Poor Glycemic ControlPhase 2NCT02917928
The Potential of Carnosine Supplementation in Optimising Cardiometabolic Health
A Phase 2 study testing carnosine in people with Poor Glycemic Control and Cardiovascular Risk Factors, run by Monash University at 1 site in Australia.
Trial summary
The investigators hypothesise that carnosine supplementation will improve: 1. glycaemic control 2. cardiovascular risk factors 3. cognitive outcomes in patients with prediabetes and type 2 diabetes, and this will be modulated by reduction in chronic low grade inflammation, oxidative stress and circulating advanced… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Poor Glycemic Control, Cardiovascular Risk Factors, Cognitive Function 1, Social
- What is being tested?
- carnosine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2016to Jul 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >=18 or <=70 years
- Weight change < 5 kg in last 6 months
- HbA1c level <= 8%
- Patients with prediabetes (Impaired glucose tolerance and impaired fasting glycaemia) or type 2 diabetes (diet controlled or on oral therapy)
- Patients will have to be on oral therapy for diabetes (without changes in treatment) at least for 3 months.
- Patients will be advised not to change their pre-existing therapy for diabetes and cardiovascular risk factors for the duration of the study if HbA1c is not above 8%
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- No recent blood transfusion (3 months)
- No current intake of anti-inflammatory medications and supplements
- No significant kidney, cardiovascular, haematological, respiratory, gastrointestinal, 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)
- Pregnant or lactating
Who cannot join
- Age <18 or > 70 years
- HbA1c level of >= 8%
- Weight change > 5 kg in last 6 months
- Morbid obesity (body mass index >40 kg/m2)
- Current smoking habit and high alcohol use
- Patients on insulin
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- Taking anti-inflammatory medications or supplements
- Recent blood transfusion history
- Kidney (estimated glomerular filtration rate < 30 ml/min), cardiovascular, haematological, respiratory, gastrointestinal, 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
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Monash Centre for Health Research and Implementation
Melbourne, Victoria, 3168
Barbora de Courten, MD,PHD,MPH, +61 3 857 22651, barbora.decourten@monash.edu
Barbora de Courten, MD,PHD,MPH
About this study
Official title: The Potential of Carnosine Supplementation in Optimising Cardiometabolic Health in Patients With Prediabetes and Type 2 Diabetes: a Randomsied, Double-blinded, Placebo-controlled Trial
The investigators hypothesise that carnosine supplementation will improve:
- glycaemic control
- cardiovascular risk factors
- cognitive outcomes in patients with prediabetes and type 2 diabetes, and this will be modulated by reduction in chronic low grade inflammation, oxidative stress and circulating advanced glycation end products levels.
- Aims
Read more
To determine the potential of carnosine supplementation for 14 weeks to improve glycaemic control in type 2 diabetes, reduce risk factors for cardiovascular disease and improve cognitive function as well as identify metabolic pathways involved, specifically by:
- Improving glycaemic control (HBA1c, fasting and 2 hour glucose and glucose area under the curve after oral glucose tolerance test)
- Reducing cardiovascular risk factors (lipids; arterial (aortic) stiffness; central blood pressure (cBP); endothelial function).
- Improve cognitive function (global cognitive score formed by a composite of 4 cognitive tests)
- Decrease the chronic low grade inflammation, oxidative stress, advanced glycation end products, and advanced lipoxidation end products, and increase detoxification of reactive carbonyl species (RCSs).
Read the detailed description
Type 2 diabetes is a major public health problem worldwide. Obesity itself markedly increases the risk of type 2 diabetes (DM2), which now affects every second obese person. With 60% of adult Australians overweight or obese and 25% of Australians aged over 25 years having prediabetes or diabetes, the quality-of-life and cost impact is inescapable. In Australia, direct healthcare costs for DM2 are currently estimated as $1.1 billion annually, with the prospect of doubling by 2025. Obesity and DM2 dramatically increase the risk of cardiovascular disease (CVD) with ~80% of individuals with both obesity and DM2 develop CVD. The annual healthcare costs for CVD in Australia now amount to $7.7 billion; and the total aggregated costs, including loss of income, are much higher again. Treating DM2 and CVD is expensive and often unsatisfactory. Weight loss and exercise are the mainstay of prevention and therapy but they are difficult and costly to achieve on a large scale; hence the DM2 epidemic continues unabated. Therefore, interventions at low cost and easy to implement at the population level is urgently required.
