Does supplementation with carnosine improve cardiometabolic health and cognitive function in patients with pre-diabetes and type 2 diabetes? study protocol for a randomised, double-blind, placebo-controlled trial

What Was Tested

This randomized controlled trial paper looks at Carnosine.

At baseline, participants will undergo a medical review and series of tests including anthropometric measurements (body mass index, a dual X-ray absorptiometry and peripheral quantitative computed tomography scan), an oral glucose tolerance test, cardiovascular measurements (central blood pressure, endothelial function and arterial stiffness), cognitive function, physical activity measurement, heart rate variability and liver fibroscan as well as 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.

The findings will be disseminated via peer-reviewed publications and conference presentations.

Who Took Part

PubMed indexes the participants as teenagers, young adults, adults, middle-aged adults and older adults, both men and women.

All baseline measurements will be repeated at the end of the intervention.

How the Study Was Run

In design terms this was a randomized, double-blind, placebo-controlled and parallel-group study.

The participants were allocated by chance, so the Carnosine group and the comparison group should start out alike.

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

Some participants received a placebo instead of Carnosine, giving a reference point.

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

The researchers will employ a parallel design randomised controlled trial.

The change in glycaemic, cardiovascular and cognitive parameters as well as other measures will be compared between the groups.

What Was Measured

PubMed files the paper under topics including Blood Glucose, Cardiovascular Diseases, Carnosine, Cognition, Diabetes Mellitus, Type 2, Dietary Supplements and Glycated Hemoglobin.

Author keywords: general diabetes, lipid disorders and other metabolic, e.g. iron, porphyria.

What This Means in Plain Language

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

The publication is from 2017 (BMJ open), a journal based in England.

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