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NCT Number: NCT06286644

Hop Compounds on the Immune System (VH)

The aim of the present study is to determine the effect of Iso-alpha-Acids and Xanthohumol from hops on the immune response of healthy participants over a timeframe of 6 hours.

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Key information

Conditions

Inflammatory Response

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

In this placebo-controlled crossover study a study drink enriched with either a placebo, Xanthohumol, Iso-alpha Acids or a combination of latter is given to the participants. A washout phase before intervention and between each intervention is introduced. On day one of each intervention blood is drawn in fasted state from each participant. Subsequently the study drink combined with a standardized breakfast is given to the participants followed by blood draws 1, 2, 3, 4 and 6 hours after the consumption of the study drink. To assess the effect of Xanthohumol and Iso-alpha acids or a combination of both, clinical parameters, blood lipids, blood glucose, uric acid and inflammatory markers will be determined. Furthermore, blood cells, isolated from blood samples of each time point, will be stimulated for measuring inflammatory markers.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy
  • BMI: >18,5 kg/m² or <30 kg/m²

Exclusion criteria

  • food intolerances
  • food allergies
  • chronic inflammatory diseases
  • metabolic diseases
  • viral or bacterial infections within the last 3 weeks of inclusion
  • intake of immunosuppressive medication

Treatment and study plan

Xanthohumol

Dietary Supplement

Participants receive a study drink supplemented with Xanthohumol (0 mg = Placebo, 0,125 mg, 0,375 mg or 0,75 mg soluble Xanthohumol)

Iso-alpha-Acids

Dietary Supplement

Participants receive a study drink supplemented with Iso-alpha-Acids (0 mg = Placebo, 15 mg, 45 mg or 90 mg Iso-alpha-Acids)

Xanthohumol + Iso-alpha-Acids

Dietary Supplement

Participants receive a study drink supplemented with Xanthohumol + Iso-alpha-Acids (0 mg = Placebo, 0,125 mg + 15 mg , 0,375 mg + 45 mg or 0,75 mg + 90 mg soluble Xanthohumol + Iso-alpha-Acids)

Primary outcomes

  1. Changes in parameters of immune response

    Time frame: 6 hours

    Changes in concentration of interleukin 6 (ng/ml) in cell culture supernatant of stimulated cells.

  2. Changes in parameters of immune response

    Time frame: 6 hours

    Changes in concentration of interleukin 1 beta (ng/ml) in cell culture supernatant of stimulated cells.

Study contacts

Contact information is provided by the study sponsor or research team.

Ina Bergheim, Prof. Dr.

CONTACT

[email protected]

+43-1-4277-54981

Sponsors and collaborators

Lead sponsor

University of Vienna

Other

Registry information

Official study title

Effect of Iso-alpha Acids and Xanthohumol on the Human Immune System

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 29, 2024
Registry last updated
Apr 15, 2025

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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