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Nutritional Intervention With Table Olives in Healthy Volunteers (BIOLIVA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03886597
Recruitment Status : Completed
First Posted : March 22, 2019
Last Update Posted : August 8, 2019
Sponsor:
Collaborators:
Ministerio de Economía y Competitividad (Spain) AGL 2013-41188R
University of Barcelona
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary:
Olives and olive oil are typical components of the Mediterranean diet being part of its cultural and gastronomic heritage. Since ancient times, olives have been used either for both, oil extraction or whole fruit consumption as table olives. Olive oil stands out from both the nutritional and the health point of view. However, the effect of table olives consumption remains almost unknown. The beneficial properties of olive oil have been initially ascribed to the high concentration of oleic acid. Nowadays, these positive effects have been attributed also to minor compounds such as polyphenols or pentacyclic triterpenes. Table olives contain a higher amount of both polyphenols and pentacyclic triterpenes than their oil, with the same healthy fatty acid profile. Therefore, the present intervention aims at investigating the pharmacokinetic of polyphenols and pentacyclic triterpenes after a single olive intake as well as the assessment of the effect of the consumption of olives during 30 days on the overall health status playing particular attention to the anti-inflammatory, antioxidant and cardiovascular biomarkers.

Condition or disease Intervention/treatment Phase
Healthy Biological Availability Nutritional Intervention Functional Food Nutrition Physiology Other: Table Olives Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This study involve two stages, the first one corresponding to the pharmacokinetic study of the single administration of table olives in healthy male volunteers and the second one corresponding to the study of a nutritional intervention with 30 table olives during 30 days.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Table Olives Nutritional Intervention: Pharmacokinetics of Polyphenols and Pentacyclic Triterpenes and Assessment of Antioxidant, Cardiovascular and Anti-inflammatory Biomarkers
Actual Study Start Date : March 25, 2019
Actual Primary Completion Date : May 25, 2019
Actual Study Completion Date : June 15, 2019

Arm Intervention/treatment
Experimental: 60 Arbequina Table Olives
Pharmacokinetics Study
Other: Table Olives
At early morning (08:00 h e.g.) and after 10 hours of fasting conditions, the olives of the Arbequina variety will be administered to each subject. The 60 olives will be weighted before the ingestion and the remaining stones will be subsequently weighted to keep a record of the amount of olive pulp that has been consumed. The subjects will have a period of 5 minutes to ingest 60 olives with 240 mL of water. Blood samples will be collected from 1 hour prior to administration until 24 hours after dosing. Urine samples will also be collected and blood pressure will be measured.

Experimental: 120 Arbequina Table Olives
Pharmacokinetics Study
Other: Table Olives
At early morning (08:00 h e.g.) and after 10 hours of fasting conditions, the olives of the Arbequina variety will be administered to each subject. The 120 olives will be weighted before the ingestion and the remaining stones will be subsequently weighted to keep a record of the amount of olive pulp that has been consumed. The subjects will have a period of 10 minutes to ingest 120 olives with 240 mL of water. Blood samples will be collected from 1 hour prior to administration until 24 hours after dosing. Urine samples will also be collected and blood pressure will be measured.

Experimental: 60 Table Olives
Table Olives Nutritional Intervention
Other: Table Olives
All the subjects will perform two experimental sessions of 30 days with 15 days of washout periods within experimental periods. In one experimental session subjects will ingest table olives and in the other session they will act as their own controls following their normal dietary habits. During all the experiment participants will avoid the consumption of products rich in phenolic and triterpenic compounds. Subjects will include the dose of 60 table olives within their normal dietary habits. Consequently, the olives will be consumed two times daily within each main meal; 30 olives before lunch and 30 olives before dinner. Blood samples will be collected at baseline and 15 and 30 days of each experimental session. Tolerability variables and blood pressure will also be measured.

