Safety After Oral IntakeEarly Phase 1NCT03140397
Oral Bioavailability and Bioactivity of Prenylflavonoids From Hops
A Early Phase 1 study testing 6-prenylnaringenin and 8-prenylnaringenin in people with Safety After Oral Intake and Pharmacokinetics After Oral Intake, run by University of Hohenheim at 2 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety After Oral Intake, Pharmacokinetics After Oral Intake, Immune Cells Activity
- What is being tested?
- 6-prenylnaringenin and 8-prenylnaringenin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2016to 31 Dec 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Volunteers with blood chemistry values within normal ranges
- Age: 18-45 years
- BMI: 19-25 kg/m2
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University of Hohenheim
Stuttgart, Baden-Wurttemberg, 70599
Eberhard Karls University Tuebingen
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: 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.
- Being tested
- Placebo, 6-prenylnaringenin, 8-prenylnaringenin
- Keywords
- Bioavailability, Pharmacokinetics, 8-prenylnaringenin, 6-prenylnaringenin, Prenylflavonoids, PBMC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
6-prenylnaringeninDietary supplement
Also called 6-PN
8-prenylnaringeninDietary supplement
Also called 8-PN
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Capsules filled with mannitol and silicon dioxide Receives: Dietary Supplement: Placebo |
| 6-prenylnaringenin | Experimental | 500 mg 6-PN plus mannitol and silicon dioxide Receives: Dietary Supplement: 6-prenylnaringenin |
| 8-prenylnaringenin | Experimental | 500 mg 8-PN plus mannitol and silicon dioxide Receives: Dietary Supplement: 8-prenylnaringenin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean area under the curve (AUC) of plasma concentration vs. time of total 6-prenylnaringenin [nmol/L*h]
Total 6-PN after deconjugation with beta-glucuronidase/sulphatase
Measured: 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]
Total trans-epsilon-viniferin after deconjugation with beta-glucuronidase/sulphatase
Measured: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Mean maximum plasma concentration (Cmax) of total 6-prenylnaringenin [nmol/L]
Total trans-resveratrol after deconjugation with beta-glucuronidase/sulphatase
Measured: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Mean maximum plasma concentration (Cmax) of total 8-prenylnaringenin [nmol/L]
Total trans-epsilon-viniferin after deconjugation with beta-glucuronidase/sulphatase
Measured: 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]
Total trans-resveratrol after deconjugation with beta-glucuronidase/sulphatase
Measured: 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]
Total trans-epsilon-viniferin after deconjugation with beta-glucuronidase/sulphatase
Measured: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Cumulative urinary excretion of total 6-prenylnaringenin [nmol/g creatinine]
Total trans-resveratrol after deconjugation with beta-glucuronidase/sulphatase
Measured: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Cumulative urinary excretion of total 8-prenylnaringenin [nmol/g creatinine]
Total trans-epsilon-viniferin after deconjugation with beta-glucuronidase/sulphatase
Measured: 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
