Efficacy and safety of olive leaf extract (Olea europaea L.) for glycaemic control in adults with type 2 diabetes mellitus (ESOLED): A pilot randomised controlled trial.

Leach, MJ; Breakspear, I

Efficacy and safety of olive leaf extract (Olea europaea L.) for glycaemic control in adults with type 2 diabetes mellitus (ESOLED): A pilot randomised controlled trial.

Leach, MJ Breakspear, I

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Publisher:: ELSEVIER SCI LTD
Publication Type:: Journal Article
Citation:: Complement Ther Clin Pract, 2025, 59, pp. 101949
Issue Date:: 2025-05

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Field	Value	Language
dc.contributor.author	Leach, MJ
dc.contributor.author	Breakspear, I https://orcid.org/0000-0002-6525-4728
dc.date.accessioned	2025-07-16T23:15:30Z
dc.date.available	2025-01-12
dc.date.available	2025-07-16T23:15:30Z
dc.date.issued	2025-05
dc.identifier.citation	Complement Ther Clin Pract, 2025, 59, pp. 101949
dc.identifier.issn	1744-3881
dc.identifier.issn	1873-6947
dc.identifier.uri	http://hdl.handle.net/10453/188485
dc.description.abstract	BACKGROUND: Maintaining optimum glycaemic control is essential to reducing comorbidity and mortality in diabetes. However, research indicates that <50 % of patients achieve their target HbA1c ranges. Laboratory studies suggest that olive leaf extract (OLE) may improve glycaemic control, however clinical studies in persons with diabetes are lacking. METHODS: ESOLED is a pilot, randomised, placebo-controlled trial. Adults with a diagnosis of type 2 diabetes of ≥12 months duration, and not receiving insulin therapy, were eligible to participate. Participants were randomised to receive OLE or placebo capsules for 24 weeks. The primary outcome was change in HbA1c. Secondary outcomes included changes in the homeostasis model assessment of insulin resistance, diabetes-related stress, health-related quality of life, and safety. RESULTS: Thirty-one participants were randomly assigned to the OLE (n = 16) and placebo (n = 15) groups. Analyses found no statistically significant time-group interactions for HbA1c, diabetes-related distress or health-related quality of life. Although participants receiving OLE demonstrated greater improvements in insulin sensitivity than those on placebo, there was no significant difference between groups over time. OLE and placebo were found to be well-tolerated, with no severe or serious adverse events reported in either group. CONCLUSION: The ESOLED trial has provided preliminary evidence on the tolerability of OLE in adults with type 2 diabetes, but was inconclusive in determining whether OLE is effective at improving glycaemic control, insulin sensitivity, diabetes-related distress and quality of life. Larger trials and further exploration of the bioavailability of OLE are needed to fully assess the therapeutic potential of OLE in diabetes. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN12622000616774).
dc.format	Print-Electronic
dc.language	eng
dc.publisher	ELSEVIER SCI LTD
dc.relation.ispartof	Complement Ther Clin Pract
dc.relation.isbasedon	10.1016/j.ctcp.2025.101949
dc.rights	info:eu-repo/semantics/openAccess
dc.subject	1104 Complementary and Alternative Medicine, 1110 Nursing
dc.subject.classification	Complementary & Alternative Medicine
dc.subject.classification	4208 Traditional, complementary and integrative medicine
dc.subject.mesh	Humans
dc.subject.mesh	Diabetes Mellitus, Type 2
dc.subject.mesh	Olea
dc.subject.mesh	Plant Extracts
dc.subject.mesh	Female
dc.subject.mesh	Male
dc.subject.mesh	Middle Aged
dc.subject.mesh	Pilot Projects
dc.subject.mesh	Plant Leaves
dc.subject.mesh	Glycated Hemoglobin
dc.subject.mesh	Aged
dc.subject.mesh	Adult
dc.subject.mesh	Glycemic Control
dc.subject.mesh	Quality of Life
dc.subject.mesh	Blood Glucose
dc.subject.mesh	Hypoglycemic Agents
dc.subject.mesh	Insulin Resistance
dc.subject.mesh	Humans
dc.subject.mesh	Olea
dc.subject.mesh	Plant Leaves
dc.subject.mesh	Diabetes Mellitus, Type 2
dc.subject.mesh	Insulin Resistance
dc.subject.mesh	Blood Glucose
dc.subject.mesh	Plant Extracts
dc.subject.mesh	Hypoglycemic Agents
dc.subject.mesh	Pilot Projects
dc.subject.mesh	Quality of Life
dc.subject.mesh	Adult
dc.subject.mesh	Aged
dc.subject.mesh	Middle Aged
dc.subject.mesh	Female
dc.subject.mesh	Male
dc.subject.mesh	Glycemic Control
dc.subject.mesh	Glycated Hemoglobin
dc.subject.mesh	Humans
dc.subject.mesh	Diabetes Mellitus, Type 2
dc.subject.mesh	Olea
dc.subject.mesh	Plant Extracts
dc.subject.mesh	Female
dc.subject.mesh	Male
dc.subject.mesh	Middle Aged
dc.subject.mesh	Pilot Projects
dc.subject.mesh	Plant Leaves
dc.subject.mesh	Glycated Hemoglobin
dc.subject.mesh	Aged
dc.subject.mesh	Adult
dc.subject.mesh	Glycemic Control
dc.subject.mesh	Quality of Life
dc.subject.mesh	Blood Glucose
dc.subject.mesh	Hypoglycemic Agents
dc.subject.mesh	Insulin Resistance
dc.title	Efficacy and safety of olive leaf extract (Olea europaea L.) for glycaemic control in adults with type 2 diabetes mellitus (ESOLED): A pilot randomised controlled trial.
dc.type	Journal Article
utslib.citation.volume	59
utslib.location.activity	England
utslib.for	1104 Complementary and Alternative Medicine
utslib.for	1110 Nursing
pubs.organisational-group	University of Technology Sydney
pubs.organisational-group	University of Technology Sydney/Faculty of Health
utslib.copyright.status	open_access	*
dc.rights.license	This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0). To view a copy of this license, visit https://creativecommons.org/licenses/by/4.0/
dc.date.updated	2025-07-16T23:15:28Z
pubs.publication-status	Published
pubs.volume	59

