cardiovascular and cerebrovascular mortality increased two to three times compared to healthy subjects. The alteration of platelet function is implicated in the development and progression of atherosclerosis, as well as in the pathogenesis of acute cardiac ischemic events. Platelet activation is increased in patients with PAD and hypertension compared to healthy controls, suggesting a pro-thrombotic state. Polyphenols are a class of natural, synthetic and semisynthetic substances with beneficial effects on human health. In particular, the polyphenols exert their beneficial effect through 1) the inhibition of NADPH oxidase (Nox2), which is crucial for the formation of reactive oxygen species (ROS); 2) an antiplatelet effects 3) the activation of autophagy. Trehalose is a natural disaccharide that performs multiple functions such as a protective action against oxidative stress, temperature changes, accumulation of protein aggregates and dehydration. Furthermore, recent evidence has shown that trehalose could prevent inflammatory responses induced by endotoxic shock both in vivo and in vitro. Therefore the purpose of this work will be to determine in PAD and hypertension patients the effect of the intake of trehalose and a polyphenol mix on oxidative stress biomarkers, autophagic activity and endothelial dysfunction.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
CollaboratorsPeruzzi Mariangela

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedAug 19, 2019
Enrollment StartDec 12, 2019
Primary CompletionSep 30, 2020
Study CompletionApr 30, 2021
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 6.9 years ago

Interventions

Supplementation with mix of threalose plus polyphenolsother

The patients will be treated with a mix of trehalose plus polyphenols for 60 days

No Supplementation with mix of threalose plus polyphenolsother

The patients will not be treated with a mix trehalose plus polyphenols for 60 days