Use of carnosine in the prevention of cardiometabolic risk factors in overweight and obese individuals: study protocol for a randomised, double-blind placebo-controlled trial

What Was Tested

Researchers studied Carnosine in this clinical study publication.

At baseline, participants will have anthropometric measurements (BMI, dual X-ray absorptiometry and peripheral quantitative CT scan), measurements of glucose metabolism (oral glucose tolerance test, intravenous glucose tolerance test and euglycaemic hyperinsulinaemic clamp), cardiovascular measurements (central blood pressure, endothelial function and arterial stiffness), a muscle and fat biopsy, physical activity measurement, liver fibroscan, cognitive function and questionnaires to assess dietary habits, sleep quality, depression, and quality of life.

Why It Was Studied

This study is approved by the Human Research Ethics Committee of Monash Health and Monash University, Australia.

Who Took Part

Fifty participants will be recruited to be enrolled in a double-blind randomised controlled trial.

Eligible participants with a body mass index (BMI) between 25 and 40 kg/m2 will be randomly assigned to the intervention or placebo group.

How the Study Was Run

The researchers set it up as a randomized, double-blind and placebo-controlled study.

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

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

The comparison arm used a placebo, so changes seen with Carnosine could be set against what happens without it.

Following a medical review and oral glucose tolerance test to check eligibility, participants will then undergo testing.

In the 15th week, all assessments will be repeated.

The preplanned outcome metric is the change between baseline and follow-up measures.

What Was Measured

The subject headings attached to it are Australia, Cardiometabolic Risk Factors, Carnosine, Obesity, Overweight, Quality of Life and Randomized Controlled Trials as Topic.

The authors tagged it with the keywords cardiology, general diabetes and public health.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Carnosine.

The publication is from 2021 (BMJ open), a journal based in England.

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