Clinical trial NCT06062511: Poplar-type Propolis Dry Extract ESIT12 : Nutrikinetic and Bioavailability Studies
Official title: Evaluation of Nutrikinetic and Bioavailability of Phenolic Compounds From ESIT12, a Poplar-type Propolis Dry Extract
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition, Healthy
Lead sponsor: Fytexia
Sponsor class: INDUSTRY
Collaborators: name: Universidad Católica San Antonio de Murcia
First posted: 2023-10-02
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to investigate phenolic compounds from ESIT12, a poplar-type propolis ingredient, bioavailability and nutrikinetics by measuring urinary excretion and metabolic profile over 48h by means of high-performance liquid chromatography coupled with tandem mass spectrometry (HPLC-MS/MS). The study follows a cross-over, double-blind, randomized and placebo control design on 10 healthy subjects.


Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Male and female with 40% min. and 60% max. of each sex.
4. Aged 25 to 69 years old
5. BMI range (18.5 - 29.99)
6. In good general health as evidenced by medical history
7. Ability to take oral supplementation and be willing to adhere to the regimen
8. Agreement to adhere to Lifestyle Considerations (controlled diet) throughout study duration

Exclusion Criteria:

1. Current use of any medication or food supplement
2. Antibiotic use less than 12 weeks before the study
3. Pregnancy or lactation
4. Known allergic reactions to components of the supplement, i.e., bee products (specially propolis) and known allergy (general)
5. Metabolic disorders or any kind of disease
6. Current smoker

Primary outcomes:
measure: Change in plasma area under the curve (AUC) of phenolic metabolites after acute ingestion of the supplement/placebo
timeFrame: Baseline (pre-ingestion) to 24 hour post-ingestion
measure: Change in plasma maximal concentration (Cmax) of phenolic metabolites after acute ingestion of the supplement/placebo
timeFrame: Baseline (pre-ingestion) and 0.5 hour, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 24 hour post-ingestion
measure: Change in plasma time to reach maximal concentration (Tmax) of phenolic metabolites after acute ingestion of the supplement/placebo
timeFrame: Baseline (pre-ingestion) and 0.5 hour, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 24 hour post-ingestion
measure: Change in urine area under the curve (AUC) phenolic metabolites excretion after acute ingestion of the supplement/placebo
timeFrame: Baseline (pre-ingestion) to 48 hour post-ingestion
measure: Change in urine maximal concentration (Cmax) phenolic metabolites excretion after acute ingestion of the supplement/placebo
timeFrame: Baseline (pre-ingestion) and 0 hour - 3 hour, 3 hour - 6 hour, 6 hour - 10 hour, 10 hour - 14 hour, 14 hour - 24 hour, 24 hour - 36 hour and 36 hour - 48 hour post-ingestion
measure: Change in urine time to reach maximal concentration (Tmax) phenolic metabolites excretion after acute ingestion of the supplement/placebo
timeFrame: Baseline (pre-ingestion) and 0 hour - 3 hour, 3 hour - 6 hour, 6 hour - 10 hour, 10 hour - 14 hour, 14 hour - 24 hour, 24 hour - 36 hour and 36 hour - 48 hour post-ingestion
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalupe
country: Spain
facility: Universidad Católica San Antonio de Murcia
state: Murcia
Study officials:
affiliation: UCAM
name: Pedro E. Alcaraz, PhD
role: PRINCIPAL_INVESTIGATOR
References: