The Potential of Carnosine Supplementation in Reducing the Cardiometabolic Risk
1 other identifier
interventional
84
1 country
1
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2017
Longer than P75 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
February 9, 2016
CompletedFirst Posted
Study publicly available on registry
February 22, 2016
CompletedStudy Start
First participant enrolled
February 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 12, 2020
CompletedMarch 22, 2018
March 1, 2018
3 years
February 9, 2016
March 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
From baseline to 14 weeks
Secondary Outcomes (3)
Change in markers of endothelial dysfunction
From baseline to 14 weeks
Change in Acute Insulin Secretory Response - Intravenous Glucose Tolerance Test
From baseline to 14 weeks
Change in Resting systolic and diastolic blood pressure
From baseline to 14 weeks
Other Outcomes (10)
Change in Arterial waveform measurement
From baseline to 14 weeks
Change in Oral Glucose Tolerance Test -OGTT
From baseline to 14 weeks
Change in Measure of Adiposity (DEXA)
From baseline to 14 weeks
- +7 more other outcomes
Study Arms (2)
Intervention
ACTIVE COMPARATOREach participant will be given a daily oral dose 2 g of carnosine (2 tablets twice daily) for 14 weeks
Control
PLACEBO COMPARATOREach participant will be given a daily oral dose 2 g of identical placebo tablets ( 2 tablets twice daily) for 14 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Monash Centre for Health Research and Implementation
Melbourne, Victoria, 3168, Australia
Related Publications (1)
Menon K, Cameron JD, de Courten M, de Courten B. Use of carnosine in the prevention of cardiometabolic risk factors in overweight and obese individuals: study protocol for a randomised, double-blind placebo-controlled trial. BMJ Open. 2021 May 13;11(5):e043680. doi: 10.1136/bmjopen-2020-043680.
PMID: 33986049DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbora de courten, MD,PHD,MPH
Monash University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 9, 2016
First Posted
February 22, 2016
Study Start
February 13, 2017
Primary Completion
February 13, 2020
Study Completion
June 12, 2020
Last Updated
March 22, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share