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The Potential of Carnosine Supplementation in Optimising Cardiometabolic Health

NCT02917928 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-06-28

No results posted yet for this study

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 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).

Conditions

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

Interventions

DIETARY_SUPPLEMENT

carnosine

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

DRUG

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • Barbora de courten, MD,PHD,MPH · Monash University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2023-01-31
Completion
2023-07-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02917928 on ClinicalTrials.gov