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Effect of Carnosine on Diabetes and Cardiovascular Risk Factors

Plain-language guide to NCT02011100: not phased randomized trial of Carnosine, 28 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT02011100
Phase
not phased
Status
completed
Start
2013-12
Completion (planned or actual)
2017-12
Participants
28 (actual)
Design
randomized, triple-blind, basic_science
Conditions studied
Metabolic Diseases, Type 2 Diabetes, Cardiovascular Disease
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Carnosine.

It had two arms (groups): CARNOSINE (experimental) and placebo (placebo comparator).

3 months placebo intake - taken twice a day (1-0-1).

The registry classes the interventions as dietary supplement.

Who Took Part

28 actual participants took part.

It was open to people of any sex aged from 25 years up to 50 years.

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

Examples of who could join: BMI (28-38 kg.m-2);. Waist circumference \>94 cm;.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: age \< 25 or \> 50 years,; change in body weight \> 5 kg in last 12 months,; obesity with bmi \> 38kg.m-2,.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

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

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 and investigator.

It started in 2013-12 with completion listed for 2017-12.

It ran at 2 sites in Slovakia (2).

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): oxidative stress (time frame: within one year). chronic systemic inflammation (time frame: one year).

It also tracked 1 secondary outcome, for example level of glucose intolerance.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Carnosine in 28 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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

Our Notes on the Compound

Carnosine: A dipeptide of beta-alanine and histidine found in muscle and brain; studied as a supplement in human trials.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.