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Trial · Interventional

Status unknownPhase 2Registry data

The Potential of Carnosine Supplementation in Optimising Cardiometabolic Health

NCTNCT02917928 (opens ClinicalTrials.gov in a new tab)Other id16061AI
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 2
Enrollment
40 participants (estimated)
Sponsor
Monash University · Other
Design
Randomized · Quadruple masking
Countries
1 country

Australia

Start
Oct 2016
Primary completion
Jan 2023 (estimated)
Completion
Jul 2023 (estimated)
First posted
28 Sept 2016 (estimated)
Last update posted
28 Jun 2022
Conditions
Poor Glycemic Control · Cardiovascular Risk Factors · Cognitive Function 1, Social

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20162018202020222024
  1. Ph 2

    The Potential of Carnosine Supplementation in Optimising Cardiometabolic Health

    NCT02917928

    Oct 2016 to est. Jul 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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. 3\. 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: 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).

Interventions

  • carnosineDietary supplement
  • PlaceboDrug

Arms2

  • Active comparator

    Intervention

    Each participant will be given a daily oral dose 2 g of carnosine (4 tablets of 500mg each) for 14 weeks

  • Placebo comparator

    Control

    Each participant will be given a daily oral dose 2 g of placebo (4 tablets of 500mg each) for 14 weeks

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Oral Glucose Tolerance Test

    Time frame · baseline and 14 weeks

    Registry description

    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.

Secondary outcomes(13)

  1. Change in HbA1c

    Time frame · baseline and 14 weeks

    Registry description

    Blood samples will be measured using High Performance Liquid Chromatography.

  2. Change in lipid profile

    Time frame · baseline and 14 weeks

    Registry description

    Blood samples will be analysed using High Performance Liquid Chromatography

  3. Change in systolic and diastolic blood pressure

    Time frame · baseline and 14 weeks

    Registry description

    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.

  4. Change in arterial stiffness and central blood pressure

    Time frame · baseline and 14 weeks

    Registry description

    Aortic (carotid-femoral) pulse wave velocity (aPWV) will be measured using the non-invasive Complior device (Alam Medical, French).

  5. Change in markers of endothelial dysfunction

    Time frame · baseline and 14 weeks

    Registry description

    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).

  6. Change in heart rate variability

    Time frame · baseline and 14 weeks

    Registry description

    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.

  7. Change in interleukins

    Time frame · baseline and 14 weeks

    Registry description

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

  8. Change in tumour necrosis factor α

    Time frame · baseline and 14 weeks

    Registry description

    Tumour necrosis factor α (TNFα) will be measured by quantitative sandwich enzyme immunoassays (R \& D Systems Inc, USA).

  9. Change in macrophage migration inhibitory factor

    Time frame · baseline and 14 weeks

    Registry description

    Macrophage migration inhibitory factor will be measured by quantitative sandwich enzyme immunoassays (R \& D Systems Inc, USA).

  10. Change in plasma C- reactive protein

    Time frame · baseline and 14 weeks

    Registry description

    Plasma C- reactive protein (hsCRP) will be measured using high sensitivity assay (BN-II nephelometer; Dade Behring Diagnostics, NSW).

  11. Change in plasma and urinary advanced glycation end products

    Time frame · baseline and 14 weeks

    Registry description

    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.

  12. Change in plasma and urinary advanced lipoxidation end products

    Time frame · baseline and 14 weeks

    Registry description

    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).

  13. Change in general cognitive function

    Time frame · baseline and 14 weeks

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies5

Studies that cite this trial.

Studies with results

4 studies on this page

PubMed tag: none · 2026

3 results

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.

Kabthymer et al. 2026Food science & nutrition

PMID 41767833PMC12935567DOI 10.1002/fsn3.71514PUB-41767833

CC BY3 results
Download PDFSee results (3)

Indexing hint: Randomized controlled trial · 2024

10 results

Carnosine Supplementation Has No Effect on Inflammatory Markers in Adults with Prediabetes and Type 2 Diabetes: A Randomised Controlled Trial.

Saadati et al. 2024Nutrientscited by 6

PMID 39599686PMC11597812DOI 10.3390/nu16223900PUB-39599686

CC BY10 results
Download PDFSee results (10)

Indexing hint: Randomized controlled trial · 2024

8 results

The Effect of Carnosine Supplementation on Musculoskeletal Health in Adults with Prediabetes and Type 2 Diabetes: A Secondary Analysis of a Randomized Controlled Trial.

Saadati et al. 2024Nutrientscited by 3

PMID 39770949PMC11677094DOI 10.3390/nu16244328PUB-39770949

CC BY8 results
Download PDFSee results (8)

Indexing hint: Randomized controlled trial · 2023

10 results

Carnosine Did Not Affect Vascular and Metabolic Outcomes in Patients with Prediabetes and Type 2 Diabetes: A 14-Week Randomized Controlled Trial.

Saadati et al. 2023Nutrientscited by 12

PMID 38004228PMC10674211DOI 10.3390/nu15224835PUB-38004228

CC BY10 results
Download PDFSee results (10)

Indexing hint: Randomized controlled trial · 2017

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.

Baye et al. 2017BMJ opencited by 16

PMID 28864708PMC5588946DOI 10.1136/bmjopen-2017-017691PUB-28864708

Free to read · publisher termsCC BY-NC
Read at source

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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% * 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 Exclusion Criteria: * 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 * 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

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