Basis of MediKane’s Technical Innovation and Effectiveness
The medical benefits of the NutriKane product range have now been extensively trialled both scientifically and medically, and are now peer-reviewed and confirmed. This demonstrates NutriKanes effectiveness in lowering blood sugar levels in Diabetics and improving intestinal health.
The products have proven benefits for situations and conditions including:
- Diabetes and other metabolic disorder management
- Relief from constipation including Hospital post-operative constipation and OIC (Opioid Induced Constipation), that occurs with the use of opioid analgesic pain-killers
- Weight Management
- Improved intestinal health and relief from symptoms of Irritable Bowel Syndrome
Products are under development for a range of other conditions that have become global health problems. The products all comply with current consumer requirements of:
- Minimally processed
- Gluten Free
- Safe – no adverse side effects
- Cannot be overdosed
- Safe for both children and the elderly
The anti-diabetic properties of one of the key ingredients were discovered when elderly people were using it as a high fibre product to improve bowel function and regularity. Their GPs noted that those people using the product and also living with diabetes had experienced a marked improvement in both control of Blood Sugar Level (BSL) fluctuations and a reduction in HbA1c.
In addition, it was noted in a Glycaemic Index (GI) trial that when the ingredient was added to a meal it reduced the GI of a test meal to a significantly greater level than could be explained by the fibre alone.
The MediKane scientific team then expanded these trials and delved into the underlying mechanism of the ingredient to further refine dose response curves and improve specific outcomes with other food ingredients that are manufactured to medical food requirements.
The team has partnered with Macquarie University, Royal Melbourne Hospital, Royal North Shore Hospital, Monash University and the Queensland University of Technology as well as several independent practitioners to fully establish the benefits of the NutriKane Product range. Details of some of these collaborations are described below
The underlying mechanisms of the ingredients were analysed in conjunction with researchers at Macquarie University, Sydney, Australia. This work was partially funded by the Australian government under an Australian Research Council (ARC) grant.
This project which comprises 3 PhD theses and several scientific publications, found that NutriKane:
- Contains high levels of organic and bioavailable micronutrients such as chromium. These nutrients are in a form that can be readily absorbed and used for BSL and metabolism control (unlike artificial supplements)
- High levels of anti-oxidants from a number of different classes
- Clear evidence that NutriKane is a multi-level and effective Pre-biotic
- Feeding the bacteria shown to be beneficial to human health
- Impeding the growth on bacteria shown to be harmful to human health
- Promoting the production of Short Chain Fatty Acids (SCFA)
- NutriKane has direct and indirect anti-inflammatory action (through the microbiota in the gut).
- Animal models (mice diabetes model) have shown a protective effect (reduces the incidence and severity of a high fat diet on blood glucose control); an improvement in gut wall health (linked to many conditions ?such as IBS and IBD) and a more diverse microbiome with lower levels of pro-inflammatory bacteria.
This data has been submitted for publication in several peer reviewed journals and is expected to be published mid 2017.
A separate Weight Control Study was also conducted demonstrating significant weight loss for individuals on NutriKane:
- A dietitian led Weight Loss study was performed that analysed the benefits of NutriKane to a standard weight loss regimen. One hundred (100) individuals were enrolled in an 8 week high level weight loss program that included moderate to high levels of exercise and diet control. Half the group were also given NutriKane as part of their supplementation program but were blinded as to its significance. The study found that the NutriKane group lost almost twice as much weight as the control group over the 8 weeks (5.74kg in the control group compared to 10.19kg in the NutriKane group). NutriKane appeared to be equally beneficial to men and women. Participants also found it easier to maintain the diet control portion of the program. While not specifically tested, it was noted that those people living with diabetes in the trial observed better BSL control during the 8 weeks and had reduced HbA1c at their next check-up.
- MediKane expanded on the initial Glycaemic Index trial to confirm that the GI lowering effects of the products extended to solid meals, juices, protein drinks and mixed meals. The benefit was observed when NutriKane was included in the meal preparation, baked into bread and cakes or simply consumed in water with the meal. The average GI reduction was 19 points with a range of 15–36. The standard range of the GI scale is 0 – 100, so the result is very significant.
- Several practitioner led case studies have observed greatly improved blood glucose management in people living with diabetes, both in reduction of high and low blood glucose finger prick readings and a general reduction in HbA1c levels. These reductions have also resulted in a concurrent reduction of the need for medication in some cases eliminating the need for exogenous insulin or oral medications entirely. This trial was commenced four years before product launch without any apparent habituation. Additionally individuals have found weight management to be subjectively easier when taking NutriKane. The ongoing follow-up from customers and feedback anecdotally supports these controlled studies in a large number of subjects (100+).
- Practitioner led case studies have found several benefits to ongoing intestinal health including reduction in gastric reflux, reduction in IBS and IBD symptoms, general feelings of wellbeing etc. At this stage these have not been formally trialled. ?
- Two clinical trials have so far been conducted by Professor Fary Khan at the Royal Melbourne Hospital in Melbourne Australia. Both trials showed that NutriKane improved bowel function and regularity, and relieved hospital induced constipation significantly better than the normal standard of care.
- NutriKane was found to be effective even on patients that were using other forms of constipation relief without effect (including some using stimulant laxatives).
The Clinical Trial on NutriKane D was successful and demonstrated that NutriKane D helps people live with and manage diabetes. This is a breakthrough as no known “Food as Medicine” product or supplement has yet demonstrated its effectiveness on diabetes via the rigour of a clinical trial. In detail:
- Professor Khan observed improvements in the BSL of patients during the previous clinical trials on NutriKane+. This lead to the approval for a specific trial on the benefits of NutriKane D to recuperative care patients living with diabetes.
- This trial was a 50 person Randomised Clinical Trial (25 control and 25 intervention).
- It involved a controlled diet and exercise regimen that eliminated variables.
- The trial extends 3 month post hospital to assess the ongoing compliance and benefits.
- This trial was reported as a success in early March 2017 by Professor Khan and her medical team, and is currently being submitted for publication.
- Professor Khan has now expressed interest in continuing the trial to learn more about the effect of NutriKane D on diabetes patients generally.
- Royal North Shore hospital is running an exploratory trial on the effect of NutriKane D on Chronic ?Kidney Disease (CKD) in patients with diabetes as there is good evidence from the Macquarie university work that it will provide benefits in this area. This will open a new market for MediKane.
- Royal North Shore Hospital is planning on running a trial on the benefits of NutriKane D to gestational diabetes.
- A trial with the Baker IDI is in planning stage to show benefits to people with diabetes over a test meal (a GI test specifically using diabetics). ?
All case studies, published and unpublished data has been collected in an evidence pack for assessment.
- Peer review papers referring to the underlying science
- All internal trials and scientific observations
- Tabulated results
The evidence pack is not published but can be viewed by interested parties.
- The work of MediKane researchers with Macquarie university has led to a deeper understanding of the underlying mechanisms of metabolic health and how to treat metabolic disorders with medical foods. An understanding of the difference between “healthy” foods and foods that can be used to treat specific conditions has been able to be applied to several other ingredients and conditions. This has resulted in a library of ingredients that can be used to build on the basic benefits of the core ingredients found in NutriKane.
- The process of preparing the foods is not an obvious one. Others have attempted to prepare the core ingredients but the results showed no better effect than normal “fibre supplements”. The key requirements to prepare a food with active micronutrients has been kept as a trade secret and will be used for the creation of future products. ?