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Completed

NCT Number: NCT03140397

Oral Bioavailability and Bioactivity of Prenylflavonoids From Hops

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.

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Key information

Conditions

Safety After Oral Intake Immune Cells Activity Pharmacokinetics After Oral Intake

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Hohenheim, Stuttgart, Baden-Wurttemberg, Germany

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

6-prenylnaringenin

Dietary Supplement

Other names: 6-PN

8-prenylnaringenin

Dietary Supplement

Other names: 8-PN

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Hohenheim

Other

Collaborators

  • Universität Tübingen

Registry information

Official study title

Examination of the Bioavailability and Bioactivity of the Two Natural Food Ingredients 6-Prenylnaringenin and 8-Prenylnaringenin.

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 4, 2017
Registry last updated
Mar 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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