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Trial record 24 of 29 for:    GUSB

Oral Bioavailability and Bioactivity of Prenylflavonoids From Hops

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ClinicalTrials.gov Identifier: NCT03140397
Recruitment Status : Completed
First Posted : May 4, 2017
Last Update Posted : March 30, 2018
Sponsor:
Collaborator:
Universität Tübingen
Information provided by (Responsible Party):
University of Hohenheim

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Safety After Oral Intake Pharmacokinetics After Oral Intake Immune Cells Activity Dietary Supplement: Placebo Dietary Supplement: 6-prenylnaringenin Dietary Supplement: 8-prenylnaringenin Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Examination of the Bioavailability and Bioactivity of the Two Natural Food Ingredients 6-Prenylnaringenin and 8-Prenylnaringenin.
Study Start Date : January 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : December 31, 2017

Arm Intervention/treatment
Placebo Comparator: Placebo
Capsules filled with mannitol and silicon dioxide
Dietary Supplement: Placebo
Experimental: 6-prenylnaringenin
500 mg 6-PN plus mannitol and silicon dioxide
Dietary Supplement: 6-prenylnaringenin
Other Name: 6-PN

Experimental: 8-prenylnaringenin
500 mg 8-PN plus mannitol and silicon dioxide
Dietary Supplement: 8-prenylnaringenin
Other Name: 8-PN




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. Cell count (dead cells/ml and living cells/ml) of PBMCs after 6-PN administration [ Time Frame: 0, 6, and 24 h post dose ]
  10. Cell count (dead cells/ml and living cells/ml) of PBMCs after 8-PN administration [ Time Frame: 0, 6, and 24 h post dose ]
  11. Cell viability of PBMCs after 6-PN administration [ Time Frame: 0, 6, and 24 h post dose ]
  12. Cell viability of PBMCs after 8-PN administration [ Time Frame: 0, 6, and 24 h post dose ]

Secondary Outcome Measures :
  1. Serum aspartate transaminase activity [U/L] [ Time Frame: 0, 4, 24h post-dose ]
  2. Serum alanine transaminase activity [U/L] [ Time Frame: 0, 4, 24h post-dose ]
  3. Serum gamma-glutamyl transferase activity [U/L] [ Time Frame: 0, 4, 24h post-dose ]
  4. Serum alkaline phosphatase activity [U/L] [ Time Frame: 0, 4, 24h post-dose ]
  5. Serum bilirubin [ Time Frame: 0, 4, 24h post-dose ]
  6. Serum uric acid [mg/dL] [ Time Frame: 0, 4, 24h post-dose ]
  7. Serum creatinine [mg/dL] [ Time Frame: 0, 4, 24h post-dose ]
  8. Serum total cholesterol [mg/dL] [ Time Frame: 0, 4, 24h post-dose ]
  9. Serum HDL cholesterol [mg/dL] [ Time Frame: 0, 4, 24h post-dose ]
  10. Serum LDL cholesterol [mg/dL] [ Time Frame: 0, 4, 24h post-dose ]
  11. Serum triacylglycerols [mg/dL] [ Time Frame: 0, 4, 24h post-dose ]
  12. LDL/HDL cholesterol ratio [ Time Frame: 0, 4, 24h post-dose ]
  13. Serum cystatin C [mg/mL] [ Time Frame: 0, 4, 24h post-dose ]
  14. Glomerular filtration rate [mL/min] [ Time Frame: 0, 4, 24h post-dose ]
  15. Serum glucose [mg/dL] [ Time Frame: 0, 24h post-dose ]
  16. Hemoglobin [g/dL] [ Time Frame: 0, 24h post-dose ]
  17. Mean corpuscular hemoglobin concentration [g/dL] [ Time Frame: 0, 24h post-dose ]
  18. Mean corpuscular hemoglobin [pg] [ Time Frame: 0, 24h post-dose ]
  19. Mean corpuscular volume [fL] [ Time Frame: 0, 24h post-dose ]
  20. Hematocrit [%] [ Time Frame: 0, 24h post-dose ]
  21. Erythrocytes [/pL] [ Time Frame: 0, 24h post-dose ]
  22. Thrombocytes [/nL] [ Time Frame: 0, 24h post-dose ]
  23. Leucocytes [/nL] [ Time Frame: 0, 24h post-dose ]
  24. Segmented granulocytes [%] [ Time Frame: 0, 24h post-dose ]
  25. Lymphocytes [%] [ Time Frame: 0, 24h post-dose ]
  26. Monocytes [%] [ Time Frame: 0, 24h post-dose ]
  27. Basophil granulocytes [%] [ Time Frame: 0, 24h post-dose ]
  28. Eosinophil granulocytes [%] [ Time Frame: 0, 24h post-dose ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03140397


Locations
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Germany
University of Hohenheim
Stuttgart, Baden-Württemberg, Germany, 70599
Eberhard Karls University Tuebingen
Tübingen, Baden-Württemberg, Germany, 72076
Sponsors and Collaborators
University of Hohenheim
Universität Tübingen
Investigators
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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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Hohenheim
ClinicalTrials.gov Identifier: NCT03140397     History of Changes
Other Study ID Numbers: HS-PF1-2016
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Hohenheim:
Bioavailability
Pharmacokinetics
8-prenylnaringenin
6-prenylnaringenin
Prenylflavonoids
PBMC
Additional relevant MeSH terms:
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8-prenylnaringenin
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs