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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02686996




Registration number
NCT02686996
Ethics application status
Date submitted
9/02/2016
Date registered
22/02/2016

Titles & IDs
Public title
The Potential of Carnosine Supplementation in Reducing the Cardiometabolic Risk
Scientific title
The Potential of Carnosine Supplementation in Reducing the Cardiometabolic Risk: a Double-blind, Placebo-controlled Trial
Secondary ID [1] 0 0
16061A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insulin Sensitivity 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - carnosine
Other interventions - Placebo

Active comparator: Intervention - Each participant will be given a daily oral dose 2 g of carnosine (2 tablets twice daily) for 14 weeks

Placebo comparator: Control - Each participant will be given a daily oral dose 2 g of identical placebo tablets ( 2 tablets twice daily) for 14 weeks


Treatment: Other: carnosine
Carnosine capsules (2g) twice per day for 14 weeks

Other interventions: Placebo
Placebo (methylcellulose) capsules for control group identical to intervention capsules and dose
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in insulin sensitivity measured by euglycaemic glucose clamp
Timepoint [1] 0 0
From baseline to 14 weeks
Secondary outcome [1] 0 0
Change in markers of endothelial dysfunction
Timepoint [1] 0 0
From baseline to 14 weeks
Secondary outcome [2] 0 0
Change in Acute Insulin Secretory Response - Intravenous Glucose Tolerance Test
Timepoint [2] 0 0
From baseline to 14 weeks
Secondary outcome [3] 0 0
Change in Resting systolic and diastolic blood pressure
Timepoint [3] 0 0
From baseline to 14 weeks

Eligibility
Key inclusion criteria
* Age >18 or <60 years,
* Weight change < 5 kg in last 12 months
* BMI >25kg/m2 but weight <159kg due to DEXA scan restrictions
* Non-diabetic, no allergy, non-smoker, no high alcohol use
* No current intake of medications including vitamin supplements
* No kidney, cardiovascular, haematological, respiratory, gastrointestinal, endocrine or central nervous system disease, as well as no psychiatric disorders, no active cancer within the last five years; no presence of acute inflammation (by history, physical or laboratory examination)
* Not pregnant or lactating
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Age <18 or > 60 years
* Weight change > 5 kg in last 12 months
* Diabetes (diagnosed or oral glucose tolerance test (OGTT), allergy
* Current smoking habit, high alcohol use
* Current intake of medications including vitamin supplements
* Kidney, cardiovascular, haematological, respiratory, gastrointestinal, endocrine or central nervous system disease, as well as psychiatric disorder, active cancer within the last five years; presence of acute inflammation (by history, physical or laboratory examination)
* pregnancy or lactation

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/02/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
12/06/2020
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Centre for Health Research and Implementation - Melbourne
Recruitment postcode(s) [1] 0 0
3168 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Barbora de courten, MD,PHD,MPH
Address 0 0
Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Barbora de Courten, MD,PHD,MPH
Address 0 0
Country 0 0
Phone 0 0
+61 385722651
Fax 0 0
Email 0 0
barbora.decourten@monash.edu
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02686996