This trial is active, not recruiting.

Condition metabolic diseases, type 2 diabetes, cardiovascular disease
Treatment carnosine
Sponsor Jozef Ukropec
Start date December 2013
End date December 2014
Trial size 30 participants
Trial identifier NCT02011100, CarnoDMCVD


Carnosine is a naturally occurring compound with a potential health benefits. In animal studies, carnosine supplementation reduces manifestation of chronic civilization diseases, regulates subclinical inflammation, protein glycation and lipid & glucose metabolism. Our preliminary data showed the relationship between insulin resistance and carnosine content in human skeletal muscle. Based on these unique results we plan to perform intervention study aimed at identifying effects of carnosine on insulin sensitivity and secretion, which might reduce the development of T2D in obese. Similar metabolic effects of vitamin D3 were associated with expression of specific miRNAs. Circulating miRNAs related to carnosine action are unknown. The putative positive effects of carnosine on insulin sensitivity and secretion in obese patients might have a tremendous impact in prevention of type 2 diabetes. Identification of miRNAs associated with carnosine action could provide predictors of successful therapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose basic science
3 months oral carnosine administration in a dose of 2 gram per day, twice a day 1 gram dose (1-0-1)
(Placebo Comparator)
3 months placebo intake - taken twice a day (1-0-1)

Primary Outcomes

oxidative stress
time frame: within one year
chronic systemic inflammation
time frame: one year

Secondary Outcomes

level of glucose intolerance
time frame: within 10 months

Eligibility Criteria

Male or female participants from 25 years up to 50 years old.

Inclusion Criteria: - BMI (28-38 kg.m-2); - waist circumference >94 cm; - % body fat 30% - fasting glycemia < 7 mmol/l Exclusion Criteria: - age < 25 or > 50 years, - change in body weight > 5 kg in last 12 months, - obesity with BMI > 38kg.m-2, - previously or newly (oGTT) diagnosed type 2 diabetes, - allergy, smoking, alcohol abuse, any pharmacotherapy including regular vitamin intake; - cardiovascular, hematologic, respiratory, gastrointestinal, endocrine or oncologic diseases, - kidney disease, acute inflammatory disease.

Additional Information

Official title Randomised Placebo Controlled Study of the Effect of Carnosine Diabetes and Cardiovascular Risk Factors
Principal investigator Jozef Ukropec, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Slovak Academy of Sciences.