Effect of AXA1957 on liver health in adolescents
Research type
Research Study
Full title
A Randomised, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Physiological Effects on Liver Structure and Function of an Amino Acid Food Product, AXA1957, in Adolescent Subjects with Fatty Liver
IRAS ID
264281
Contact name
Saul Faust
Contact email
Sponsor organisation
Perspectum Diagnostics
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
The objective of this study is to understand the safety and tolerability profile of a food additive preparation called AXA1957 and its impact on normal liver structure and function for up to 25 weeks of administration in adolescent participants with fatty liver. The MHRA have confirmed that AXA1957 does not need designation as an investigational medicinal product.
Non-Alcoholic Fatty Liver Disease (NAFLD) is becoming one of the most common forms of liver disease in young people and has been recently reported to be a major health risk factor. Participants (12-17yo) in the UK and USA and will be in the study for 13 or 27 weeks including follow-up visits. Participants will be screened for eligibility for inclusion. During this time adolescents will have their medical history taken, blood tests, physical examination, ECGs, urine test, liver MRI scans, complete a food and activity diary and answer a questionnaire on hunger.
AXA1957 is provided as a dry orange juice powder that is mixed with water every day 30 minutes before 2 main meals (e.g. breakfast and dinner) for the duration of the study. Participants will be randomised once eligible, to one of two groups. One will receive the study food product and the other group will receive a placebo (no active ingredient). Young people will also complete a diary to record when the study food product has been consumed, food & exercise diaries and attend regular clinic visits for assessments (outlined above) whilst enrolled in the study. All relevant information including, providing written instructions on how much of the study food product to take each time, what to do if a drink is missed a drink, clinic visit dates and who to contact with any questions will be provided by the research team.
REC name
London - Queen Square Research Ethics Committee
REC reference
19/LO/0812
Date of REC Opinion
14 Jun 2019
REC opinion
Further Information Favourable Opinion