Complement Ther Clin Pract. 2025 Jan 13;59:101949. doi: 10.1016/j.ctcp.2025.101949. Online ahead of print.
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).
PMID:39818111 | DOI:10.1016/j.ctcp.2025.101949
