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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02686996
Ethics application status
Date submitted
9/02/2016
Date registered
22/02/2016
Date last updated
22/03/2018

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
Other interventions - 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


Other interventions: 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
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in insulin sensitivity measured by euglycaemic glucose clamp - The clamp will be used to measure insulin sensitivity. The clamp is initiated by an intravenous bolus injection of insulin (9milliUnit/kg). Insulin is then constantly infused at a rate of 40 milliUnit.m-2.min-1 for 120 min into an arm vein, whilst glucose is variably infused to maintain euglycaemia. Plasma glucose values will be monitored every 5 minutes during the clamp and the variable infusion rate of glucose is adjusted to maintain blood glucose at a constant value of 5mmol/L.
Timepoint [1] 0 0
From baseline to 14 weeks
Secondary outcome [1] 0 0
Change in markers of endothelial dysfunction - This is done using non-invasive peripheral arterial tomography (PAT; endothelium-dependent digital pulse amplitude testing (EndoPAT), Itamar Medical Ltd, Israel), which records continuous plethysmo¬graphic signals of the finger arterial pulse wave. Finger plethysmographic probes are placed on each index finger; and after a 5 min equilib¬ration period, a blood pressure cuff on the non-dominant arm is inflated to 60 mmHg above systolic for 5 min and then deflated to induce reactive hyperaemia. Measurements of post-occlusion changes (reactive hyperaemia PAT: RH-PAT) are continued for 10 min. Results are normalised to the non-occluded arm, compensating for potential systemic changes (RH-PAT ratio).
Timepoint [1] 0 0
From baseline to 14 weeks
Secondary outcome [2] 0 0
Change in Acute Insulin Secretory Response - Intravenous Glucose Tolerance Test - This will be measured in response to 25g intravenous glucose and calculated as the average incremental plasma insulin level from the third to the fifth minute after the glucose bolus.
Timepoint [2] 0 0
From baseline to 14 weeks
Secondary outcome [3] 0 0
Change in Resting systolic and diastolic blood pressure - Resting systolic and diastolic blood pressure and pulse rate will be measured using an automated oscillometric measurement system (Dinamap, USA) after a 30 minute rest.
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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
The aim of this study is to determine whether carnosine supplementation in overweight/obese
individuals can improve insulin secretion and/or insulin resistance by decreasing sub
clinical inflammation.

The investigators hypothesise that carnosine supplementation will reduce type 2 diabetes and
cardiovascular risk factors by lowering chronic low-grade inflammation (CLI), oxidative
stress, advanced glycation end products (AGEs), and advanced lipoxidation end products
(ALEs).

Aim :To determine the capacity of carnosine supplementation to decrease major risk factors
for type 2 diabetes and cardiovascular disease and identify metabolic pathways involved,
specifically by:

1. Reducing diabetes risk (insulin sensitivity; secretory function and glucose tolerance)

2. Improving cardiovascular risk factors (lipids; arterial (aortic) stiffness; central
blood pressure (cBP); endothelial function).

3. Decreasing the CLI, oxidative stress, AGEs, and ALEs, and increase detoxification of
reactive carbonyl species (RCSs).
Trial website
https://clinicaltrials.gov/show/NCT02686996
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02686996