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ACTIVE NOT RECRUITING
NCT06030544
PHASE2

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

Sponsor: Spanish National Research Council

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2022-02-25

Completion Date

2025-06-30

Last Updated

2025-03-07

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

OA-enriched functional olive oil

Dietary intervention in diabetic patients. Oral intake of 55 mL/day of a functional olive oil enriched in Oleanolic acid (equivalent dose 30 mg/day OA) Oleanolic acid (CAS no. 598-02-1; PubChem CID 10494).

DIETARY_SUPPLEMENT

commercial olive oil

Dietary intervention in diabetic patients. Oral intake of 55 mL/day of a commercial olive oil (blend of virgin and refined olive oils) chosen by its very low content of bioactive minor components.

Locations (1)

Virgen del Rocío University Hospital

Seville, Andalicía, Spain