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OpenTrials
Completed

NCT Number: NCT05049304

Prevention With Oleanolic Acid of Insulin Resistance

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.

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Key information

Conditions

Insulin Resistance Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

16 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Health Sciences (University of Granada)

Granada, 18016, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-Not having the informed consent signed by the parents

Treatment and study plan

Functional olive oil

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

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.

Primary outcomes

  1. Pro-inflammatory cytokines

    Time frame: One year

    The pro-inflammatory cytokines were studied in THP-1 macrophages stimulated with postprandial triglyceride-rich lipoproteins

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study title

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

Acronym: PREOLIA

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Sep 20, 2021
Registry last updated
Sep 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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