Prevention With Oleanolic Acid of Insulin Resistance

NCT05049304 | Completed DMC

• 1 other identifier: B-AGR-287-UGR18
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insulin Resistance; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Pro-inflammatory cytokines

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

  One year

Study Arms (2)

OA-enriched functional olive oil

EXPERIMENTAL

Other: Functional olive oil

Olive oil not enriched in OA

ACTIVE COMPARATOR

Other: Olive oil

Interventions

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.

OA-enriched functional olive oil

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.

Olive oil not enriched in OA

Eligibility Criteria

• Age: 16 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Not having the informed consent signed by the parents

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Faculty of Health Sciences (University of Granada)

Granada, 18016, Spain

Location

MeSH Terms

Conditions

Insulin Resistance; Metabolic Syndrome

Interventions

Olive Oil

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 20, 2021
• Study Start: January 1, 2020
• Primary Completion: September 14, 2020
• Study Completion: July 30, 2021
• Last Updated: September 20, 2021

Record last verified: 2021-09

Locations

ES (1)