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NCT05049304 Clinical Trial

Prevention With Oleanolic Acid of Insulin Resistance

Metabolic Syndrome Clinical Trial

— PREOLIA  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05049304
Other study ID # B-AGR-287-UGR18
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2020
Est. completion date July 30, 2021

Study information
Verified date September 2021
Source Universidad de Granada
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date July 30, 2021
Est. primary completion date September 14, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 17 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.
• 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.

Locations
Country Name City State
Spain Faculty of Health Sciences (University of Granada) Granada

Sponsors (1)
Lead Sponsor Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

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