NCT06286644

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2022

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 29, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

April 15, 2025

Status Verified

April 1, 2025

Enrollment Period

3.4 years

First QC Date

January 17, 2024

Last Update Submit

April 10, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Changes in parameters of immune response

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

    6 hours

  • Changes in parameters of immune response

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

    6 hours

Study Arms (3)

Xanthohumol

EXPERIMENTAL

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

Iso-alpha-Acids

EXPERIMENTAL

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

Xanthohumol/Iso-alpha-Acids

EXPERIMENTAL

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

Interventions

XanthohumolDIETARY_SUPPLEMENT

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

Xanthohumol
Iso-alpha-AcidsDIETARY_SUPPLEMENT

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

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)

Xanthohumol/Iso-alpha-Acids

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • food intolerances
  • food allergies
  • chronic inflammatory diseases
  • metabolic diseases
  • intake of immunosuppressive medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Interventions

xanthohumol

Central Study Contacts

Ina Bergheim, Prof. Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 17, 2024

First Posted

February 29, 2024

Study Start

May 30, 2022

Primary Completion

October 31, 2025

Study Completion

December 30, 2025

Last Updated

April 15, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations