Back to resultsPrevention With Oleanolic Acid of Insulin Resistance (PREOLIA)
Primary Purpose
Insulin Resistance, Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Functional olive oil
Olive oil
Sponsored by
About this trial
This is an interventional prevention trial for Insulin Resistance
Eligibility Criteria
Inclusion Criteria:
-Participants without digestive, metabolic or oncologic disorders or any other pathology
Exclusion Criteria:
-Not having the informed consent signed by the parents
Sites / Locations
- Faculty of Health Sciences (University of Granada)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
OA-enriched functional olive oil
Olive oil not enriched in OA
Arm Description
Outcomes
Primary Outcome Measures
Pro-inflammatory cytokines
The pro-inflammatory cytokines were studied in THP-1 macrophages stimulated with postprandial triglyceride-rich lipoproteins
Secondary Outcome Measures
Full Information
NCT ID
NCT05049304
First Posted
September 10, 2021
Last Updated
September 10, 2021
Sponsor
Universidad de Granada
1. Study Identification
Unique Protocol Identification Number
NCT05049304
Brief Title
Prevention With Oleanolic Acid of Insulin Resistance
Acronym
PREOLIA
Official Title
Prevention With Oleanolic Acid of Insulin Resistance and Metabolic Syndrome in Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
September 14, 2020 (Actual)
Study Completion Date
July 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Metabolic Syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OA-enriched functional olive oil
Arm Type
Experimental
Arm Title
Olive oil not enriched in OA
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Functional olive oil
Intervention Description
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
Intervention Name(s)
Olive oil
Intervention Description
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 Outcome Measure Information:
Title
Pro-inflammatory cytokines
Description
The pro-inflammatory cytokines were studied in THP-1 macrophages stimulated with postprandial triglyceride-rich lipoproteins
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
-Participants without digestive, metabolic or oncologic disorders or any other pathology
Exclusion Criteria:
-Not having the informed consent signed by the parents
Facility Information:
Facility Name
Faculty of Health Sciences (University of Granada)
City
Granada
ZIP/Postal Code
18016
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Prevention With Oleanolic Acid of Insulin Resistance
We'll reach out to this number within 24 hrs