Xanthohumol and Viral Infections (XL)

Infection Viral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06286657
• Other study ID #: UVienna23a
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2024
• Source: University of Vienna
• Contact: Ina Bergheim, Prof. Dr.
• Phone: +43-1-4277-54981
• Email: ina.bergheim[@]univie.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection Viral
• Infections
• Virus Diseases

Intervention

Dietary Supplement:
• Xanthohumol
Participants consume twice per day a study drink which contains 0,75 mg soluble Xanthohumol for 90 days
• Placebo
Participants consume twice per day a study drink which contains 0 mg soluble Xanthohumol for 90 days

Locations

Country	Name	City	State
Austria	University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in severity and duration of viral infections	Changes in score of Wisconsin Upper Respiratory Symptom Survey	90 days
Secondary	Changes in blood lipid levels	Changes in triglyceride levels (mg/dl) and cholesterol levels (mg/dl)	90 days
Secondary	Changes in cognitive skills	Assessment of cognitive processes using stroop test	90 days