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Technical – Clinical Trials

MediKane is a true “Food as Medicine” company. Unlike health food companies and most supplement sellers, MediKane creates products to treat specific conditions then validates the product benefits with scientific and clinical trials.

BACKGROUND

The medical benefits of the NutriKane product range have now been extensively trialled both scientifically and medically. This demonstrates NutriKane’s effectiveness in:

  • Improving control of blood sugar levels
  • statistically reducing hyperglycaemia compared to diet and exercise alone
  • Reducing systemic inflammation
  • Improving intestinal health
  • Feeding and nurturing the microbiome (broad spectrum pre-biotic)
  • Lowering the glycaemic index of foods when consumed with a meal
  • Reducing length of stay at hospitals after surgery
  • Reducing the length and severity of constipation and faecal incontinence during hospital stays
  • Reducing the incidence and severity of chronic constipation
  • Reducing the incidence and severity of opioid induced constipation
  • Increased weight loss compared to diet and exercise alone

 

The products have proven benefits for relieving the symptoms of various conditions such as:

  • High BSLs and other metabolic disorder management
  • Constipation caused by extended hospital stay (HIC) and/or the use of opioid analgesic painkillers (OIC)
  • Chronic constipation
  • Irritable Bowel Syndrome (IBS)
  • Reflux

The MediKane team has partnered with Royal Melbourne Hospital, Royal North Shore Hospital, The University of Melbourne, Monash University, the Queensland University of Technology, Sydney University, Macquarie University, a hospital group in Chicago USA as well as several independent practitioners to fully establish the benefits of the NutriKane product range.  Some Hospital studies are described below.

Constipation:

  • A 100 patient, open label longitudinal pre-post study examining the benefits of a management program using NutriKane+ on individuals admitted to rehabilitation care noted an 88% improvement in bowel function (both constipation and faecal incontinence) compared to their time of admission. Over 80% of the participants were using a fibre supplement to treat their constipation and 50% were using stimulant laxatives without effect before being successfully treated with NutriKane+. At 3 months post discharge 88% of participants reported that bowel function was still normal indicating treatment translated to an uncontrolled environment.
  • A 50 patient randomised controlled trial of Spina Bifida patients to assess the effectiveness of a program that included NutriKane+ over normal standard of care. The study found that participants in the intervention group had significant benefits to intestinal function (including reduction in constipation and faecal incontinence), cognitive function, Quality of Life (formal assessment), bladder function and overall ability to cope. At 3 months post discharge, 55% of participants indicated that these indicators were still improved suggesting results could translate into real world, uncontrolled environments.
  • A 31 patient open label randomised head to head study comparing NutriKane+ to pharmaceutical interventions or no treatment. NutriKane+ resulted in comparable results to pharmaceutical interventions at 6% of cost to patient/hospital. Both interventions were significantly improved over control.
  • A 66 patient randomised blinded head to head trial of trauma patients using NutriKane+ vs normal standard of care resulted in shorter length of stay, time to return of bowel function and lower need of additional treatment.
  • To-date, 5 hospitals in Australia conducted head to head trials of varying protocols comparing to their own normal standard of care and found NutriKane resulted in improvement of outcomes in all cases.

Blood glucose and weight management:

A 50-patient randomised, blinded placebo controlled trial of NutriKane vs diet and exercise alone. The trial involved 2 phases – a tightly controlled period in hospital where all factors were accounted for and diet and exercise controlled, followed by a 3 month “at home” period where patients were advised, but not controlled:    

  • Significant (2.2 x) difference in the reduction of fasting blood glucose between the control and NutriKane groups. BMI reduction of 1.1 for the NutriKane group compared to 0.1 for the control group.
  • Significant improvement in measures of blood glucose management and quality of life for the NutriKane group compared to the control group.
  • Increased compliance of all management parameters when NutriKane was included as part of the regimen.
  • At 3 months follow up, the control group had returned to baseline while improvements were still observed in the NutriKane group.

A 100 participant randomised blinded trial of diet and exercise alone vs diet, exercise and NutriKane supplementation for an 8-week high level weight loss program that included moderate to high levels of exercise and diet control.  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 in the trial that were living with high BSLs  observed better BSL control during the 8 weeks and had reduced HbA1c at their next check-up.

Other Studies

  • Standard Glycaemic Index (GI) trials showed that NutriKane lowers the GI of 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 reduction was often significant enough to make High and Medium GI meals to become low GI meals. Reducing the glycaemic index of a meal is a well established strategy for improving blood glucose control.
  • Several practitioner-led case studies have observed greatly improved blood sugar management, both in reduction of high and low blood sugar finger prick readings and a general reduction in HbA1c levels in the range of 0.3 to 5 points. These reductions have on occasion resulted in doctors recommending a reduction of both oral medication and exogenous insulin (exogenous insulin refers to the insulin people inject or infuse via an insulin pump – compared to endogenous insulin, which is what the pancreas makes naturally). In some cases, doctors have reduced medication in their patients to the point that use was eliminated. These trials have been ongoing for up to 8 years without any observed habituation. 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.
  • Pre-clinical animal trials at Royal North Shore Hospital in 2019 demonstrated that NutriKane provided significant benefits to subjects with Type 1 diabetes. Further work is being done in this area. These results are fully consistent with customer feedback who experienced improved control and a reduction of hypoglycaemic events, both in frequency and intensity.

Proposed and Ongoing Trials

  • A full clinical trial at the Royal North Shore Hospital is proposed to test the effect of NutriKane D on Chronic Kidney Disease (CKD) in patients with diabetes following on from anti-inflammatory data generated at Macquarie University.  This will open a new market for MediKane.
  • A trial of NutriKane D eliminating or reducing the symptoms of gestational diabetes. There is a strong desire for non-pharmaceutical management of diabetes in pregnancy and as NutriKane is known to reduce constipation and reflux as well as manage blood glucose levels it is an ideal candidate.
  • An exploratory trial measuring NutriKane’s benefit to diverticulitis – opening a new market for MediKane.
  • An exploratory trial measuring  NutriKane’s ability to reduce or eliminate the symptoms of  chronic abdominal pain – opening a new market for MediKane.
  • Further clinical trials are planned in the USA to build US credibility into the products and brand. The trials will be repeats of the Australian trials and will be valuable as product credibility for US medical and drug store sales.