No Intervention: Control
Control of Table Olives Nutritional Intervention



Primary Outcome Measures :
  1. Stage 1: Maximum plasma concentration (Cmax) [ Time Frame: 24 hours ]
    24 hour dosing period; 2 dosing periods each separated by 7 days washout

  2. Stage 1: Concentration at the end of the dosing interval (Ct) [ Time Frame: 24 hours ]
    24 hour dosing period; 2 dosing periods each separated by 7 days washout

  3. Stage 1: Time until Cmax is reached (Tmax) [ Time Frame: 24 hours ]
    24 hour dosing period; 2 dosing periods each separated by 7 days washout

  4. Stage 1: Area under the curve from administration to last observed concentration at time (AUC (0-t) [ Time Frame: 24 hours ]
    24 hour dosing period; 2 dosing periods each separated by 7 days washout

  5. Stage 1: AUC extrapolated to infinite time (AUC (0-∞) [ Time Frame: 24 hours ]
    24 hour dosing period; 2 dosing periods each separated by 7 days washout

  6. Stage 1: Percentage of AUC extrapolated (AUC%) [ Time Frame: 24 hours ]
    24 hour dosing period; 2 dosing periods each separated by 7 days washout

  7. Stage 1: Terminal elimination rate constant (Kel) [ Time Frame: 24 hours ]
    24 hour dosing period; 2 dosing periods each separated by 7 days washout

  8. Stage 1: Plasma concentration half-life (t ½) [ Time Frame: 24 hours ]
    24 hour dosing period; 2 dosing periods each separated by 7 days washout

  9. Stage 1: Volume of distribution (Vd/ F) [ Time Frame: 24 hours ]
    24 hour dosing period; 2 dosing periods each separated by 7 days washout

  10. Stage 1: Clearance (Cl/F) [ Time Frame: 24 hours ]
    24 hour dosing period; 2 dosing periods each separated by 7 days washout

  11. Stage 1: Peak trough fluctuation over one dosing interval at steady state (PTF) [ Time Frame: 24 hours ]
    24 hour dosing period; 2 dosing periods each separated by 7 days washout

  12. Stage 1: Cmax dose normalized (Cmax/Dose) [ Time Frame: 24 hours ]
    24 hour dosing period; 2 dosing periods each separated by 7 days washout

  13. Stage 1: AUC (0-t) dose normalized (AUC (0-t)/Dose) [ Time Frame: 24 hours ]
    24 hour dosing period; 2 dosing periods each separated by 7 days washout

  14. Stage 1: Urine polyphenols concentration [ Time Frame: 24 hours ]
    24 hour dosing period; 2 dosing periods each separated by 7 days washout

  15. Stage 1: Urine triterpenes concentration [ Time Frame: 24 hours ]
    24 hour dosing period; 2 dosing periods each separated by 7 days washout

  16. Stage 2: Plasma polyphenols concentration [ Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    30 days

  17. Stage 2: Plasma triterpenes concentration [ Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    30 days

  18. Stage 2: Urine polyphenols concentration [ Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    30 days

  19. Stage 2: Urine triterpenes concentration [ Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    30 days

  20. Stage 2: Malondialdehyde concentration [ Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    30 days

  21. Stage 2: Catalase concentration [ Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    30 days

  22. Stage 2: Glutathione peroxidase concentration [ Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    30 days

  23. Stage 2: Superoxide dismutase concentration [ Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    30 days

  24. Stage 2: F2A isoprostane concentration [ Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    30 days

  25. Stage 2: 8 isoprostane concentration [ Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    30 days

  26. Stage 2: Oxidized low-density lipoprotein concentration [ Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    30 days

  27. Stage 2: C-Reactive Protein concentration [ Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    30 days

  28. Stage 2: Lipoprotein-associated phospholipase A2 concentration [ Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    30 days

