The Potential of Carnosine Supplementation in Optimising Cardiometabolic Health

NCT02917928 | Unknown Phase 2 DMC

• 1 other identifier: 16061AI
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesise that carnosine supplementation will improve:

1. 1.glycaemic control
2. 2.cardiovascular risk factors
3. 3.cognitive outcomes
4. 4.Improving glycaemic control (HBA1c, fasting and 2 hour glucose and glucose area under the curve after oral glucose tolerance test)
5. 5.Reducing cardiovascular risk factors (lipids; arterial (aortic) stiffness; central blood pressure (cBP); endothelial function).
6. 6.Improve cognitive function (global cognitive score formed by a composite of 4 cognitive tests)
7. 7.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).

Conditions

Poor Glycemic Control; Cardiovascular Risk Factors; Cognitive Function 1, Social

Keywords

carnosine, type 2 diabetes, cardiovascular factors

Outcome Measures

Primary Outcomes (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.

  baseline and 14 weeks

Secondary Outcomes (13)

• Change in HbA1c

  baseline and 14 weeks

• Change in lipid profile

  baseline and 14 weeks

• Change in systolic and diastolic blood pressure

  baseline and 14 weeks

• Change in arterial stiffness and central blood pressure

  baseline and 14 weeks

• Change in markers of endothelial dysfunction

  baseline and 14 weeks

Other Outcomes (4)

• Change in liver stiffness and fat

  baseline and 14 weeks

• Change in Serum and urine carnosine

  baseline and 14 weeks

• Change in skeletal muscle fat and density

  baseline and 14 weeks

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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

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

Drug: Placebo

Interventions

carnosine DIETARY_SUPPLEMENT

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

Also known as: Pure Carnosine

Intervention

Placebo DRUG

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

Also known as: Methylcellulose

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Monash University: lead

Study Sites (1)

Monash Centre for Health Research and Implementation

Melbourne, Victoria, 3168, Australia

RECRUITING

Related Publications (4)

• 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.

  PMID: 39770949 DERIVED

• 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.

  PMID: 39599686 DERIVED

• 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.

  PMID: 38004228 DERIVED

• 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.

  PMID: 28864708 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Carnosine; Methylcellulose

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Dipeptides; Oligopeptides; Nerve Tissue Proteins; Proteins; Cellulose; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Barbora de courten, MD,PHD,MPH

  Monash University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbora de Courten, MD,PHD,MPH

CONTACT

+61 385722651; barbora.decourten@monash.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 19, 2016
• First Posted: September 28, 2016
• Study Start: October 1, 2016
• Primary Completion: January 1, 2023
• Study Completion: July 1, 2023
• Last Updated: June 28, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)