Nutrition, Healthy
Conditions
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.
Interventions
DIETARY_SUPPLEMENTESIT12 D
ESIT12 is a poplar-type propolis powder extract containing phenolic compounds from flavonoids and phenolic acids family. ESIT12 D contains 400 mg of ESIT12
DIETARY_SUPPLEMENTESIT12 4D
ESIT12 is a poplar-type propolis powder extract containing phenolic compounds from flavonoids and phenolic acids family. ESIT12 4D contains 1600 mg of ESIT12
DIETARY_SUPPLEMENTPlacebo
Placebo is composed of the carriers of ESIT12 : arabic gum, sucrose and silicon dioxide mix
Sponsors
Universidad Católica San Antonio de Murcia
Fytexia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 69 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in plasma area under the curve (AUC) of phenolic metabolites after acute ingestion of the supplement/placebo | Baseline (pre-ingestion) to 24 hour post-ingestion | Plasma samples will be collected in EDTA tubes in baseline before supplement/placebo intake (0h) and up to 24h according to the time frame. Phenolic compounds metabolites in plasma will be identified and quantified by HPLC-MS. Targeted metabolites are phenolic acids and flavonoids derivatives. For each identified and quantified metabolite the area under the curve (0-24 hour) in nmol/L-h is measured. |
| Change in plasma maximal concentration (Cmax) of phenolic metabolites after acute ingestion of the supplement/placebo | 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 | Plasma samples will be collected in EDTA tubes in baseline before supplement/placebo intake (0h) and up to 24h according to the time frame. Phenolic compounds metabolites in plasma will be identified and quantified by HPLC-MS. Targeted metabolites are phenolic acids and flavonoids derivatives. For each identified and quantified metabolite the maximal concentration in nmol/L is measured. |
| Change in plasma time to reach maximal concentration (Tmax) of phenolic metabolites after acute ingestion of the supplement/placebo | 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 | Plasma samples will be collected in EDTA tubes in baseline before supplement/placebo intake (0h) and up to 24h according to the time frame. Phenolic compounds metabolites in plasma will be identified and quantified by HPLC-MS. Targeted metabolites are phenolic acids and flavonoids derivatives. For each identified and quantified metabolite the time to reach maximum concentration in hour is measured. |
| Change in urine area under the curve (AUC) phenolic metabolites excretion after acute ingestion of the supplement/placebo | Baseline (pre-ingestion) to 48 hour post-ingestion | Urine samples will be collected in baseline (0h pre-ingestion) and up to 48h according to the time frame. Phenolic compounds metabolites in urine will be identified and quantified by HPLC-MS. Targeted metabolites are phenolic acids and flavonoids derivatives. For each identified and quantified metabolite the area under the curve (0-24 hour) in nmol/L-h is measured. |
| Change in urine maximal concentration (Cmax) phenolic metabolites excretion after acute ingestion of the supplement/placebo | 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 | Urine samples will be collected in baseline (0h pre-ingestion) and up to 48h according to the time frame. Phenolic compounds metabolites in urine will be identified and quantified by HPLC-MS. Targeted metabolites are phenolic acids and flavonoids derivatives. For each identified and quantified metabolite the maximal concentration in nmol/L is measured. |
| Change in urine time to reach maximal concentration (Tmax) phenolic metabolites excretion after acute ingestion of the supplement/placebo | 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 | Urine samples will be collected in baseline (0h pre-ingestion) and up to 48h according to the time frame. Phenolic compounds metabolites in urine will be identified and quantified by HPLC-MS. Targeted metabolites are phenolic acids and flavonoids derivatives. For each identified and quantified metabolite the time to reach maximum concentration in hour is measured. |
Countries
Spain
Outcome results
None listed