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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Barbora de Courten, MD,PHD,MPH contact

+61 385722651

barbora.decourten@monash.edu

Australia1 site, 1 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

    Recruiting

Other trials in Australia

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:

  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 glycation end products levels.
  4. 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:

  1. Improving glycaemic control (HBA1c, fasting and 2 hour glucose and glucose area under the curve after oral glucose tolerance test)
  2. Reducing cardiovascular risk factors (lipids; arterial (aortic) stiffness; central blood pressure (cBP); endothelial function).
  3. Improve cognitive function (global cognitive score formed by a composite of 4 cognitive tests)
  4. 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 groups in NCT02917928
Study groupRoleWhat they receive
InterventionActive comparatorEach participant will be given a daily oral dose 2 g of carnosine (4 tablets of 500mg each) for 14 weeks
Receives: Dietary Supplement: carnosine
ControlPlacebo comparatorEach 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.

  1. 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)
  1. Change in HbA1c

    Blood samples will be measured using High Performance Liquid Chromatography.

    Measured: baseline and 14 weeks

  2. Change in lipid profile

    Blood samples will be analysed using High Performance Liquid Chromatography

    Measured: baseline and 14 weeks

  3. 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

  4. 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

  5. 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

  6. 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

  7. Change in interleukins

    Interleukins will be measured by quantitative sandwich enzyme immunoassays (R \& D Systems Inc, USA).

    Measured: baseline and 14 weeks

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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.

  1. First posted28 Sep 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionJan 2023 (estimated)
  4. Study completionJul 2023 (estimated)

Resources

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)
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 41767833
  • Saadati 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 39770949
  • Saadati 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 39599686
  • Saadati 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 38004228
  • Baye 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

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.

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