Neurodegenerative diseases often occurs in people with DM2, and DM2 is in turn associated with increased risk of cognitive decline. Neurodegenerative diseases such as Alzheimer's disease are also associated with metabolic impairment. They share many common pathogenic features with DM2 such as insulin resistance, chronic low-grade inflammation, vascular disease, oxidative stress and accumulation of advanced glycation endproducts (AGEs). Progression of these diseases over years-decades is also worsened by a sedentary life-style. Therefore not surprisingly, regular physical activity is beneficial in those patients, likely due to improvement of neurological, motor and cardiometabolic profile. However, it is difficult and costly to achieve on a large scale, and thus, safe and low-cost strategies are needed.
Type 2 diabetes is associated with increased amounts of ectopic fat depots in muscle including intramyocellular lipids (IMCL), and adipocytes located between muscle groups (inter-muscular) and also between muscle fascicles (intramuscular). Both IMCL and intra- and inter-muscular adipose tissue (IMAT) may deleteriously effect muscle metabolism and insulin sensitivity through increased local secretion of pro-inflammatory adipokines, and inter-muscular fat may additionally impair insulin action through reductions in blood flow to muscle.
Could carnosine be that strategy? Strong molecular and animal data (>2000 papers) suggests that it has great potential, with all the relevant properties. Carnosine, is present in several tissues including muscle and brain, easily crosses the blood-brain barrier, and extensive animal data show that carnosine has chelating properties and modulates glucose metabolism, advanced glycation, pro-inflammatory and pro-oxidative states, as well as motor functions and neurotransmission. A promising further use may derive from its effect on cardiometabolic health and neuroprotection. Current research, confined to animal studies, supports carnosine supple¬ment¬ation for preventing and treating obesity, DM2, CVD, and neurodegenerative diseases - by virtue of its anti-inflammatory, antioxidative, anti-glycating and chelating effects. Our team's novel pilot studies provide the first human cross-sectional and interventional metabolic data, and demonstrate relationships among carnosine, obesity, insulin resistance, and dyslipidaemia. Previous clinical trials also showed that supplementation of carnosine for 2-3 months improved cognitive performance in healthy individuals and patients with neurodegenerative diseases. However, none of them showed its effect in patient with type 2 diabetes and explored the effects of change in cardiometabolic outcomes on cognitive function.
Apart from its excellent side-effect profile, carnosine is cheap and safe (it is an over-the-counter dietary supplement), making it prima facie ideal for widespread, low cost use. Robust human research is now urgently needed to test the therapeutic potential of carnosine in improving cardiometabolic profile and cognitive function, and study the mechanisms involved.
- Being tested
- carnosine, Placebo
- Keywords
- carnosine, type 2 diabetes, cardiovascular factors
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carnosineDietary supplement
Also called Pure Carnosine
Each participant will be given a daily oral dose 2 g of carnosine (4 tablets of 500mg each) for 14 weeks
PlaceboDrug
Also called Methylcellulose
Each participant will be given a daily oral dose 2 g of placebo (4 tablets of 500mg each) for 14 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Each participant will be given a daily oral dose 2 g of carnosine (4 tablets of 500mg each) for 14 weeks Receives: Dietary Supplement: carnosine |
| Control | Placebo comparator | Each participant will be given a daily oral dose 2 g of placebo (4 tablets of 500mg each) for 14 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oral Glucose Tolerance Test
After a 10-12 h overnight fast, participants will ingest 75g of glucose over 2 mins. Blood samples will be drawn at 0, 30, 60, 90 and 120 min for plasma glucose and insulin concentrations. We will evaluate the area under the curve.
