- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03140397
Oral Bioavailability and Bioactivity of Prenylflavonoids From Hops
March 29, 2018 updated by: University of Hohenheim
Examination of the Bioavailability and Bioactivity of the Two Natural Food Ingredients 6-Prenylnaringenin and 8-Prenylnaringenin.
The prenylflavonoids 6-prenylnaringenin (6-PN) and 8-prenylnaringenin (8-PN) are secondary plant substances, almost exclusively found in hops (Humulus lupulus).
Both compounds have known potential biological properties, but poor bioavailability due to their low oral absorption and retention.
Our study followed a single dose (500 mg 6- or 8-PN), placebo controlled, randomized, double-blind, three armed crossover study design with ≥2-week washout periods.
Plasma, PBMC and urine samples were collected at intervals up to 24 h after intake.
Investigators investigated the safety, pharmacokinetics and impact of oral prenylflavonoids on the function of cells of the immune system.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Baden-Württemberg
-
Stuttgart, Baden-Württemberg, Germany, 70599
- University of Hohenheim
-
Tübingen, Baden-Württemberg, Germany, 72076
- Eberhard Karls University Tuebingen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 43 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Capsules filled with mannitol and silicon dioxide
|
|
Experimental: 6-prenylnaringenin
500 mg 6-PN plus mannitol and silicon dioxide
|
Other Names:
|
Experimental: 8-prenylnaringenin
500 mg 8-PN plus mannitol and silicon dioxide
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Total 6-PN after deconjugation with beta-glucuronidase/sulphatase
|
0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
|
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
|
Total trans-epsilon-viniferin after deconjugation with beta-glucuronidase/sulphatase
|
0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
|
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
|
Total trans-resveratrol after deconjugation with beta-glucuronidase/sulphatase
|
0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
|
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
|
Total trans-epsilon-viniferin after deconjugation with beta-glucuronidase/sulphatase
|
0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
|
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
|
Total trans-resveratrol after deconjugation with beta-glucuronidase/sulphatase
|
0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
|
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
|
Total trans-epsilon-viniferin after deconjugation with beta-glucuronidase/sulphatase
|
0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
|
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
|
Total trans-resveratrol after deconjugation with beta-glucuronidase/sulphatase
|
0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
|
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
|
Total trans-epsilon-viniferin after deconjugation with beta-glucuronidase/sulphatase
|
0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
|
Cell count (dead cells/ml and living cells/ml) of PBMCs after 6-PN administration
Time Frame: 0, 6, and 24 h post dose
|
0, 6, and 24 h post dose
|
|
Cell count (dead cells/ml and living cells/ml) of PBMCs after 8-PN administration
Time Frame: 0, 6, and 24 h post dose
|
0, 6, and 24 h post dose
|
|
Cell viability of PBMCs after 6-PN administration
Time Frame: 0, 6, and 24 h post dose
|
0, 6, and 24 h post dose
|
|
Cell viability of PBMCs after 8-PN administration
Time Frame: 0, 6, and 24 h post dose
|
0, 6, and 24 h post dose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum aspartate transaminase activity [U/L]
Time Frame: 0, 4, 24h post-dose
|
0, 4, 24h post-dose
|
Serum alanine transaminase activity [U/L]
Time Frame: 0, 4, 24h post-dose
|
0, 4, 24h post-dose
|
Serum gamma-glutamyl transferase activity [U/L]
Time Frame: 0, 4, 24h post-dose
|
0, 4, 24h post-dose
|
Serum alkaline phosphatase activity [U/L]
Time Frame: 0, 4, 24h post-dose
|
0, 4, 24h post-dose
|
Serum bilirubin
