Metabolic Diseases, Type 2 Diabetes, Cardiovascular Disease
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTCarnosine
Sponsors
Jozef Ukropec
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| oxidative stress | within one year | AGEs and lipid peroxidation products |
| chronic systemic inflammation | one year | circulating hsCRP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| level of glucose intolerance | within 10 months | detected by the oral glucose tolerance test. expressed as 2h glucose, area under the glycemic curve, QUICKI index, HOMA-IR |
Other
| Measure | Time frame | Description |
|---|---|---|
| muscle carnosine content | within 9 months | assessed by 1H-MRS of muscle in vivo (7T Magnet, Siemens, Germany) it will be expressed relative to creatine signal. |
Countries
Slovakia
Outcome results
None listed