Bioavailability of Oleanolic Acid Formulated as Functional Olive Oil

Summary

The oral bioavailability of Oleanolic acid (OA) when formulated as functional olive oil, and its mechanisms of systemic transport, will be approached by mean of randomized and controlled trial with 20 healthy volunteers. Ten individuals randomly selected will receive 55 mL of the functional OA-enriched olive oil (equivalent dose 30 mg OA) as part of an experimental breakfast. The other ten participants will receive within this experimental meal the same amount of the control olive oil. Immediately before and after eating the respective breakfasts, aliquots of cubital blood will be drawn every hour, over a postprandial period of 7 hours. Since in this trial design, each participant is his/her own control, a four-week washout period is established, after which a new series of tests that cross the type of olive oil consumed will be carried out.

From the aliquots of cubital blood, sera will be obtained by centrifugation. The extraction and quantification of serum OA will be realized by gas chromatography (GC) using flame ionization (FID) and mass spectrometry (MS) detectors. In the pharmacokinetic analysis of data, a mono-compartmental model will be assumed. It will be determined: 1) absorption parameters such as the maximum concentration achieved and the timing for it, the constant of absorption and the area under the curve; 2) distribution parameters such as the constant and volume of distribution; 3) metabolism parameters, such as the OA fraction associated with albumin; and 4) elimination parameters such as the elimination constant, the half-life and the clearance.

To demonstrate the presence of OA in postprandial TRL, chylomicron and VLDL fractions will be prepared by plasma ultrafiltration in normal saline, and hydrolysed with pancreatic enzyme. The possible presence of OA among the TRL-derived lipids will be evaluated. The content of apo B48 and B100, as markers of the presence of chylomicrons and VLDL, respectively, will be determined by ELISA.

Other parameters related to glycemic control, such as serum insulin, C-peptide and GLP-1 will be analyzed by ELISA.

Conditions

• Healthy Subjects
• Bioavailability

Interventions

DIETARY_SUPPLEMENT

Oleanolic acid (CAS no. 598-02-1; PubChem CID 10494)

Postprandial study of bioavailability of Oleanolic acid, formulated as functional olive oil, in healthy subjects

DIETARY_SUPPLEMENT

Control commercial olive oil

Postprandial study of Oleanolic acid bioavailability in healthy subjects

Sponsors & Collaborators

• Andalusian Health Service

  collaborator OTHER_GOV

• Universidad Pablo de Olavide

  collaborator OTHER

• Spanish National Research Council

  lead OTHER_GOV

Principal Investigators

• José M. Castellano, PhD · Instituto de la Grasa-Spanish National Research Council (CSIC)

• Pedro P. García-Luna · Andalusian Public Foundation for Health Research Management in Seville

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

30 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-03-15

Primary Completion

2021-06-30

Completion

2021-07-15

Countries

• Spain

Study Locations