Hop Compounds on the Immune System (VH)

April 10, 2025 updated by: Prof. Dr. Ina Bergheim, University of Vienna

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Xanthohumol
Participants receive a study drink supplemented with Xanthohumol (0mg = Placebo; 0,125 mg; 0,375 mg or 0,75 mg soluble Xanthohumol)
Dietary supplement: Xanthohumol
Participants receive a study drink supplemented with Xanthohumol (0 mg = Placebo, 0,125 mg, 0,375 mg or 0,75 mg soluble Xanthohumol)
Experimental: Iso-alpha-Acids
Participants receive a study drink supplemented with Xanthohumol (0 mg = Placebo; 15 mg, 45 mg or 90 mg Iso-alpha-Acids)
Dietary supplement: Iso-alpha-Acids
Participants receive a study drink supplemented with Iso-alpha-Acids (0 mg = Placebo, 15 mg, 45 mg or 90 mg Iso-alpha-Acids)
Experimental: Xanthohumol/Iso-alpha-Acids
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)
Dietary supplement: Xanthohumol + Iso-alpha-Acids
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 hours
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.
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vienna

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 (Actual)

May 30, 2022

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

January 17, 2024

First Submitted That Met QC Criteria

February 21, 2024

First Posted (Actual)

February 29, 2024

Study Record Updates

Last Update Posted (Actual)

April 15, 2025

Last Update Submitted That Met QC Criteria

April 10, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UVienna23

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

product manufactured in and exported from the U.S.

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.

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