Xanthohumol and Viral Infections (XL)

February 21, 2024 updated by: Prof. Dr. Ina Bergheim, University of Vienna

Xanthohumol in the Prevention of Virus-mediated Upper Respiratory Tract Infections in Humans

The aim of the present study is to determine if a regular oral supplementation of xanthohumol attenuate the severity of symptoms and duration of´viral infections.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this placebo-controlled study, blood is taken on the first day of the study, followed by a 90-day intervention with xanthohumol or a placebo, which is taken twice daily. Blood samples will be taken on day 0, day 45 and day 90. Should the study participants develop a respiratory infection during the study, they will be asked to perform a self-test.

Study Type

Interventional

Enrollment (Estimated)

100

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

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • University of Vienna
        • Contact:

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 kg/m² or < 28kg/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, severe acute respiratory syndrome coronavirus type 2-infection in the last 4 months, influenza infection in the "current" flu season

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Participants consume twice per day a study drink which contains 0,75 mg soluble Xanthohumol for 90 days
Dietary supplement: Xanthohumol
Participants consume twice per day a study drink which contains 0,75 mg soluble Xanthohumol for 90 days
Experimental: Placebo
Participants consume twice per day a study drink which contains 0 mg soluble Xanthohumol for 90 days
Dietary supplement: Placebo
Participants consume twice per day a study drink which contains 0 mg soluble Xanthohumol for 90 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in severity and duration of viral infections
Time Frame: 90 days
Changes in score of Wisconsin Upper Respiratory Symptom Survey
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in blood lipid levels
Time Frame: 90 days
Changes in triglyceride levels (mg/dl) and cholesterol levels (mg/dl)
90 days
Changes in cognitive skills
Time Frame: 90 days
Assessment of cognitive processes using stroop test
90 days

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)

August 1, 2023

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

January 17, 2024

First Submitted That Met QC Criteria

February 21, 2024

First Posted (Estimated)

February 29, 2024

Study Record Updates

Last Update Posted (Estimated)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UVienna23a

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

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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