The Potential of Carnosine Supplementation in Optimising Cardiometabolic Health

• Status: Unknown status
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Monash University

Criteria

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