The Potential of Carnosine Supplementation in Reducing the Cardiometabolic Risk
Açar sözlər
Mücərrəd
Təsvir
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.
Tarixlər
| Son Doğrulandı: | 02/28/2018 |
| İlk təqdim: | 02/08/2016 |
| Təxmini qeydiyyat təqdim edildi: | 02/14/2016 |
| İlk Göndərmə: | 02/21/2016 |
| Son Yeniləmə Göndərildi: | 03/19/2018 |
| Son Yeniləmə Göndərildi: | 03/21/2018 |
| Həqiqi Təhsilin Başlama Tarixi: | 02/12/2017 |
| Təxmini İlkin Tamamlanma Tarixi: | 02/12/2020 |
| Təxmini İşin Tamamlanma Tarixi: | 06/11/2020 |
Vəziyyət və ya xəstəlik
Müdaxilə / müalicə
Dietary Supplement: Intervention
Other: Control
Faza
Qol Qrupları
| Qol | Müdaxilə / müalicə |
|---|---|
| Active Comparator: Intervention Each participant will be given a daily oral dose 2 g of carnosine (2 tablets twice daily) for 14 weeks | Dietary Supplement: Intervention Carnosine capsules (2g) twice per day for 14 weeks |
| Placebo Comparator: Control Each participant will be given a daily oral dose 2 g of identical placebo tablets ( 2 tablets twice daily) for 14 weeks | Other: Control Placebo (methylcellulose) capsules for control group identical to intervention capsules and dose |
Uyğunluq Kriteriyaları
| Təhsil üçün uyğun yaşlar | 18 Years Üçün 18 Years |
| Təhsilə Uyğun Cinslər | All |
| Sağlam Könüllüləri qəbul edir | Bəli |
| Kriteriyalar | Inclusion Criteria: - Age >18 or <60 years, - Weight change < 5 kg in last 12 months - BMI >25kg/m2 but weight <159kg due to DEXA scan restrictions - Non-diabetic, no allergy, non-smoker, no high alcohol use - No current intake of medications including vitamin supplements - No kidney, cardiovascular, haematological, respiratory, gastrointestinal, endocrine 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) - Not pregnant or lactating Exclusion Criteria: - Age <18 or > 60 years - Weight change > 5 kg in last 12 months - Diabetes (diagnosed or oral glucose tolerance test (OGTT), allergy - Current smoking habit, high alcohol use - Current intake of medications including vitamin supplements - Kidney, cardiovascular, haematological, respiratory, gastrointestinal, endocrine 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 |
Nəticə
İlkin nəticə tədbirləri
1. Change in insulin sensitivity measured by euglycaemic glucose clamp [From baseline to 14 weeks]
İkincili Nəticə Tədbirləri
1. Change in markers of endothelial dysfunction [From baseline to 14 weeks]
2. Change in Acute Insulin Secretory Response - Intravenous Glucose Tolerance Test [From baseline to 14 weeks]
3. Change in Resting systolic and diastolic blood pressure [From baseline to 14 weeks]
Digər nəticə tədbirləri
1. Change in Arterial waveform measurement [From baseline to 14 weeks]
2. Change in Oral Glucose Tolerance Test -OGTT [From baseline to 14 weeks]
3. Change in Measure of Adiposity (DEXA) [From baseline to 14 weeks]
4. Change in plasma and urinary AGEs [From baseline to 14 weeks]
5. Change in plasma and urinary ALEs [From baseline to 14 weeks]
6. Change in inflammatory markers [From baseline to 14 weeks]
7. Change in Carnosine concentrations in skeletal muscle [From baseline to 14 weeks]
8. Change in Serum and urine carnosine [From baseline to 14 weeks]
9. Change in Plasma carnosinase protein content [From baseline to 14 weeks]
10. Change in Other Tissue Analyses [From baseline to 14 weeks]
