NCT04328571

Brief Summary

This is a 3-arms randomized-controlled, parallel group, single center, double-blind study investigating the bioavailability of olive oil extract (OLE) in two different OLE formulations (enzymatically treated and co-administered with a probiotic) compared to original OLE formulation in healthy adult subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2020

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2020

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 31, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
Last Updated

October 1, 2021

Status Verified

September 1, 2021

Enrollment Period

1.3 years

First QC Date

March 5, 2020

Last Update Submit

September 30, 2021

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • AUC0-24h of individual blood oleuropein metabolites during PK2 period

    AUC0-24h (concentration/time curve) of individual blood oleuropein metabolites during PK2 period

    24 hours

Secondary Outcomes (11)

  • Cmax during PK2 period

    24 hours

  • Tmax during PK2 period

    24 hours

  • T1/2 during PK2 period

    24 hours

  • Levels of total and individual oleuropein metabolites in urine at PK2

    24 hours

  • AUC0-24h during PK1

    24 hours

  • +6 more secondary outcomes

Other Outcomes (14)

  • Change of gut microbiota faecal short chain fatty acids

    3 weeks

  • Change of gut microbiota faecal branched chain fatty acids

    3 weeks

  • Change of gut microbiota faecal ammonium production

    3 weeks

  • +11 more other outcomes

Study Arms (3)

OLE enzymatically treated

EXPERIMENTAL

Participants will receive 1 capsule of OLE enzymatically treated + 1 stick of maltodextrin each day in the morning for 21 days

Dietary Supplement: OLE enzymatically treated

OLE + probiotic

EXPERIMENTAL

Participants will receive 1 capsule of OLE + 1 stick of probiotic each day in the morning for 21 days

Dietary Supplement: OLE + probiotic

OLE

ACTIVE COMPARATOR

Participants will receive 1 capsule of OLE + 1 stick of maltodextrin each day in the morning for 21 days

Dietary Supplement: OLE

Interventions

OLE enzymatically treatedDIETARY_SUPPLEMENT

OLE (Olive leaf extract ) enzymatically treated + maltodextrin

OLE enzymatically treated
OLE + probioticDIETARY_SUPPLEMENT

OLE (Olive leaf extract) co-administered with probiotic

OLE + probiotic
OLEDIETARY_SUPPLEMENT

OLE (Olive leaf extract) + maltodextrin

OLE

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willing and able to sign written informed consent prior to trial entry
  • Male or female healthy adults between 25 and 65 years of age
  • Body Mass Index (BMI) within the range 18.5 - 29.9 (both inclusive)
  • In good health as determined by medical judgment and medical history

You may not qualify if:

  • Any food allergy/intolerance
  • Subjects not willing and/or not able to comply with scheduled visits and the requirements of the study protocol
  • Taking or anticipated initiation of any lipid-modifying or blood-clotting medication e.g. statins, cholesterol lowering
  • Smokers
  • Alcohol intake higher than 2 servings per day (one serving is 0.4 dL of strong alcohol, 1 dL of wine, or 3 dL of beer) or drug abuse
  • Overly imbalanced or restrictive diet (e.g. hyperproteic, vegan, ketogenic, etc.)
  • Hormonal treatment for women linked to menopause (contraceptive treatment accepted)
  • Pregnancy or breastfeeding
  • Supplements or foods containing probiotics (yogurts allowed)
  • Currently participating or having participated in another clinical trial within 4 weeks prior to trial start

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Católica San Antonio

Murcia, 30107, Spain

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Francisco A. Tomás-Barberán, Prof.

    CEBAS-CSIC, Murcia, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Single coding
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 3-arms randomized-controlled, parallel group, single center, double-blinded study investigating 3 different formulations of the investigational product
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2020

First Posted

March 31, 2020

Study Start

February 10, 2020

Primary Completion

May 15, 2021

Study Completion

September 15, 2021

Last Updated

October 1, 2021

Record last verified: 2021-09

Locations

ES(1)