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Completed

NCT Number: NCT03886597

Nutritional Intervention With Table Olives in Healthy Volunteers

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Institut de Recerca Hospital de la Santa Creu i Sant Pau - CIM Sant Pau

Barcelona, 08041, Spain

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Table Olives

Other

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Other

Collaborators

  • Ministerio de Economía y Competitividad (Spain) AGL 2013-41188R
  • University of Barcelona

Registry information

Official study title

Table Olives Nutritional Intervention: Pharmacokinetics of Polyphenols and Pentacyclic Triterpenes and Assessment of Antioxidant, Cardiovascular and Anti-inflammatory Biomarkers

Acronym: BIOLIVA

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 22, 2019
Registry last updated
Aug 8, 2019

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.

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