Abstract:

BACKGROUND: Maintaining optimum glycaemic control is essential to reducing comorbidity and mortality in diabetes. However, research indicates that <50 % of patients achieve their target HbA1c ranges. Laboratory studies suggest that olive leaf extract (OLE) may improve glycaemic control, however clinical studies in persons with diabetes are lacking. METHODS: ESOLED is a pilot, randomised, placebo-controlled trial. Adults with a diagnosis of type 2 diabetes of ≥12 months duration, and not receiving insulin therapy, were eligible to participate. Participants were randomised to receive OLE or placebo capsules for 24 weeks. The primary outcome was change in HbA1c. Secondary outcomes included changes in the homeostasis model assessment of insulin resistance, diabetes-related stress, health-related quality of life, and safety. RESULTS: Thirty-one participants were randomly assigned to the OLE (n = 16) and placebo (n = 15) groups. Analyses found no statistically significant time-group interactions for HbA1c, diabetes-related distress or health-related quality of life. Although participants receiving OLE demonstrated greater improvements in insulin sensitivity than those on placebo, there was no significant difference between groups over time. OLE and placebo were found to be well-tolerated, with no severe or serious adverse events reported in either group. CONCLUSION: The ESOLED trial has provided preliminary evidence on the tolerability of OLE in adults with type 2 diabetes, but was inconclusive in determining whether OLE is effective at improving glycaemic control, insulin sensitivity, diabetes-related distress and quality of life. Larger trials and further exploration of the bioavailability of OLE are needed to fully assess the therapeutic potential of OLE in diabetes. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN12622000616774).

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