Effect of Multi-ingredient on Visceral Adiposity & Non-alcoholic Fatty Liver Disease in Postmenopausal Women 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

Menopause leads to a decline in estrogen levels, affecting lipid metabolism and promoting abdominal and visceral fat accumulation.

While the prevalence of NAFLD is initially higher in men, it becomes comparable or even higher in postmenopausal women due to these metabolic changes.

However, the use of HRT must be carefully evaluated due to potential adverse effects on cardiovascular health.

A randomized, parallel, placebo-controlled, single-center, triple-blind clinical trial with a 1:1:1 ratio between interventions with 50 participants will be conducted.

Who Took Part

50 actual participants took part.

It was open to women only aged from 50 years up to 65 years.

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

Examples of who could join: Postmenopausal women aged 50 to 65 years. BMI ≥27.5 kg/m\^2 and ≤32.5 kg/m\^2. Waist circumference ≥88 cm. No hormone replacement therapy. Read, write and speak Catalan or Spanish.

The full record lists 6 inclusion and 17 exclusion criteria; among the exclusions: present values of body mass index \< 27.5 kg/m\^2 or \> 32.5 kg/m\^2; present values of waist circumference \> 115 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.

Neither the fatty liver & elevated liver enzymes participants nor the staff measuring them knew who was on Carnosine, so expectations could not easily colour the readings.

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

It started in 2024-06-07 with completion listed for 2025-04-08.

It ran at 2 sites in Spain (2).

Its stated primary purpose is treatment.

What Was 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 53 secondary outcomes, for example Height (cm), Age, Ethnicity, Change in Body Weight (kg), Change in Body Mass Index (BMI) (Kg/m^2) and Change in Neck circumference (cm).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Carnosine in 50 people with fatty liver & elevated liver enzymes.

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.