Nutritional Intervention With Table Olives in Healthy Volunteers

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

March 25, 2019

Primary Completion Date

May 25, 2019

Study Completion Date

June 15, 2019

Conditions
HealthyBiological AvailabilityNutritional InterventionFunctional FoodNutrition Physiology
Interventions
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.

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.

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.

Trial Locations (1)

08041

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

All Listed Sponsors
collaborator

Ministerio de Economía y Competitividad (Spain) AGL 2013-41188R

UNKNOWN

collaborator

University of Barcelona

OTHER

lead

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

OTHER

NCT03886597 - Nutritional Intervention With Table Olives in Healthy Volunteers | Biotech Hunter | Biotech Hunter