NCT04543968

Clinical Study of Hydroxytyrosol (HT) in Mitochondrial Diseases

Completed NA Last updated 6 November 2024

What this trial tests

NA trial testing hydroxytyrosol (HT) intake in Mitochondrial Diseases in 10 participants. Completed in 31 July 2024.

Timeline

5 July 2022

Primary endpoint
31 July 2024

31 July 2024

Quick facts

Lead sponsor	Hong Kong Children's Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	5 July 2022
Primary completion	31 July 2024
Estimated completion	31 July 2024
Sites	1 location across Hong Kong

Drugs / interventions tested

• hydroxytyrosol (HT) intake
• hydroxytyrosol (HT) intake and withdraw

Conditions studied

• Mitochondrial Diseases — all drugs for Mitochondrial Diseases →

Sponsor

Hong Kong Children's Hospital

Who can join

Adults 3 to 18, any sex, with Mitochondrial Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Mitochondrial diseases (MDs) are the commonest group of inborn errors resulting from primary dysfunction of mitochondrial respiratory chain (MRC). High phenolics-containing extra-virgin olive oil (EVOO) can be one of the potential dietary supplements for the treatment of MD. Previous reports demonstrated that phenolics including oleuropein, oleocanthal, hydroxytyrosol and tyrosol found in EVOO have strong antioxidant properties against the oxidative stress in brain tissue and showed a protective effect on mitochondria by restoring mitochondrial enzymatic activities.

This proposed study is an open-label pilot/ feasibility clinical trial using hydroxytyrosol (HT) as dietary supplements in a cohort of 12 MD patients recruited from the Hong Kong Children's Hospital (HKCH).

The objective is to explore the longitudinal effect of receiving hydroxytyrosol (HT) as dietary supplements over a 12-month period and the change on a 6-month period after withdrawal. The applicability of the outcome measures will be evaluated in the current trial for future clinical studies and obtain relevant data for the next phase of the clinical trial on hydroxytyrosol (HT) efficacy. Besides, the tolerability of hydroxytyrosol (HT) in MD patients will be evaluated.

The primary outcome measure is the functional assessment of the patient's clinical outcomes by International Paediatric Mitochondrial Disease Score (IPMDS). Secondary outcome measures included the measurement of biochemical and radiological parameters. Besides, tolerability and quality of life of the subjects will be determined.

Relevant data including the feasibility of subject recruitment, withdrawal rate, feasibility of data collection of outcome measures, longitudinal effect of hydroxytyrosol (HT) on the outcome measures in the trial can be collected and analysed in this pilot study providing important information for the future clinical trials. The ultimate goal is to develop effective therapies to lower mortality, improve the clinical outcomes and quality of life in MD patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Polyphenols, the Healthy Brand of Olive Oil: Insights and Perspectives.
   Finicelli M, Squillaro T, Galderisi U, Peluso G. · · 2021 · cited 36× · PMID 34836087 · DOI 10.3390/nu13113831