Time Frame: 0, 4, 24h post-dose
|
0, 4, 24h post-dose
|
Serum uric acid [mg/dL]
Time Frame: 0, 4, 24h post-dose
|
0, 4, 24h post-dose
|
Serum creatinine [mg/dL]
Time Frame: 0, 4, 24h post-dose
|
0, 4, 24h post-dose
|
Serum total cholesterol [mg/dL]
Time Frame: 0, 4, 24h post-dose
|
0, 4, 24h post-dose
|
Serum HDL cholesterol [mg/dL]
Time Frame: 0, 4, 24h post-dose
|
0, 4, 24h post-dose
|
Serum LDL cholesterol [mg/dL]
Time Frame: 0, 4, 24h post-dose
|
0, 4, 24h post-dose
|
Serum triacylglycerols [mg/dL]
Time Frame: 0, 4, 24h post-dose
|
0, 4, 24h post-dose
|
LDL/HDL cholesterol ratio
Time Frame: 0, 4, 24h post-dose
|
0, 4, 24h post-dose
|
Serum cystatin C [mg/mL]
Time Frame: 0, 4, 24h post-dose
|
0, 4, 24h post-dose
|
Glomerular filtration rate [mL/min]
Time Frame: 0, 4, 24h post-dose
|
0, 4, 24h post-dose
|
Serum glucose [mg/dL]
Time Frame: 0, 24h post-dose
|
0, 24h post-dose
|
Hemoglobin [g/dL]
Time Frame: 0, 24h post-dose
|
0, 24h post-dose
|
Mean corpuscular hemoglobin concentration [g/dL]
Time Frame: 0, 24h post-dose
|
0, 24h post-dose
|
Mean corpuscular hemoglobin [pg]
Time Frame: 0, 24h post-dose
|
0, 24h post-dose
|
Mean corpuscular volume [fL]
Time Frame: 0, 24h post-dose
|
0, 24h post-dose
|
Hematocrit [%]
Time Frame: 0, 24h post-dose
|
0, 24h post-dose
|
Erythrocytes [/pL]
Time Frame: 0, 24h post-dose
|
0, 24h post-dose
|
Thrombocytes [/nL]
Time Frame: 0, 24h post-dose
|
0, 24h post-dose
|
Leucocytes [/nL]
Time Frame: 0, 24h post-dose
|
0, 24h post-dose
|
Segmented granulocytes [%]
Time Frame: 0, 24h post-dose
|
0, 24h post-dose
|
Lymphocytes [%]
Time Frame: 0, 24h post-dose
|
0, 24h post-dose
|
Monocytes [%]
Time Frame: 0, 24h post-dose
|
0, 24h post-dose
|
Basophil granulocytes [%]
Time Frame: 0, 24h post-dose
|
0, 24h post-dose
|
Eosinophil granulocytes [%]
Time Frame: 0, 24h post-dose
|
0, 24h post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jan Frank, Prof. Dr., University of Hohenheim
- Principal Investigator: Sascha Venturelli, Dr. med. Dr. rer. nat., Eberhard Karls University Tuebingen
- Principal Investigator: Christian Busch, Dr. med., Eberhard Karls University Tuebingen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2016
Primary Completion (Actual)
April 1, 2017
Study Completion (Actual)
December 31, 2017
Study Registration Dates
First Submitted
May 2, 2017
First Submitted That Met QC Criteria
May 3, 2017
First Posted (Actual)
May 4, 2017
Study Record Updates
Last Update Posted (Actual)
March 30, 2018
Last Update Submitted That Met QC Criteria
March 29, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS-PF1-2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Safety After Oral Intake
-
University of HohenheimGerman Federal Ministry of Economics and TechnologyCompletedSafety After Oral Intake | Pharmacokinetics After Oral IntakeGermany
-
University of HohenheimCompletedSafety After Oral Intake | Pharmacokinetics After Oral IntakeGermany
-
University of HohenheimCompletedSafety After Oral Intake | Pharmacokinetics After Oral IntakeGermany
-
University of HohenheimUniversität TübingenCompletedSafety of Native vs. Micellar 6-PN After Oral Intake | Pharmacokinetics of Native vs. Micellar 6-PN After Oral Intake | PBMC Activity After Native vs. Micellar 6-PN Oral IntakeGermany
-
Wageningen UniversityCompletedVegetable Intake After Weaning With Vegetables or Fruits | Fruit Intake After Weaning With Vegetables or FruitsNetherlands
-
PfizerCompletedSurvival Status at Day 30 After the Last IntakeFrance
-
Texas Christian UniversityCompletedOral Intake ReducedUnited States
-
University of ReadingQueen's University, Belfast; University of Bern; Wageningen UniversityNot yet recruitingOlder Adults | Food Intake | Oral Processing | Appetitive BehaviourUnited Kingdom
-
Fondation Ophtalmologique Adolphe de RothschildCompletedCombined Oral Contraceptives IntakeFrance
-
Cairo UniversityRecruitingMaternal Complications After Oral Anticoagulation When Initiated Early and Late After Caesarean Section Done for Patients With Mechanical Heart Valve ProsthesisEgypt
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States