Measured: 0, 6, and 24 h post dose
Cell count (dead cells/ml and living cells/ml) of PBMCs after 8-PN administration
Measured: 0, 6, and 24 h post dose
Cell viability of PBMCs after 6-PN administration
Measured: 0, 6, and 24 h post dose
Cell viability of PBMCs after 8-PN administration
Measured: 0, 6, and 24 h post dose
Secondary outcomes (28)
Serum aspartate transaminase activity [U/L]
Measured: 0, 4, 24h post-dose
Serum alanine transaminase activity [U/L]
Measured: 0, 4, 24h post-dose
Serum gamma-glutamyl transferase activity [U/L]
Measured: 0, 4, 24h post-dose
Serum alkaline phosphatase activity [U/L]
Measured: 0, 4, 24h post-dose
Serum bilirubin
Measured: 0, 4, 24h post-dose
Serum uric acid [mg/dL]
Measured: 0, 4, 24h post-dose
Serum creatinine [mg/dL]
Measured: 0, 4, 24h post-dose
Serum total cholesterol [mg/dL]
Measured: 0, 4, 24h post-dose
Serum HDL cholesterol [mg/dL]
Measured: 0, 4, 24h post-dose
Serum LDL cholesterol [mg/dL]
Measured: 0, 4, 24h post-dose
Serum triacylglycerols [mg/dL]
Measured: 0, 4, 24h post-dose
LDL/HDL cholesterol ratio
Measured: 0, 4, 24h post-dose
Serum cystatin C [mg/mL]
Measured: 0, 4, 24h post-dose
Glomerular filtration rate [mL/min]
Measured: 0, 4, 24h post-dose
Serum glucose [mg/dL]
Measured: 0, 24h post-dose
Hemoglobin [g/dL]
Measured: 0, 24h post-dose
Mean corpuscular hemoglobin concentration [g/dL]
Measured: 0, 24h post-dose
Mean corpuscular hemoglobin [pg]
Measured: 0, 24h post-dose
Mean corpuscular volume [fL]
Measured: 0, 24h post-dose
Hematocrit [%]
Measured: 0, 24h post-dose
Erythrocytes [/pL]
Measured: 0, 24h post-dose
Thrombocytes [/nL]
Measured: 0, 24h post-dose
Leucocytes [/nL]
Measured: 0, 24h post-dose
Segmented granulocytes [%]
Measured: 0, 24h post-dose
Lymphocytes [%]
Measured: 0, 24h post-dose
Monocytes [%]
Measured: 0, 24h post-dose
Basophil granulocytes [%]
Measured: 0, 24h post-dose
Eosinophil granulocytes [%]
Measured: 0, 24h post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study startJan 2016
- Primary completionApr 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Safety After Oral IntakeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hohenheim
- Sponsor type
- University, hospital or other
- Collaborators
- Universität Tübingen
- Responsible party
- Sponsor
- Investigators
- Jan Frank, Prof. Dr., Principal investigator, University of HohenheimSascha Venturelli, Dr. med. Dr. rer. nat., Principal investigator, Eberhard Karls University TuebingenChristian Busch, Dr. med., Principal investigator, Eberhard Karls University Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140397
- Sponsor's protocol ID
- HS-PF1-2016
- Status last verified
- Mar 2018
- First submitted
- 2 May 2017
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Calvo-Castro LA, Burkard M, Sus N, Scheubeck G, Leischner C, Lauer UM, Bosy-Westphal A, Hund V, Busch C, Venturelli S, Frank J. The Oral Bioavailability of 8-Prenylnaringenin from Hops (Humulus Lupulus L.) in Healthy Women and Men is Significantly Higher than that of its Positional Isomer 6-Prenylnaringenin in a Randomized Crossover Trial. Mol Nutr Food Res. 2018 Apr;62(7):e1700838. doi: 10.1002/mnfr.201700838. Epub 2018 Mar 1.
PubMed 29363261
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Bioavailability and Bioactivity of the Two Natural Food Ingredients 6-Prenylnaringenin and 8-Prenylnaringenin.
