Research on Prevention, Intervention and Mechanisms of Obesity and Its Comorbidities

What Was Tested

The trial (not phased) is built around Carnosine.

It had four arms (groups): Complex Intervention with Carnosine (experimental), Complex Intervention with placebo (experimental), Without complex intervention with carnosine (experimental) and Without complex intervention with placebo (no intervention).

Obese middle aged individuals will be subjected to 3 month complex lifestyle intervention including exercise (3 times per week) nutritional (weekly consultation) and psychological (monthly) interventions combined with oral administration of identically looking placebo.

The registry classes the interventions as behavioral and dietary supplement.

More on the Plan

Starting with warm-up and stretching cool down at the end.

The individualized training program will be based on the actual patients physical fitness (VO2max, bicycle spiroergometry) and muscle strength (dynamometry).

The training will take place in small groups of 4-5 volunteers.

There will be 15-minute breaks for ventilation and surface disinfection between training sessions.

Who Took Part

The registry lists 60 planned participants were the target.

It was open to people of any sex aged from 25 years up to 45 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Sedentary men and women (approximately 1:1) aged 25-45 years, BMI 28-38 kg/m2. Capable to complete a training intervention (assessment by a cardiologist). Signed informed consent. Absence of any psychological, sociological or geographical factors that could jeopardize participation in the study.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: any chronic disease (oncological, cardiovascular, neurological, liver, kidney or other diseases and its acute complications at the discretion of the doctor);; no cooperation of probands;; smoking, alcohol or drugs abuse;.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Because people in this Carnosine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Blinding on both sides kept the participants and researchers unaware of who received Carnosine.

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

It started in 2021-11-01 with completion listed for 2023-06-30.

It ran at 1 site in Slovakia.

Its stated primary purpose is supportive care.

What Was Measured

Researchers chose this as the main measure: Intervention induced change in abdominal adiposity (time frame: 3 months). Intervention induced change in VO2max (time frame: 3 months). Intervention induced change in abdominal muscle mass (time frame: 3 months).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Carnosine in 60 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Carnosine compound page, all human trials.