Effects of Trehalose and Polyphenols in Vasculopathic Patients

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.

Conditions

• Oxidative Stress
• Cardiovascular Diseases

Interventions

OTHER

Supplementation with mix of threalose plus polyphenols

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

OTHER

No Supplementation with mix of threalose plus polyphenols

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

Sponsors & Collaborators

• Peruzzi Mariangela

  collaborator UNKNOWN

• University of Roma La Sapienza

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-12-12

Primary Completion

2020-09-30

Completion

2021-04-30

Countries

• Italy

Study Locations