Measured: baseline and 14 weeks
Secondary outcomes (13)
Change in HbA1c
Blood samples will be measured using High Performance Liquid Chromatography.
Measured: baseline and 14 weeks
Change in lipid profile
Blood samples will be analysed using High Performance Liquid Chromatography
Measured: baseline and 14 weeks
Change in 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.
Measured: baseline and 14 weeks
Change in arterial stiffness and central blood pressure
Aortic (carotid-femoral) pulse wave velocity (aPWV) will be measured using the non-invasive Complior device (Alam Medical, French).
Measured: baseline and 14 weeks
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 plethysmographic signals of the finger arterial pulse wave. Finger plethysmographic probes are placed on each index finger; and after a 5 min equilibration 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).
Measured: baseline and 14 weeks
Change in heart rate variability
The Zephyr Biomodule BH3 (Black Sensor, produced by Zephyr Technology) will be used to measure heart rate and heart rate variability for three consecutive days.
Measured: baseline and 14 weeks
Change in interleukins
Interleukins will be measured by quantitative sandwich enzyme immunoassays (R \& D Systems Inc, USA).
Measured: baseline and 14 weeks
Change in tumour necrosis factor α
Tumour necrosis factor α (TNFα) will be measured by quantitative sandwich enzyme immunoassays (R \& D Systems Inc, USA).
Measured: baseline and 14 weeks
Change in macrophage migration inhibitory factor
Macrophage migration inhibitory factor will be measured by quantitative sandwich enzyme immunoassays (R \& D Systems Inc, USA).
Measured: baseline and 14 weeks
Change in plasma C- reactive protein
Plasma C- reactive protein (hsCRP) will be measured using high sensitivity assay (BN-II nephelometer; Dade Behring Diagnostics, NSW).
Measured: baseline and 14 weeks
Change in plasma and urinary advanced glycation end products
Measured by liquid chromatography-tandem mass spectrometry and ELISA tests. Circulating receptor for AGEs will be measured by ELISA. Protein modifications and the effect of carnosine supplementation will be determined by proteomic approaches.
Measured: baseline and 14 weeks
Change in plasma and urinary advanced lipoxidation end products
This will be determined by measuring the advanced oxidation protein products and by measuring the cysteinate form of albumin by mass spectrometry. Mercapturic acid adducts with the main reactive carbonyls species will also be quantitatively determined by liquid chromatography electrospray ionization mass spectrometry/mass spectrometry analysis (LC-MS/MS).
Measured: baseline and 14 weeks
Change in general cognitive function
Participants' cognitive function will be assessed using Cambridge Neuropsychological Test Automated Battery (CANTAB) battery for Prodromal Alzheimer's disease, Victoria Stroop test, Trail Making Test and Digit Symbol Substitution Test.
Measured: baseline and 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Poor Glycemic ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbora de Courten, Monash University
- Investigators
- Barbora de courten, MD,PHD,MPH, Principal investigator, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917928
- Sponsor's protocol ID
- 16061AI
- Status last verified
- Jun 2022
- First submitted
- 19 Sep 2016
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kabthymer RH, Feehan J, Mousa A, Aldini G, de Courten M, Cameron J, de Courten B. The Effect of Carnosine Supplementation on Depressive Symptoms and Health-Related Quality of Life in Individuals With Prediabetes and Well-Controlled Type 2 Diabetes: A Randomized Controlled Trial. Food Sci Nutr. 2026 Feb 25;14(3):e71514. doi: 10.1002/fsn3.71514. eCollection 2026 Mar.
