Efficacy and Safety of Olive Leaf Extract for Diabetes (ESOLED)

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12622000616774
• Lead Sponsor: ational Centre for Naturopathic Medicine, Southern Cross University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-26
• Study Completion: 2024-07-19
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 31

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Glycosylated Haemoglobin (HbA1c; %; measured using High-Performance Liquid Chromatography from a venous blood sample )[ Weeks 0 (baseline), 12 (mid-intervention) and 24 (post-intervention; primary timepoint).]

Secondary Outcome Measures

Name	Time	Method
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)[ Weeks 0 (baseline), 12 (mid-intervention) and 24 (post-intervention).];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)[ Weeks 0 (baseline), 12 (mid-intervention) and 24 (post-intervention).];Change in Diabetes-Related Distress (measured using the 17-item Diabetes Distress Scale) [ Weeks 0 (baseline), 12 (mid-intervention) and 24 (post-intervention).];Change in Health-Related Quality of Life (measured using the Assessment of Quality of Life 8-dimension instrument)[ Weeks 0 (baseline), 12 (mid-intervention) and 24 (post-intervention).]