Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000616774p
Ethics application status
Submitted, not yet approved
Date submitted
11/04/2022
Date registered
26/04/2022
Date last updated
26/04/2022
Date data sharing statement initially provided
26/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy and Safety of Olive Leaf Extract for Diabetes (ESOLED)
Scientific title
Efficacy and safety of olive leaf extract for glycaemic control in adults with type 2 diabetes mellitus (ESOLED): a pilot randomised controlled trial
Secondary ID [1] 306893 0
None
Universal Trial Number (UTN)
Trial acronym
ESOLED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 325991 0
Condition category
Condition code
Metabolic and Endocrine 323305 323305 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 323346 0
Treatment: Other
Comparator / control treatment
Placebo (excipients only, including microcellulose and colloidal anhydrous silica), 2 capsules once daily after breakfast, for 24 weeks. Capsules will match in colour, consistency and appearance to the OLE capsules.
Control group
Placebo

Outcomes
Primary outcome [1] 331040 0
Change in Glycosylated Haemoglobin (HbA1c; %; measured using High-Performance Liquid Chromatography from a venous blood sample )
Timepoint [1] 331040 0
Weeks 0 (baseline), 12 (mid-intervention) and 24 (post-intervention; primary timepoint).
Secondary outcome [1] 408568 0
Change in Insulin resistance (assessed using the homeostasis model assessment of insulin resistance, which is calculated using fasting plasma insulin and glucose concentrations from a venous blood sample)
Timepoint [1] 408568 0
Weeks 0 (baseline), 12 (mid-intervention) and 24 (post-intervention).
Secondary outcome [2] 408569 0
Safety (i.e. adverse effects, such as stomach ache, headache, cough, vertigo, elevated serum creatinine, or elevated liver enzymes; as measured using a self-reported adverse event record, and venous blood samples)
Timepoint [2] 408569 0
Weeks 0 (baseline), 12 (mid-intervention) and 24 (post-intervention).
Secondary outcome [3] 408570 0
Change in Diabetes-Related Distress (measured using the 17-item Diabetes Distress Scale)
Timepoint [3] 408570 0
Weeks 0 (baseline), 12 (mid-intervention) and 24 (post-intervention).
Secondary outcome [4] 408571 0
Change in Health-Related Quality of Life (measured using the Assessment of Quality of Life 8-dimension instrument)
Timepoint [4] 408571 0
Weeks 0 (baseline), 12 (mid-intervention) and 24 (post-intervention).

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation codes will be held in sequentially-numbered opaque sealed envelopes, and each envelope selected in consecutive order at the time of participant enrolment. This process will be undertaken by a third party not directly involved in the administration of the study. Block sizes will not be disclosed to the third party to ensure allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation will be used with computer-generated randomly permuted blocks of random sizes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
SAMPLE SIZE: Based on the flat rule-of-thumb for two-armed pilot trials (accounting for 90% power, moderate effect size and 15% attrition), a sample size of 40 participants (20 per arm) will be required (Whitehead et al 2016).

DATA ANALYSIS: Data will be analysed by intention-to-treat using SPSS (v.26). A per-protocol analysis will be conducted for hypothesis-generating purposes only. Missing data will be handled using the multiple imputation method. Baseline differences between groups will be examined using the t-test for independent groups or Chi-square tests. Differences in study outcomes between groups, across all timepoints, will be examined using linear mixed-effects models.. The level of statistical significance will be set at p<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/05/2022
Actual
Date of last participant enrolment
Anticipated
17/06/2022
Actual
Date of last data collection
Anticipated
2/12/2022
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 37335 0
2480 - Lismore

Funding & Sponsors
Funding source category [1] 311207 0
Other Collaborative groups
Name [1] 311207 0
Olive Wellness Institute
Country [1] 311207 0
Australia
Primary sponsor type
University
Name
National Centre for Naturopathic Medicine, Southern Cross University
Address
Military Road
East Lismore, NSW, 2480
Country
Australia
Secondary sponsor category [1] 312578 0
None
Name [1] 312578 0
N/A
Address [1] 312578 0
N/A
Country [1] 312578 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310736 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [1] 310736 0
Southern Cross University
PO Box 157
Lismore NSW 2480
Ethics committee country [1] 310736 0
Australia
Date submitted for ethics approval [1] 310736 0
17/03/2022
Approval date [1] 310736 0
Ethics approval number [1] 310736 0

Summary
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.
Trial website
https://www.facebook.com/profile.php?id=100078714130543
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118686 0
A/Prof Matthew Leach
Address 118686 0
National Centre for Naturopathic Medicine
Southern Cross University
Military Road
Lismore, NSW, 2480
Country 118686 0
Australia
Phone 118686 0
+61 2 6620 3298
Fax 118686 0
Email 118686 0
matthew.leach@scu.edu.au
Contact person for public queries
Name 118687 0
A/Prof Matthew Leach
Address 118687 0
National Centre for Naturopathic Medicine
Southern Cross University
Military Road
Lismore, NSW, 2480
Country 118687 0
Australia
Phone 118687 0
+61 2 6620 3298
Fax 118687 0
Email 118687 0
matthew.leach@scu.edu.au
Contact person for scientific queries
Name 118688 0
A/Prof Matthew Leach
Address 118688 0
National Centre for Naturopathic Medicine
Southern Cross University
Military Road
Lismore, NSW, 2480
Country 118688 0
Australia
Phone 118688 0
+61 2 6620 3298
Fax 118688 0
Email 118688 0
matthew.leach@scu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The dataset will contain participant outcome data. No individually identifiable information will be shared.
When will data be available (start and end dates)?
Start date: Mid 2023
End date: 5 years after publication
Available to whom?
The study dataset only will be available to researchers upon reasonable request.
Available for what types of analyses?
Original meta-analyses
How or where can data be obtained?
A reasonable request for data must be made in writing to the Principal Investigator (email: matthew.leach@scu.edu.au).


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.