The Potential of Carnosine Supplementation in Optimising Cardiometabolic Health

What Was Tested

This registered phase 2 trial tested Carnosine.

It had two arms (groups): Intervention (active comparator) and Control (placebo comparator).

The registry classes the interventions as dietary supplement and drug.

More on the Plan

Type 2 diabetes is a major public health problem worldwide.

In Australia, direct healthcare costs for DM2 are currently estimated as $1.1 billion annually, with the prospect of doubling by 2025.

The annual healthcare costs for CVD in Australia now amount to $7.7 billion; and the total aggregated costs, including loss of income, are much higher again.

Treating DM2 and CVD is expensive and often unsatisfactory.

Who Took Part

40 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Age \>=18 or \<=70 years. Weight change \< 5 kg in last 6 months. Patients with prediabetes (Impaired glucose tolerance and impaired fasting glycaemia) or type 2 diabetes (diet controlled or on oral therapy). Patients will have to be on oral therapy for diabetes (without changes in treatment) at least for 3 months. No recent blood transfusion (3 months).

The full record lists 10 inclusion and 10 exclusion criteria; among the exclusions: age \<18 or \> 70 years; weight change \> 5 kg in last 6 months; morbid obesity (body mass index \>40 kg/m2).

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.

As a double-blind Carnosine study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2016-10 with completion listed for 2023-01.

It ran at 1 site in Australia.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Oral Glucose Tolerance Test (time frame: baseline and 14 weeks).

It also tracked 13 secondary outcomes, for example Change in HbA1c, Change in lipid profile, Change in systolic and diastolic blood pressure, Change in arterial stiffness and central blood pressure, Change in markers of endothelial dysfunction and Change in heart rate variability.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Carnosine in 40 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.