Oleanolic Acid as Therapeutic Adjuvant for Type 2 Diabetes Mellitus (OLTRAD STUDY)

Oleanolic acid (OA), is a natural component of many plant food and medicinal herbs, which has shown to exert in experimental models hypoglycemic and hypolipidemic effects, and also a cytoprotective action against oxidative and chemotoxic stress underlying Type II Diabetes Mellitus (T2DM).Today it is known that OA shares mechanisms of action with metformin and other drugs of choice for the treatment of diabetes. Therefore, the OLTRAD (OLeanolic acid TReAtment for type 2 Diabetes) Study, a prospective, parallel group, randomized, double-blind, controlled trial with 100 participants, has been designed to demonstrate that the regular intake of an OA-enriched functional olive oil is effective as an adjuvant to metformin antidiabetic drug therapy. The hypothesis is that the inclusion of this functional olive oil in the diet will enhance the effects of the pharmacological treatment in diabetic patients, and may even reduce the need for prescription of such medications.

NCT Number	NCT06030544
Lead Sponsor	Spanish National Research Council Collaborators: Andalusian Health Service, Universidad Pablo de Olavide
Conditions	Diabetic Patients, Type II Diabetes Mellitus
Enrollment	100 participants
Start Date	2022-02-25
Primary Completion	2025-03-20 (estimated)
Study Completion	2025-06-30 (estimated)
Updated on ClinicalTrials.gov	2025-03-07