Effect of Carnosine on Diabetes and Cardiovascular Risk Factors

Study Overview
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Brief Summary
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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.

Official Title
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Randomised Placebo Controlled Study of the Effect of Carnosine Diabetes and Cardiovascular Risk Factors

Conditions
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Metabolic Diseases, Type 2 Diabetes, Cardiovascular Disease

Intervention / Treatment
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* Dietary Supplement: Carnosine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CARNOSINE<br>3 months oral carnosine administration in a dose of 2 gram per day, twice a day 1 gram dose (1-0-1) | Dietary Supplement: Carnosine<br> <br> |
| Placebo Comparator: placebo<br>3 months placebo intake - taken twice a day (1-0-1) | Dietary Supplement: Carnosine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxidative stress | AGEs and lipid peroxidation products | within one year | 
| chronic systemic inflammation | circulating hsCRP | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of glucose intolerance | detected by the oral glucose tolerance test. expressed as 2h glucose, area under the glycemic curve, QUICKI index, HOMA-IR | within 10 months |