NCT02011100

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 13, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

4 years

First QC Date

December 5, 2013

Last Update Submit

April 14, 2018

Conditions

Metabolic Diseases, Type 2 Diabetes, Cardiovascular Disease

Outcome Measures

Primary Outcomes (2)

  • oxidative stress

    AGEs and lipid peroxidation products

    within one year

  • chronic systemic inflammation

    circulating hsCRP

    one year

Secondary Outcomes (1)

  • level of glucose intolerance

    within 10 months

Other Outcomes (1)

  • muscle carnosine content

    within 9 months

Study Arms (2)

CARNOSINE

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Carnosine

Interventions

CarnosineDIETARY_SUPPLEMENT
CARNOSINEplacebo

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • BMI (28-38 kg.m-2);
  • waist circumference \>94 cm;
  • % body fat 30%
  • fasting glycemia \< 7 mmol/l

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Univeristy Hospital in Bratislava

Bratislava, 81369, Slovakia

Location

Institute of Experimental Endocrinology Slovak Academy of Sciences

Bratislava, 83306, Slovakia

Location

MeSH Terms

Conditions

Metabolic DiseasesDiabetes Mellitus, Type 2Cardiovascular Diseases

Interventions

Carnosine

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesDiabetes MellitusGlucose Metabolism DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsDipeptidesOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Jozef Ukropec, PhD

    Institute of experimental endocrinology SAS

    PRINCIPAL INVESTIGATOR

  • Barbara Ukropcova, MD, PhD

    Faculty of Medicine Comenius University & Institute of Experimental Endocrinology SAS

    STUDY DIRECTOR

  • Boris Krahulec, MD, PhD

    University Hospital in Bratislava

    STUDY CHAIR

  • Barbora deCourten, MD, MPH, PhD, FRACP

    Monash University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 5, 2013

First Posted

December 13, 2013

Study Start

December 1, 2013

Primary Completion

December 1, 2017

Study Completion

March 1, 2018

Last Updated

April 17, 2018

Record last verified: 2018-04

Locations

SL(2)