  29. Stage 2: Apolipoprotein A1 concentration [ Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    30 days

  30. Stage 2: Apolipoprotein B100 concentration [ Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    30 days

  31. Stage 2: Tumor necrosis factor alpha concentration [ Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    30 days

  32. Stage 2: Interleukin 6 concentration [ Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    30 days

  33. Stage 2: Interleukin 1 concentration [ Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    30 days


Secondary Outcome Measures :
  1. Stage 1 and 2: Number of participants with treatment-related adverse events [ Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    30 days

  2. Stage 1 and 2: Systolic and diastolic blood pressure [ Time Frame: Stage 1: 24 hour dosing period; 2 dosing periods each separated by 7 days washout, Stage 2: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    Stage 1: 24 hours, Stage 2: 30 days

  3. Stage 1 and 2: Heart rate [ Time Frame: Stage 1: 24 hour dosing period; 2 dosing periods each separated by 7 days washout, Stage 2: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    Stage 1: 24 hours, Stage 2: 30 days

  4. Stage 1 and 2: Respiratory rate [ Time Frame: Stage 1: 24 hour dosing period; 2 dosing periods each separated by 7 days washout, Stage 2: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    Stage 1: 24 hours, Stage 2: 30 days

  5. Stage 2: Body weight [ Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    30 days

  6. Stage 2: High-density lipoprotein cholesterol concentration (HDL-C) [ Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    30 days

  7. Stage 2: Low-density lipoprotein cholesterol concentration (LDL-C) [ Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    30 days

  8. Stage 2: Very low-density lipoprotein cholesterol concentration (VLDL-C) [ Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    30 days

  9. Stage 2: Triglyceride concentration [ Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    30 days

  10. Stage 2: Total cholesterol concentration [ Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    30 days

  11. Stage 2: Sodium concentration [ Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    30 days

  12. Stage 2: Glucose concentration [ Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    30 days

  13. Stage 2: Urea concentration [ Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    30 days

  14. Stage 2: Creatinine concentration [ Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    30 days

  15. Stage 2: Aspartate aminotransferase concentration [ Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    30 days

  16. Stage 2: Alanine aminotransferase concentration [ Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    30 days

  17. Stage 2: Alkaline phosphatase concentration [ Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    30 days

  18. Stage 2: Total proteins concentration [ Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout ]
    30 days



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body Mass Index between 19 and 30 kg/m2.
  • Healthy on the basis of physical examination and routine biochemical and hematological laboratory determinations.
  • Free acceptance to participate in the study by obtains signed informed consent.

Exclusion Criteria:

  • Smoking.
  • Alcohol or drug abuse.
  • Heavy consumer of stimulating beverages (>5 coffees, teas, chocolate or cola drinks per day) and grapefruit juice.
  • Background of allergy, idiosyncrasy or hypersensitivity to drugs.
  • Intake of any medication within 2 weeks prior taking the study intervention (except for use of paracetamol in short-term symptomatic treatments), including over-the-counter products (including natural food supplements, vitamins and medicinal plants products), or any enzymatic inductor or inhibitor within 3 months before the drug administration.
  • Positive serology for hepatitis B, C or HIV.
  • Background or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematological or neurological disease or other chronic diseases.
  • Having undergone major surgery during the previous 6 months.
  • Pregnancy or lactation status (if applied).
  • Participation in another clinical trial during the 3 months preceding the drug administration.
  • Donation of blood during the 4 weeks preceding the drug administration.
  • Acute illness four weeks before drug administration.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03886597


Locations
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Spain
Institut de Recerca Hospital de la Santa Creu i Sant Pau - CIM Sant Pau
Barcelona, Spain, 08041
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Ministerio de Economía y Competitividad (Spain) AGL 2013-41188R
University of Barcelona
Investigators
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Study Director: Joana M Planas, PhD Prof. Departament de Bioquímica i Fisiologia. Facultat de Farmàcia i Ciències de l´Alimentació. Universitat de Barcelona
Publications:

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Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT03886597    
Other Study ID Numbers: IIBSP-OLI-2016-23
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Polyphenols
Triterpenes
Olea europaea
Table Olives
Pharmacokinetics
Functional Food
Antioxidant
Cardiovascular Disease
Anti-inflammatory