Institut de Recerca Hospital de la Santa Creu i Sant Pau - CIM Sant Pau
Barcelona, 08041, Spain
NCT Number: NCT03886597
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.
Looking for future studies?
Notify Me18 year–60 year
All sexes
Interventional
Phase 1 / Phase 2
Barcelona, 08041, Spain
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Time frame: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Time frame: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Time frame: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Time frame: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Time frame: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Time frame: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Time frame: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Time frame: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Time frame: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Time frame: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Time frame: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Time frame: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Time frame: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Time frame: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
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
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
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
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Other
Table Olives Nutritional Intervention: Pharmacokinetics of Polyphenols and Pentacyclic Triterpenes and Assessment of Antioxidant, Cardiovascular and Anti-inflammatory Biomarkers
Acronym: BIOLIVA
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.
Published trials that share one or more normalized conditions with this study.
NCT06318390
Cardiovascular Diseases, Cognition Disorders
Arlington, Texas, United States
View Trial DetailsNCT05987891
Cardiovascular Abnormalities, Cardiovascular Diseases
São Paulo, Brazil
View Trial DetailsNCT04262128
Behavior, Cardiovascular Diseases
Aurora, Colorado, United States
View Trial DetailsNCT06318377
Cardiovascular Diseases, Cognition Disorders
Arlington, Texas, United States
View Trial Details