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| Name | Class |
|---|---|
| Universidad Católica San Antonio de Murcia | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum ESIT12 D | Experimental | This arm receives 400 mg of ESIT12 and 150 mg of carriers from ESIT12 |
|
| Verum ESIT12 4D | Experimental | This arm receives 1600 mg of ESIT12 and 600 mg of carriers from ESIT12 |
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| Placebo | Placebo Comparator | This arm receives 550 mg of carriers from ESIT12 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESIT12 D | Dietary Supplement | ESIT12 is a poplar-type propolis powder extract containing phenolic compounds from flavonoids and phenolic acids family. ESIT12 D contains 400 mg of ESIT12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in plasma area under the curve (AUC) of phenolic metabolites after acute ingestion of the supplement/placebo | 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. | Baseline (pre-ingestion) to 24 hour post-ingestion |
| Change in plasma maximal concentration (Cmax) of phenolic metabolites after acute ingestion of the supplement/placebo | 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. | 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 |
| Change in plasma time to reach maximal concentration (Tmax) of phenolic metabolites after acute ingestion of the supplement/placebo | 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. | 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 |
| Change in urine area under the curve (AUC) phenolic metabolites excretion after acute ingestion of the supplement/placebo | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Male and female with 40% min. and 60% max. of each sex.
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| Name | Affiliation | Role |
|---|---|---|
| Pedro E. Alcaraz, PhD | UCAM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Católica San Antonio de Murcia | Guadalupe | Murcia | 30107 | Spain |
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| ESIT12 4D | Dietary Supplement | ESIT12 is a poplar-type propolis powder extract containing phenolic compounds from flavonoids and phenolic acids family. ESIT12 4D contains 1600 mg of ESIT12 |
|
| Placebo | Dietary Supplement | Placebo is composed of the carriers of ESIT12 : arabic gum, sucrose and silicon dioxide mix |
|
| Baseline (pre-ingestion) to 48 hour post-ingestion |
| Change in urine maximal concentration (Cmax) phenolic metabolites excretion after acute ingestion of the supplement/placebo | 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. | 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 |
| Change in urine time to reach maximal concentration (Tmax) phenolic metabolites excretion after acute ingestion of the supplement/placebo | 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. | 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 |