Clinical Study of Hydroxytyrosol (HT) in Mitochondrial Diseases

Summary

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.

Conditions

• Mitochondrial Diseases

Interventions

DIETARY_SUPPLEMENT

hydroxytyrosol (HT) intake

MD patients will receive hydroxytyrosol (HT) daily as dietary supplements for 12 months. After that, patients will be randomly assigned in 1:1 ratio to continue on receiving hydroxytyrosol (HT) as their dietary supplements for another 6 months.

DIETARY_SUPPLEMENT

hydroxytyrosol (HT) intake and withdraw

MD patients will receive hydroxytyrosol (HT) daily as dietary supplements for 12 months. After that, patients will be randomly assigned in 1:1 ratio to withdraw from receiving hydroxytyrosol (HT) as their dietary supplements for another 6 months.

Sponsors & Collaborators

• The University of Hong Kong

  collaborator OTHER

• Hong Kong Children's Hospital

  lead OTHER

Principal Investigators

• Cheuk Wing Fung · Hong Kong Children's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-07-05

Primary Completion

2024-07-31

Completion

2024-07-31

Countries

• Hong Kong

Study Locations