PubMed 41767833Saadati S, Jansons P, Scott D, de Courten M, Mousa A, Feehan J, Mesinovic J, de Courten B. The Effect of Carnosine Supplementation on Musculoskeletal Health in Adults with Prediabetes and Type 2 Diabetes: A Secondary Analysis of a Randomized Controlled Trial. Nutrients. 2024 Dec 15;16(24):4328. doi: 10.3390/nu16244328.
PubMed 39770949Saadati S, de Courten M, Deceneux C, Plebanski M, Scott D, Mesinovic J, Jansons P, Aldini G, Cameron J, Feehan J, Mousa A, de Courten B. Carnosine Supplementation Has No Effect on Inflammatory Markers in Adults with Prediabetes and Type 2 Diabetes: A Randomised Controlled Trial. Nutrients. 2024 Nov 15;16(22):3900. doi: 10.3390/nu16223900.
PubMed 39599686Saadati S, Cameron J, Menon K, Hodge A, Lu ZX, de Courten M, Feehan J, de Courten B. Carnosine Did Not Affect Vascular and Metabolic Outcomes in Patients with Prediabetes and Type 2 Diabetes: A 14-Week Randomized Controlled Trial. Nutrients. 2023 Nov 19;15(22):4835. doi: 10.3390/nu15224835.
PubMed 38004228Baye E, Menon K, de Courten MP, Earnest A, Cameron J, de Courten B. Does supplementation with carnosine improve cardiometabolic health and cognitive function in patients with pre-diabetes and type 2 diabetes? study protocol for a randomised, double-blind, placebo-controlled trial. BMJ Open. 2017 Sep 1;7(9):e017691. doi: 10.1136/bmjopen-2017-017691.
PubMed 28864708
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential of Carnosine Supplementation in Optimising Cardiometabolic Health in Patients With Prediabetes and Type 2 Diabetes: a Randomsied, Double-blinded, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02917928
- Acronym / sponsor ID
- 16061AI
- Keywords
- carnosine, type 2 diabetes, cardiovascular factors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 28 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesise that carnosine supplementation will improve:
- glycaemic control
- cardiovascular risk factors
- cognitive outcomes in patients with prediabetes and type 2 diabetes, and this will be modulated by reduction in chronic low grade inflammation, oxidative stress and circulating advanced glycation end products levels.
- Aims
To determine the potential of carnosine supplementation for 14 weeks to improve glycaemic control in type 2 diabetes, reduce risk factors for cardiovascular disease and improve cognitive function as well as identify metabolic pathways involved, specifically by:
- Improving glycaemic control (HBA1c, fasting and 2 hour glucose and glucose area under the curve after oral glucose tolerance test)
- Reducing cardiovascular risk factors (lipids; arterial (aortic) stiffness; central blood pressure (cBP); endothelial function).
- Improve cognitive function (global cognitive score formed by a composite of 4 cognitive tests)
- Decrease the chronic low grade inflammation, oxidative stress, advanced glycation end products, and advanced lipoxidation end products, and increase detoxification of reactive carbonyl species (RCSs).
Detailed description
Type 2 diabetes is a major public health problem worldwide. Obesity itself markedly increases the risk of type 2 diabetes (DM2), which now affects every second obese person. With 60% of adult Australians overweight or obese and 25% of Australians aged over 25 years having prediabetes or diabetes, the quality-of-life and cost impact is inescapable. In Australia, direct healthcare costs for DM2 are currently estimated as $1.1 billion annually, with the prospect of doubling by 2025. Obesity and DM2 dramatically increase the risk of cardiovascular disease (CVD) with ~80% of individuals with both obesity and DM2 develop CVD. The annual healthcare costs for CVD in Australia now amount to $7.7 billion; and the total aggregated costs, including loss of income, are much higher again. Treating DM2 and CVD is expensive and often unsatisfactory. Weight loss and exercise are the mainstay of prevention and therapy but they are difficult and costly to achieve on a large scale; hence the DM2 epidemic continues unabated. Therefore, interventions at low cost and easy to implement at the population level is urgently required.
