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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]

None

Universal Trial Number (UTN)

Trial acronym

ESOLED

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Type 2 Diabetes Mellitus

Condition category

Condition code

Metabolic and Endocrine

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]

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]

Change in Glycosylated Haemoglobin (HbA1c; %; measured using High-Performance Liquid Chromatography from a venous blood sample )

Timepoint [1]

Weeks 0 (baseline), 12 (mid-intervention) and 24 (post-intervention; primary timepoint).

Secondary outcome [1]

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]

Weeks 0 (baseline), 12 (mid-intervention) and 24 (post-intervention).

Secondary outcome [2]

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]

Weeks 0 (baseline), 12 (mid-intervention) and 24 (post-intervention).

Secondary outcome [3]

Change in Diabetes-Related Distress (measured using the 17-item Diabetes Distress Scale)

Timepoint [3]

Weeks 0 (baseline), 12 (mid-intervention) and 24 (post-intervention).

Secondary outcome [4]

Change in Health-Related Quality of Life (measured using the Assessment of Quality of Life 8-dimension instrument)

Timepoint [4]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2480 - Lismore

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Olive Wellness Institute

Address [1]

151 Broderick Road Lara VIC 3212

Country [1]

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]

None

Name [1]

N/A

Address [1]

N/A

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Cross University Human Research Ethics Committee

Ethics committee address [1]

Southern Cross University
PO Box 157
Lismore NSW 2480

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/03/2022

Approval date [1]

12/04/2022

Ethics approval number [1]

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

A/Prof Matthew Leach

Address

National Centre for Naturopathic Medicine Southern Cross University Military Road Lismore, NSW, 2480

Country

Australia

Phone

+61 2 6620 3298

Fax

[email protected]

Contact person for public queries

Name

Matthew Leach

Address

National Centre for Naturopathic Medicine Southern Cross University Military Road Lismore, NSW, 2480

Country

Australia

Phone

+61 2 6620 3298

Fax

[email protected]

Contact person for scientific queries

Name

Matthew Leach

Address

National Centre for Naturopathic Medicine Southern Cross University Military Road Lismore, NSW, 2480

Country

Australia

Phone

+61 2 6620 3298

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• The study dataset only will be available to researchers upon reasonable request.

Conditions for requesting access:
• -

What individual participant data might be shared?

• The dataset will contain participant outcome data. No individually identifiable information will be shared.

What types of analyses could be done with individual participant data?

• Original meta-analyses

When can requests for individual participant data be made (start and end dates)?

From:
Start date: Early 2025
End date: 5 years after publication

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• A reasonable request for data must be made in writing to the Principal Investigator (email: [email protected]).

Are there extra considerations when requesting access to individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically