Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000616774
Ethics application status
Approved
Date submitted
11/04/2022
Date registered
26/04/2022
Date last updated
18/08/2024
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
Completed
Date of first participant enrolment
Anticipated
9/05/2022
Actual
23/02/2023
Date of last participant enrolment
Anticipated
17/06/2022
Actual
16/01/2024
Date of last data collection
Anticipated
2/12/2022
Actual
19/07/2024
Sample size
Target
40
Accrual to date
Final
31
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
Approved
Ethics committee name [1] 310736 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [1] 310736 0
Ethics committee country [1] 310736 0
Australia
Date submitted for ethics approval [1] 310736 0
17/03/2022
Approval date [1] 310736 0
12/04/2022
Ethics approval number [1] 310736 0

Summary
Brief summary
Trial website
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
[email protected]
Contact person for public queries
Name 118687 0
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
[email protected]
Contact person for scientific queries
Name 118688 0
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
[email protected]

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: Early 2025
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: [email protected]).


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.