Neurodegenerative diseases often occurs in people with DM2, and DM2 is in turn associated with increased risk of cognitive decline. Neurodegenerative diseases such as Alzheimer's disease are also associated with metabolic impairment. They share many common pathogenic features with DM2 such as insulin resistance, chronic low-grade inflammation, vascular disease, oxidative stress and accumulation of advanced glycation endproducts (AGEs). Progression of these diseases over years-decades is also worsened by a sedentary life-style. Therefore not surprisingly, regular physical activity is beneficial in those patients, likely due to improvement of neurological, motor and cardiometabolic profile. However, it is difficult and costly to achieve on a large scale, and thus, safe and low-cost strategies are needed.
Type 2 diabetes is associated with increased amounts of ectopic fat depots in muscle including intramyocellular lipids (IMCL), and adipocytes located between muscle groups (inter-muscular) and also between muscle fascicles (intramuscular). Both IMCL and intra- and inter-muscular adipose tissue (IMAT) may deleteriously effect muscle metabolism and insulin sensitivity through increased local secretion of pro-inflammatory adipokines, and inter-muscular fat may additionally impair insulin action through reductions in blood flow to muscle.
Could carnosine be that strategy? Strong molecular and animal data (>2000 papers) suggests that it has great potential, with all the relevant properties. Carnosine, is present in several tissues including muscle and brain, easily crosses the blood-brain barrier, and extensive animal data show that carnosine has chelating properties and modulates glucose metabolism, advanced glycation, pro-inflammatory and pro-oxidative states, as well as motor functions and neurotransmission. A promising further use may derive from its effect on cardiometabolic health and neuroprotection. Current research, confined to animal studies, supports carnosine supple¬ment¬ation for preventing and treating obesity, DM2, CVD, and neurodegenerative diseases - by virtue of its anti-inflammatory, antioxidative, anti-glycating and chelating effects. Our team's novel pilot studies provide the first human cross-sectional and interventional metabolic data, and demonstrate relationships among carnosine, obesity, insulin resistance, and dyslipidaemia. Previous clinical trials also showed that supplementation of carnosine for 2-3 months improved cognitive performance in healthy individuals and patients with neurodegenerative diseases. However, none of them showed its effect in patient with type 2 diabetes and explored the effects of change in cardiometabolic outcomes on cognitive function.
Apart from its excellent side-effect profile, carnosine is cheap and safe (it is an over-the-counter dietary supplement), making it prima facie ideal for widespread, low cost use. Robust human research is now urgently needed to test the therapeutic potential of carnosine in improving cardiometabolic profile and cognitive function, and study the mechanisms involved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Dietary Supplement: carnosineEach participant will be given a daily oral dose 2 g of carnosine (4 tablets of 500mg each) for 14 weeks |
| Control | Placebo comparator | Drug: PlaceboEach participant will be given a daily oral dose 2 g of placebo (4 tablets of 500mg each) for 14 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age >=18 or <=70 years
- Weight change < 5 kg in last 6 months
- HbA1c level <= 8%
- Patients with prediabetes (Impaired glucose tolerance and impaired fasting glycaemia) or type 2 diabetes (diet controlled or on oral therapy)
- Patients will have to be on oral therapy for diabetes (without changes in treatment) at least for 3 months.
Key exclusion criteria (10 listed)
- Age <18 or > 70 years
- HbA1c level of >= 8%
- Weight change > 5 kg in last 6 months
- Morbid obesity (body mass index >40 kg/m2)
- Current smoking habit and high alcohol use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carnosineAlso: Pure CarnosineEach participant will be given a daily oral dose 2 g of carnosine (4 tablets of 500mg each) for 14 weeks | Dietary supplement | Intervention |
| PlaceboAlso: MethylcelluloseEach participant will be given a daily oral dose 2 g of placebo (4 tablets of 500mg each) for 14 weeks | Drug | Control |
Primary outcome
Change in Oral Glucose Tolerance Test
Time frame: baseline and 14 weeks
After a 10-12 h overnight fast, participants will ingest 75g of glucose over 2 mins. Blood samples will be drawn at 0, 30, 60, 90 and 120 min for plasma glucose and insulin concentrations. We will evaluate the area under the curve.
