NCT04061070

Effects of Trehalose and Polyphenols in Vasculopathic Patients

Completed NA Last updated 18 June 2023

What this trial tests

NA trial testing Supplementation with mix of threalose plus polyphenols in Oxidative Stress in 80 participants. Completed in 30 April 2021.

Timeline

12 December 2019

Primary endpoint
30 September 2020

30 April 2021

Quick facts

Lead sponsor	University of Roma La Sapienza
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	80
Start date	12 December 2019
Primary completion	30 September 2020
Estimated completion	30 April 2021
Sites	2 locations across Italy

Drugs / interventions tested

• Supplementation with mix of threalose plus polyphenols
• No Supplementation with mix of threalose plus polyphenols

Conditions studied

• Oxidative Stress — all drugs for Oxidative Stress →
• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →

Sponsor

University of Roma La Sapienza

Who can join

Adults 60 to 80, any sex, with Oxidative Stress or Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. The role of autophagy in cardiovascular pathology.
   Gatica D, Chiong M, Lavandero S, Klionsky DJ. · · 2022 · cited 72× · PMID 33956077 · DOI 10.1093/cvr/cvab158
2. Mitochondrial Oxidative Stress and Cell Death in Podocytopathies.
   Zhu YT, Wan C, Lin JH, Hammes HP, et al · · 2022 · cited 31× · PMID 35327595 · DOI 10.3390/biom12030403
3. Dietary Polyphenols against Oxidative Stress in Head and Neck Cancer: What's New, What's Next.
   Ballini A, Zhurakivska K, Troiano G, Lo Muzio L, et al · · 2024 · cited 7× · PMID 38169656 · DOI 10.7150/jca.90545
4. Lysosomal Stress in Cardiovascular Diseases: Therapeutic Potential of Cardiovascular Drugs and Future Directions.
   Otoda T, Aihara KI, Takayama T. · · 2025 · cited 6× · PMID 40426881 · DOI 10.3390/biomedicines13051053
5. Natural Activators of Autophagy Increase Maximal Walking Distance and Reduce Oxidative Stress in Patients with Peripheral Artery Disease: A Pilot Study.
   Martinelli O, Peruzzi M, Bartimoccia S, D'Amico A, et al · · 2022 · cited 4× · PMID 36139910 · DOI 10.3390/antiox11091836