Trimethylamine N-oxide Effects of a Pomegranate Supplement Simultaneously With Carnitine (TESSA)

What Was Tested

This registered not phased trial tested L-Carnitine.

Trimethylamine N-oxide (TMAO) is produced in some individuals whose diets include meat, fish, and dairy.These foods are rich in L-carnitine.

L-carnitine is metabolised by the liver and gut microorganisms (bacteria) into TMAO.

In the TESSA study, investigators will explore whether pomegranate extract can lower the production of TMAO in healthy men and women.

It had two arms (groups): Pomegranate extract (experimental) and Microcrystalline cellulose (placebo comparator).

The registry classes the interventions as dietary supplement.

More on the Plan

Investigators are seeking men and women over the age of 18 years who habitually consume meat, fish, and/or eggs and are TMAO producers to determine whether pomegranate extract affects L-carnitine metabolism compared to a matched placebo.

This study is conducted in two phases.

The first phase involves two study visits where investigators will identify and invite TMAO producing individuals to continue to the second phase of this study.

Moreover, investigators will ask the participant to complete a food frequency questionnaire.

Who Took Part

The registry lists 39 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Individuals who regularly eat meat (4 portions of meat per week for at least 2 months prior to enrolment in the study). Aged 18 and older. Body Mass Index (BMI) between 18.5 - 30 kg/m2. Meets first phase inclusion criteria.

The full record lists 6 inclusion and 23 exclusion criteria; among the exclusions: consume an entirely vegan, vegetarian, or pescatarian diet within the last two months; do not have access to a freezer to store some provided meals and ice packs; have a known allergy to the tablets, capsules (i.e., pomegranate), or standardised meals such as wheat, eggs, milk, nuts, and soybeans.

How the Study Was Run

It was run as a randomized, crossover and triple-blind study.

Random assignment meant chance, not the researchers, decided who got L-Carnitine and who got the comparison, which limits bias.

Each person switched between L-Carnitine and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received L-Carnitine.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2024-08-12 with completion listed for 2027-05-31.

It ran at 1 site in United Kingdom.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Difference in the area under the curve (AUC) of blood plasma TMAO concentrations after pomegranate extract and microcrystalline cellulose interventions (time frame: Day 2,3,4,16,17,and 18).

It also tracked 11 secondary outcomes, for example Changes in area under the curve (AUC) from plasma concentrations of L-carnitine and its metabolites, Change in peak plasma concentration (Cmax) of L-carnitine and its metabolites, Change in the time to reach peak plasma concentration (Tmax) of L-carnitine and its metabolites, Change in plasma half-life (t1/2) of L-carnitine and its metabolites, Change in the area under the curve (AUC) from urine concentrations of L-carnitine and its metabolites and Change in pomegranate polyphenols and their metabolite concentrations from pooled 24 hour urine collections.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of L-Carnitine in 39 people.

Its size is small, so on its own it can only give an early look.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.