Insulin Sensitivity Clinical Trial
Official title:
The Potential of Carnosine Supplementation in Reducing the Cardiometabolic Risk: a Double-blind, Placebo-controlled Trial
The aim of this study is to determine whether carnosine supplementation in overweight/obese
individuals can improve insulin secretion and/or insulin resistance by decreasing sub
clinical inflammation.
The investigators hypothesise that carnosine supplementation will reduce type 2 diabetes and
cardiovascular risk factors by lowering chronic low-grade inflammation (CLI), oxidative
stress, advanced glycation end products (AGEs), and advanced lipoxidation end products
(ALEs).
Aim :To determine the capacity of carnosine supplementation to decrease major risk factors
for type 2 diabetes and cardiovascular disease and identify metabolic pathways involved,
specifically by:
1. Reducing diabetes risk (insulin sensitivity; secretory function and glucose tolerance)
2. Improving cardiovascular risk factors (lipids; arterial (aortic) stiffness; central
blood pressure (cBP); endothelial function).
3. Decreasing the CLI, oxidative stress, AGEs, and ALEs, and increase detoxification of
reactive carbonyl species (RCSs).
Cardiovascular risk factors including type 2 diabetes underpin a major threat to the globe
and result in a heavy health and financial burden across the healthcare system. Treating type
2 diabetes and cardiovascular disease is expensive and often unsatisfactory. Current
medications bring unwanted side effects, and often merely delay rather than prevent type 2
diabetes complications and cardiovascular disease. As a further concern, the micro- and
macrovascular complications of type 2 diabetes often start developing before actual
diagnosis. Diabetes prevention and treatment through weight loss and exercise programs is a
difficult and costly public health measure, leaving the tidal wave of type 2 diabetes to
swell even more. An alternative is urgently needed: a low-cost safe approach, easy to
implement at population level.
Could carnosine be that alternative? The evidence suggests carnosine has significant
metabolic impact and presents such an alternative. A naturally occurring dipeptide, carnosine
is already emerging as a human therapy in exercise physiology, heart failure, cataract
prevention and treatment, neurology, and psychiatry. A promising further use may derive from
its effect on cardiovascular risk factors. Metabolic research, though confined to animal
studies, strongly suggests that carnosine supplementation aids the prevention and treatment
of obesity, type 2 diabetes, and cardiovascular disease - by virtue of its anti-inflammatory,
antioxidative, and anti-glycating effects. The investigators conducted the first pilot data
in human and demonstrate relationships among carnosine, obesity, insulin resistance, and
dyslipidemia. Put briefly, the pilot weighs strongly in favour of carnosine as a means of
reducing cardiovascular risk in humans.
Too good to be true? Apart from its excellent side-effect profile, carnosine is inexpensive
and seemingly safe (available as an over-the-counter food additive), making it prima facie
ideal for population use. In this setting research is now urgently needed - to test the
significant metabolic potential of carnosine to address a major health problem.
The investigators propose a comprehensive double-blind placebo-controlled human trial to
investigate the effects of carnosine supplementation on cardiovascular risk factors. If the
investigators demonstrate a role in reducing risk factors for type 2 diabetes and
cardiovascular disease in overweight and obese non-diabetic humans, the public health
implications will be revolutionary, offering the world a genuine low cost, accessible,
intervention to curtail the advance of obesity, type 2 diabetes, and cardiovascular disease.
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