None listed
Conditions
Brief summary
Diabetes mellitus affects an estimated 451 million adults worldwide, and costs health systems US$850 billion annually. A cornerstone of effective diabetes management is maintaining optimum blood glucose control. However, less than half of people with diabetes reach their target ranges for blood glucose control. A relatively safe and low-cost therapy that is emerging as a promising treatment for diabetes is Olive Leaf Extract (OLE). While findings from laboratory studies indicate OLE may act on multiple metabolic pathways to improve blood glucose control, robust clinical research is needed in order to support the use of OLE in clinical practice. Researchers from the National Centre for Naturopathic Medicine (at Southern Cross University) and Torrens University Australia are embarking on a ground-breaking study to generate this much-needed evidence. The 6-month clinical study will explore whether OLE is safe and effective at improving blood glucose control, diabetes-related distress and quality of life, in adults living with type 2 diabetes. If OLE is shown to be a suitable treatment for diabetes, it may help support individuals living with the condition to reach their blood glucose targets, and in turn, help reduce the impact of diabetes on their lives.
Interventions
Olive leaf extract (733.34 mg; equivalent to 3.3 g of fresh Olea europaea leaf, standardised to 55 mg oleuropein; plus excipients), 2 capsules once daily after breakfast, for 24 weeks. Treatment adherence will be monitored using a self-reported administration record, and returned capsule count.
Sponsors
National Centre for Naturopathic Medicine, Southern Cross University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of Type 2 Diabetes Mellitus (as diagnosed by a medical doctor or nurse) 2. Diabetes of at least 12 months duration, 3. Not receiving insulin therapy, 4. Not received OLE within the previous 6 months, 5. Able to provide written consent, 6. Fluent in written and spoken English, and 7. Aged 18 years or older.
Exclusion criteria
1. History of any condition causing moderate to severe cognitive impairment (e.g. dementia, acquired brain injury), 2. Known allergy to olives or olive leaf, 3. Needle phobia or strong aversion to providing a blood sample, 4. Known pregnancy and/or actively breastfeeding, or 5. Participated in a clinical trial within the past 30 days.
Outcome results
None listed