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Effect of Carnosine on Diabetes and Cardiovascular Risk Factors (Carnorisk)

J

Jozef Ukropec

Status

Completed

Conditions

Metabolic Diseases, Type 2 Diabetes, Cardiovascular Disease

Treatments

Dietary Supplement: Carnosine

Study type

Interventional

Funder types

Other

Identifiers

NCT02011100
CarnoDMCVD

Details and patient eligibility

About

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.

Enrollment

28 patients

Sex

All

Ages

25 to 50 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

28 participants in 2 patient groups, including a placebo group

CARNOSINE
Experimental group
Description:
3 months oral carnosine administration in a dose of 2 gram per day, twice a day 1 gram dose (1-0-1)
Treatment:
Dietary Supplement: Carnosine
placebo
Placebo Comparator group
Description:
3 months placebo intake - taken twice a day (1-0-1)
Treatment:
Dietary Supplement: Carnosine

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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