Skip to main content
OpenTrials
Completed

NCT Number: NCT04328571

Effects of Enzymatic Digestion and Probiotic on Oleuropein Bioavailability

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Subjects

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Católica San Antonio

Murcia, 30107, Spain

About this study

Male or female healthy adults between 25 and 65 years of age will be randomized into one of the 3 following groups to receive:

  • Capsule of OLE + 1 stick of maltodextrin
  • Capsule of OLE enzymatically treated + 1 stick of maltodextrin
  • Capsule OLE + 1 stick of probiotic

52 subjects will be randomized to achieve 15 subjects per group to complete the trial.

The study will involve 3 phases:

  • PK1 (all subjects will receive one capsule of OLE in the morning and blood samples will be collected at different timepoints for 24h) followed by a washout period of 1 day
  • 3 weeks intervention (subjects will receive the product thy have benn assigned to) followed by a wash-out period of 3 days
  • PK2 period (subjects will receive one capsule the product thy have benn assigned to

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Receiving or having received antibiotics in the past 4 weeks prior to the day of inclusion
  • 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

Treatment and study plan

OLE enzymatically treated

Dietary Supplement

OLE (Olive leaf extract ) enzymatically treated + maltodextrin

OLE + probiotic

Dietary Supplement

OLE (Olive leaf extract) co-administered with probiotic

OLE

Dietary Supplement

OLE (Olive leaf extract) + maltodextrin

Primary outcomes

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

    Time frame: 24 hours

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

Secondary outcomes

  1. Cmax during PK2 period

    Time frame: 24 hours

    Cmax of total and individual oleuropein metabolites during PK2 period

  2. Tmax during PK2 period

    Time frame: 24 hours

    Tmax of total and individual oleuropein metabolites during PK2 period

  3. T1/2 during PK2 period

    Time frame: 24 hours

    T1/2 of total and individual oleuropein metabolites during PK2 period

  4. Levels of total and individual oleuropein metabolites in urine at PK2

    Time frame: 24 hours

    Levels of total and individual oleuropein metabolites excreted in the urine collected over 24 hours during PK2

  5. AUC0-24h during PK1

    Time frame: 24 hours

    AUC0-24h (concentration/time curve) of individual blood oleuropein metabolites during PK1 period

  6. Cmax during PK1

    Time frame: 24 hours

    Cmax of total and individual blood oleuropein metabolites during PK1 period

  7. Tmax during PK1

    Time frame: 24 hours

    Tmax of total and individual blood oleuropein metabolites during PK1 period

  8. T1/2 during PK1

    Time frame: 24 hours

    T1/2 of total and individual blood oleuropein metabolites during PK1 period

  9. Levels of total and individual oleuropein metabolites in urine at PK1

    Time frame: 24 hours

    Levels of total and individual oleuropein metabolites excreted in the urine collected over 24 hours during PK1

  10. Change in gut microbiota bacterial population diversity

    Time frame: 3 weeks

    Change from baseline to end of the 3-week intervention period of gut microbiota bacterial population diversity (16SrDNA sequencing)

  11. Change in levels of faecal oleuropein metabolites

    Time frame: 3 weeks

    Change from baseline to end of the 3-week intervention period of faecal oleuropein metabolites

Other outcomes

  1. Change of gut microbiota faecal short chain fatty acids

    Time frame: 3 weeks

    Change from baseline to end of the 3-week intervention period of gut microbiota faecal short chain fatty acids (acetate, propionate, butyrate) & lactate

  2. Change of gut microbiota faecal branched chain fatty acids

    Time frame: 3 weeks

    Change from baseline to end of the 3-week intervention period of gut microbiota faecal branched chain fatty acids (isobutyrate, isovalerate & isocaproate)

  3. Change of gut microbiota faecal ammonium production

    Time frame: 3 weeks

    Change from baseline to end of the 3-week intervention period of gut microbiota faecal ammonium production

  4. Blood levels of total cholesterol

    Time frame: 3 weeks

    Change from baseline to the end of the 3-week intervention period of total cholesterol levels

  5. Blood levels of LDL

    Time frame: 3 weeks

    Change from baseline to the end of the 3-week intervention period of LDL levels

  6. Blood levels of HDL

    Time frame: 3 weeks

    Change from baseline to the end of the 3-week intervention period of HDL levels

  7. Blood levels of ALAT

    Time frame: 3 weeks

    Change from baseline to the end of the 3-week intervention period of ALAT levels

  8. Blood levels of ASAT

    Time frame: 3 weeks

    Change from baseline to the end of the 3-week intervention period of ASAT levels

  9. Blood levels of creatinine

    Time frame: 3 weeks

    Change from baseline to the end of the 3-week intervention period of creatinine levels

  10. Blood levels of glucose

    Time frame: 3 weeks

    Change from baseline to the end of the 3-week intervention period of glucose levels

  11. Blood levels of triglycerides

    Time frame: 3 weeks

    Change from baseline to the end of the 3-week intervention period of triglycerides levels

  12. Blood levels of bone biomarkers

    Time frame: 3 weeks

    Change from baseline to the end of the 3-week intervention period of bone biomarkers (P1NP, CTX)

  13. Blood levels of Oxidized LDL

    Time frame: 3 weeks

    Change from baseline to the end of the 3-week intervention period of Oxidized LDL

  14. Levels of biomarkers of oxidative stress

    Time frame: 3 weeks

    8-NO2GU, 8-OH-GU, 8-OH GUO, 8-OH-DGUO, 8 NO2 GUO, cGMP, 8-NO2-cGMP, Prostanoids, Oxylipins, Isoprostanes, Phytoprostanes and Phytofuranes

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 31, 2020
Registry last updated
Oct 1, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.