- ClinicalTrials.gov ID
- NCT03140397
- Acronym / sponsor ID
- HS-PF1-2016
- Keywords
- Bioavailability, Pharmacokinetics, 8-prenylnaringenin, 6-prenylnaringenin, Prenylflavonoids, PBMC
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of HohenheimUniversity, hospital or other
- Collaborators
- Universität Tübingen
- Study start
- Jan 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 4 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboCapsules filled with mannitol and silicon dioxide |
| 6-prenylnaringenin | Experimental | Dietary Supplement: 6-prenylnaringenin500 mg 6-PN plus mannitol and silicon dioxide |
| 8-prenylnaringenin | Experimental | Dietary Supplement: 8-prenylnaringenin500 mg 8-PN plus mannitol and silicon dioxide |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy Volunteers with blood chemistry values within normal ranges
- Age: 18-45 years
- BMI: 19-25 kg/m2
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo | Dietary supplement | Placebo |
| 6-prenylnaringeninAlso: 6-PN | Dietary supplement | 6-prenylnaringenin |
| 8-prenylnaringeninAlso: 8-PN | Dietary supplement | 8-prenylnaringenin |
Primary outcome
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
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
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
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
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
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
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
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
Cell count (dead cells/ml and living cells/ml) of PBMCs after 6-PN administration
Time frame: 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
Cell viability of PBMCs after 6-PN administration
Time frame: 0, 6, and 24 h post dose
Cell viability of PBMCs after 8-PN administration
Time frame: 0, 6, and 24 h post dose
28 secondary outcomes
Serum aspartate transaminase activity [U/L]
Time frame: 0, 4, 24h post-dose
Serum alanine transaminase activity [U/L]
Time frame: 0, 4, 24h post-dose
Serum gamma-glutamyl transferase activity [U/L]
Time frame: 0, 4, 24h post-dose
Serum alkaline phosphatase activity [U/L]
Time frame: 0, 4, 24h post-dose
Serum bilirubin
Time frame: 0, 4, 24h post-dose
Serum uric acid [mg/dL]
Time frame: 0, 4, 24h post-dose
Serum creatinine [mg/dL]
Time frame: 0, 4, 24h post-dose
Serum total cholesterol [mg/dL]
Time frame: 0, 4, 24h post-dose
Serum HDL cholesterol [mg/dL]
Time frame: 0, 4, 24h post-dose
Serum LDL cholesterol [mg/dL]
Time frame: 0, 4, 24h post-dose
Serum triacylglycerols [mg/dL]
Time frame: 0, 4, 24h post-dose
LDL/HDL cholesterol ratio
Time frame: 0, 4, 24h post-dose
Serum cystatin C [mg/mL]
Time frame: 0, 4, 24h post-dose
Glomerular filtration rate [mL/min]
Time frame: 0, 4, 24h post-dose
Serum glucose [mg/dL]
Time frame: 0, 24h post-dose
Hemoglobin [g/dL]
Time frame: 0, 24h post-dose
Mean corpuscular hemoglobin concentration [g/dL]
Time frame: 0, 24h post-dose
Mean corpuscular hemoglobin [pg]
Time frame: 0, 24h post-dose
Mean corpuscular volume [fL]
Time frame: 0, 24h post-dose
Hematocrit [%]
Time frame: 0, 24h post-dose
Erythrocytes [/pL]
Time frame: 0, 24h post-dose
Thrombocytes [/nL]
Time frame: 0, 24h post-dose
Leucocytes [/nL]
Time frame: 0, 24h post-dose
Segmented granulocytes [%]
Time frame: 0, 24h post-dose
Lymphocytes [%]
Time frame: 0, 24h post-dose
Monocytes [%]
Time frame: 0, 24h post-dose
Basophil granulocytes [%]
Time frame: 0, 24h post-dose
Eosinophil granulocytes [%]
Time frame: 0, 24h post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
- Derived from this study: PubMed 29363261Calvo-Castro LA, Burkard M, Sus N, Scheubeck G, Leischner C, Lauer UM, Bosy-Westphal A, Hund V, Busch C, Venturelli S, Frank J. The Oral Bioavailability of 8-Prenylnaringenin from Hops (Humulus Lupulus L.) in Healthy Women and Men is Significantly Higher than that of its Positional Isomer 6-Prenylnaringenin in a Randomized Crossover Trial. Mol Nutr Food Res. 2018 Apr;62(7):e1700838. doi: 10.1002/mnfr.201700838. Epub 2018 Mar 1.
- Website of the research groupLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Frank, Prof. Dr. principal investigator
University of Hohenheim
Sascha Venturelli, Dr. med. Dr. rer. nat. principal investigator
Eberhard Karls University Tuebingen
Christian Busch, Dr. med. principal investigator
Eberhard Karls University Tuebingen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 6-prenylnaringenin and 8-prenylnaringenin in people with Safety After Oral Intake and Pharmacokinetics After Oral Intake, run by University of Hohenheim at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03140397, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2018.