Effect of a Multi-ingredient on Visceral Adiposity and Non-alcoholic Fatty Liver Disease in Individuals With Abdominal Obesity

What Was Tested

In this not phased trial, researchers set out to test Carnosine for fatty liver & elevated liver enzymes.

It had two arms (groups): Multi-ingredient of L-histidine, L-serine, L-carnosine and N-Acetylcysteine (experimental) and Placebo (placebo comparator).

Participants will daily consume the multi-ingredient (L-Histidine, L-Serine, L-Carnosine and N-Acetylcysteine) for 12 weeks.

Participants will daily consume the placebo (maltodextrin) for 12 weeks.

The registry classes the interventions as dietary supplement.

More on the Plan

World Health Organization (WHO) defines obesity as an excess of fat accumulation in adipose tissues and in other metabolic organs, leading to serious health implications.

Current therapies against obesity are mainly focused on weight loss, including lifestyle intervention, to modify eating behaviours and to promote physical activity.

However, the compliance of patients with these therapies is small.

In addition, there are some drugs to fight against these diseases.

Who Took Part

20 actual participants took part.

It was open to men only aged from 40 years with no upper age limit.

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

Examples of who could join: Men older than 40 years. BMI ≥30.0 kg/m\^2 and ≤35.0 kg/m\^2. Waist circumference ≥102 cm. Read, write and speak Catalan or Spanish. Sign the informed consent.

The full record lists 5 inclusion and 17 exclusion criteria; among the exclusions: present values of body mass index \> 35 kg/m\^2; present values of waist circumference \> 150 cm; present diabetes.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The fatty liver & elevated liver enzymes participants were allocated by chance, so the Carnosine group and the comparison group should start out alike.

The Carnosine group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the fatty liver & elevated liver enzymes participants and researchers unaware of who received Carnosine.

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

It started in 2023-05-01 with completion listed for 2023-12-20.

It ran at 1 site in Spain.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Visceral Adiposity (time frame: Change from Baseline Visceral Adiposity at 12 weeks for each of the two treatments (multi-ingredient and placebo)).

It also tracked 44 secondary outcomes, for example Change in Hepatic Steatosis, Height (cm), Change in Weight (kg), Change in Body Mass Index (BMI) (Kg/m^2), Change in Neck circumference (cm) and Change in Arm circumference (cm).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Carnosine in 20 people with fatty liver & elevated liver enzymes.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Carnosine compound page, Fatty liver & elevated liver enzymes research.