13 secondary outcomes
Change in HbA1c
Time frame: baseline and 14 weeks
Change in lipid profile
Time frame: baseline and 14 weeks
Change in systolic and diastolic blood pressure
Time frame: baseline and 14 weeks
Change in arterial stiffness and central blood pressure
Time frame: baseline and 14 weeks
Change in markers of endothelial dysfunction
Time frame: baseline and 14 weeks
Change in heart rate variability
Time frame: baseline and 14 weeks
Change in interleukins
Time frame: baseline and 14 weeks
Change in tumour necrosis factor α
Time frame: baseline and 14 weeks
Change in macrophage migration inhibitory factor
Time frame: baseline and 14 weeks
Change in plasma C- reactive protein
Time frame: baseline and 14 weeks
Change in plasma and urinary advanced glycation end products
Time frame: baseline and 14 weeks
Change in plasma and urinary advanced lipoxidation end products
Time frame: baseline and 14 weeks
Change in general cognitive function
Time frame: baseline and 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Derived from this study: PubMed 41767833Kabthymer RH, Feehan J, Mousa A, Aldini G, de Courten M, Cameron J, de Courten B. The Effect of Carnosine Supplementation on Depressive Symptoms and Health-Related Quality of Life in Individuals With Prediabetes and Well-Controlled Type 2 Diabetes: A Randomized Controlled Trial. Food Sci Nutr. 2026 Feb 25;14(3):e71514. doi: 10.1002/fsn3.71514. eCollection 2026 Mar.
- Derived from this study: PubMed 39770949Saadati S, Jansons P, Scott D, de Courten M, Mousa A, Feehan J, Mesinovic J, de Courten B. The Effect of Carnosine Supplementation on Musculoskeletal Health in Adults with Prediabetes and Type 2 Diabetes: A Secondary Analysis of a Randomized Controlled Trial. Nutrients. 2024 Dec 15;16(24):4328. doi: 10.3390/nu16244328.
- Derived from this study: PubMed 39599686Saadati S, de Courten M, Deceneux C, Plebanski M, Scott D, Mesinovic J, Jansons P, Aldini G, Cameron J, Feehan J, Mousa A, de Courten B. Carnosine Supplementation Has No Effect on Inflammatory Markers in Adults with Prediabetes and Type 2 Diabetes: A Randomised Controlled Trial. Nutrients. 2024 Nov 15;16(22):3900. doi: 10.3390/nu16223900.
- Derived from this study: PubMed 38004228Saadati S, Cameron J, Menon K, Hodge A, Lu ZX, de Courten M, Feehan J, de Courten B. Carnosine Did Not Affect Vascular and Metabolic Outcomes in Patients with Prediabetes and Type 2 Diabetes: A 14-Week Randomized Controlled Trial. Nutrients. 2023 Nov 19;15(22):4835. doi: 10.3390/nu15224835.
- Derived from this study: PubMed 28864708Baye E, Menon K, de Courten MP, Earnest A, Cameron J, de Courten B. Does supplementation with carnosine improve cardiometabolic health and cognitive function in patients with pre-diabetes and type 2 diabetes? study protocol for a randomised, double-blind, placebo-controlled trial. BMJ Open. 2017 Sep 1;7(9):e017691. doi: 10.1136/bmjopen-2017-017691.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbora de courten, MD,PHD,MPH principal investigator
Monash University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing carnosine in people with Poor Glycemic Control and Cardiovascular Risk Factors, run by Monash University at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbora de Courten, MD,PHD,MPH (+61 385722651, barbora.decourten@monash.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oral Glucose Tolerance Test (time frame: baseline and 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02917928, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022; AzTrials last refreshed its copy on 8 Nov 2026.