Effect of Carnosine on Diabetes and Cardiovascular Risk Factors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2018-03-31

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.

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Detailed Description

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Conditions

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Metabolic Diseases, Type 2 Diabetes, Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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CARNOSINE

3 months oral carnosine administration in a dose of 2 gram per day, twice a day 1 gram dose (1-0-1)

Group Type EXPERIMENTAL

Carnosine

Intervention Type DIETARY_SUPPLEMENT

placebo

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

Group Type PLACEBO_COMPARATOR

Carnosine

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Carnosine

Intervention Type DIETARY_SUPPLEMENT

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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No