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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03140397 |
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Date of registration:
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02/05/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Oral Bioavailability and Bioactivity of Prenylflavonoids From Hops
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Scientific title:
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Examination of the Bioavailability and Bioactivity of the Two Natural Food Ingredients 6-Prenylnaringenin and 8-Prenylnaringenin. |
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Date of first enrolment:
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January 2016 |
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Target sample size:
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16 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03140397 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Double (Participant, Investigator).
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Phase:
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Early Phase 1
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Countries of recruitment
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Germany
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Contacts
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Name:
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Christian Busch, Dr. med. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eberhard Karls University Tuebingen |
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Name:
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Jan Frank, Prof. Dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Hohenheim |
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Name:
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Sascha Venturelli, Dr. med. Dr. rer. nat. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eberhard Karls University Tuebingen |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy Volunteers with blood chemistry values within normal ranges
- Age: 18-45 years
- BMI: 19-25 kg/m2
Exclusion Criteria:
- Pregnancy or lactation
- Alcohol and/or drug abuse
- Use of dietary supplements or any medications, except contraceptives
- Any known malignant, metabolic and endocrine diseases
- Previous cardiac infarction
- Dementia
- Participation in a clinical trial within the past 6 weeks prior to recruitment
- Physical activity of more than 5 h/wk
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Immune Cells Activity
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Safety After Oral Intake
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Pharmacokinetics After Oral Intake
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Intervention(s)
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Dietary Supplement: Placebo
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Dietary Supplement: 6-prenylnaringenin
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Dietary Supplement: 8-prenylnaringenin
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Primary Outcome(s)
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Cell count (dead cells/ml and living cells/ml) of PBMCs after 8-PN administration
[Time Frame: 0, 6, and 24 h post dose]
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Mean maximum plasma concentration (Cmax) of total 6-prenylnaringenin [nmol/L]
[Time Frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose]
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Mean maximum plasma concentration (Cmax) of total 8-prenylnaringenin [nmol/L]
[Time Frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose]
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Cumulative urinary excretion of total 6-prenylnaringenin [nmol/g creatinine]
[Time Frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose]
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Mean area under the curve (AUC) of plasma concentration vs. time of total 6-prenylnaringenin [nmol/L*h]
[Time Frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose]
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Cell count (dead cells/ml and living cells/ml) of PBMCs after 6-PN administration
[Time Frame: 0, 6, and 24 h post dose]
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Cumulative urinary excretion of total 8-prenylnaringenin [nmol/g creatinine]
[Time Frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose]
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Cell viability of PBMCs after 8-PN administration
[Time Frame: 0, 6, and 24 h post dose]
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Time to reach maximum plasma concentration (Tmax) of total 6-prenylnaringenin [h]
[Time Frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose]
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Cell viability of PBMCs after 6-PN administration
[Time Frame: 0, 6, and 24 h post dose]
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Mean area under the curve (AUC) of plasma concentration vs. time of total 8-prenylnaringenin [nmol/L*h]
[Time Frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose]
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Time to reach maximum plasma concentration (Tmax) of total 8-prenylnaringenin [h]
[Time Frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose]
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Secondary Outcome(s)
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Serum alanine transaminase activity [U/L]
[Time Frame: 0, 4, 24h post-dose]
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Serum LDL cholesterol [mg/dL]
[Time Frame: 0, 4, 24h post-dose]
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Hematocrit [%]
[Time Frame: 0, 24h post-dose]
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Hemoglobin [g/dL]
[Time Frame: 0, 24h post-dose]
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Serum glucose [mg/dL]
[Time Frame: 0, 24h post-dose]
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Serum HDL cholesterol [mg/dL]
[Time Frame: 0, 4, 24h post-dose]
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Glomerular filtration rate [mL/min]
[Time Frame: 0, 4, 24h post-dose]
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Lymphocytes [%]
[Time Frame: 0, 24h post-dose]
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Serum triacylglycerols [mg/dL]
[Time Frame: 0, 4, 24h post-dose]
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Serum creatinine [mg/dL]
[Time Frame: 0, 4, 24h post-dose]
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Serum cystatin C [mg/mL]
[Time Frame: 0, 4, 24h post-dose]
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Eosinophil granulocytes [%]
[Time Frame: 0, 24h post-dose]
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Monocytes [%]
[Time Frame: 0, 24h post-dose]
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Basophil granulocytes [%]
[Time Frame: 0, 24h post-dose]
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Serum alkaline phosphatase activity [U/L]
[Time Frame: 0, 4, 24h post-dose]
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Serum uric acid [mg/dL]
[Time Frame: 0, 4, 24h post-dose]
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Erythrocytes [/pL]
[Time Frame: 0, 24h post-dose]
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Leucocytes [/nL]
[Time Frame: 0, 24h post-dose]
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Serum bilirubin
[Time Frame: 0, 4, 24h post-dose]
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Serum gamma-glutamyl transferase activity [U/L]
[Time Frame: 0, 4, 24h post-dose]
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Thrombocytes [/nL]
[Time Frame: 0, 24h post-dose]
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Serum total cholesterol [mg/dL]
[Time Frame: 0, 4, 24h post-dose]
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Mean corpuscular hemoglobin [pg]
[Time Frame: 0, 24h post-dose]
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Segmented granulocytes [%]
[Time Frame: 0, 24h post-dose]
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Serum aspartate transaminase activity [U/L]
[Time Frame: 0, 4, 24h post-dose]
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LDL/HDL cholesterol ratio
[Time Frame: 0, 4, 24h post-dose]
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Mean corpuscular hemoglobin concentration [g/dL]
[Time Frame: 0, 24h post-dose]
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Mean corpuscular volume [fL]
[Time Frame: 0, 24h post-dose]
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Secondary ID(s)
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HS-PF1-2016
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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