TESSA study (Version 1)
Research type
Research Study
Full title
The trimethylamine N-oxide (TMAO)-reducing effects of a pomegranate supplement simultaneously administered with L-carnitine
IRAS ID
336410
Contact name
Paul A Kroon
Contact email
Sponsor organisation
Quadram Institute Bioscience
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
We propose a two-phased intervention trial to estimate the effect of a pomegranate extract (PE) on trimethylamine N-oxide (TMAO) production in omnivore participants. TMAO is produced in some individuals whose diets include foods high in L-carnitine, such as meat, fish, and dairy. L-carnitine is metabolised by gut microbiota to trimethylamine (TMA), which is converted to TMAO in the body. High levels of TMAO are linked with adverse cardiovascular events, such as heart failure, atherosclerosis, hypertension, arrhythmia, and coronary artery disease. Currently, no effective, low-risk treatments are available to reduce TMA and TMAO levels. We discovered that PE reduces TMA production from L-carnitine in our lab-based models. Following these observations, we propose this study to investigate the effects of PE on TMAO production from an oral carnitine response test (OCRT) in healthy adults. During the OCRT participants will consume 1.5 g L-carnitine.\n\nWe aim to recruit 40 participants onto the TMAO Status Phase (Phase I), during which participants undergo an OCRT to assess their TMAO response status. Those who are deemed high TMAO producers and who also meet the eligibility criteria will be invited to the Intervention Phase (Phase II). We aim to have 16 participants complete Phase II. Phase I will start prior to phase II and will run in parallel until 16 participants have completed Phase II. Phase II is an 18-day double-blind, randomised, placebo-controlled, crossover study and will consist of two 48-hour pharmacokinetic studies involving an OCRT, during which participants consume 1.5 g L-carnitine along with the pomegranate extract or the placebo control. During this period, timed blood, urine, and faecal samples will be collected. Participants will be asked to follow a restricted diet and consume standardised meals.\n
REC name
South East Scotland REC 01
REC reference
24/SS/0047
Date of REC Opinion
24 Jun 2024
REC opinion
Further Information Favourable Opinion