Prevention With Oleanolic Acid of Insulin Resistance (PREOLIA)

Prevention With Oleanolic Acid of Insulin Resistance and Metabolic Syndrome in Adolescents

Oleanolic acid (OA), a triterpene that is highly present in olive leaves, has been proposed as component of functional foods in the prevention of metabolic syndrome due to its anti-inflammatory activity. In this research project we will study the presence of OA in postprandial TRL in healthy adolescents and in normal weight. Moreover, THP-1 macrophages will be incubated with LPS for 48h after pretreatment with OA at different concentrations. Also, TRL will be isolated from healthy adolescents before and 2 and 5h postprandially after the intake of a meal containing the functional olive oil or common olive oil and incubated with THP-1 macrophages.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Insulin Resistance
• Intervention / Treatment: Other: Functional olive oil; Other: Olive oil

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 18016
    • Faculty of Health Sciences (University of Granada)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

-Participants without digestive, metabolic or oncologic disorders or any other pathology

Exclusion Criteria:

-Not having the informed consent signed by the parents

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OA-enriched functional olive oil	Other: Functional olive oil; Eleven adolescents will consume OA-enriched functional olive oil. After eating the olive oil, aliquots of cubital blood will be drawn at 2 and 5 hours of the postprandial period. During that time, free access to water intake will be allowed.
Active Comparator: Olive oil not enriched in OA	Other: Olive oil; Eleven adolescents will consume olive oil. After eating the olive oil, aliquots of cubital blood will be drawn at 2 and 5 hours of the postprandial period. During that time, free access to water intake will be allowed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pro-inflammatory cytokines	The pro-inflammatory cytokines were studied in THP-1 macrophages stimulated with postprandial triglyceride-rich lipoproteins	One year

Collaborators and Investigators

• Sponsor: Universidad de Granada

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): September 14, 2020
• Study Completion (Actual): July 30, 2021

Study Registration Dates

• First Submitted: September 10, 2021
• First Submitted That Met QC Criteria: September 10, 2021
• First Posted (Actual): September 20, 2021

Study Record Updates

• Last Update Posted (Actual): September 20, 2021
• Last Update Submitted That Met QC Criteria: September 10, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Hyperinsulinism; Syndrome; Metabolic Syndrome; Insulin Resistance
• Other Study ID Numbers: B-AGR-287-UGR18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No