Prevention With Oleanolic Acid of Insulin Resistance

NCT ID: NCT05049304

Last Updated: 2021-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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Insulin Resistance Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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OA-enriched functional olive oil

Group Type EXPERIMENTAL

Functional olive oil

Intervention Type OTHER

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.

Olive oil not enriched in OA

Group Type ACTIVE_COMPARATOR

Olive oil

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

-Not having the informed consent signed by the parents
Minimum Eligible Age

16 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de Granada

OTHER

Sponsor Role lead

Responsible Party

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Emilio Gonzalez Jimenez

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Health Sciences (University of Granada)

Granada, , Spain

Site Status

Countries

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Spain

Other Identifiers

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B-AGR-287-UGR18

Identifier Type: -

Identifier Source: org_study_id

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