Hop Compounds on the Immune System (VH)

Inflammatory Response Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06286644
• Other study ID #: UVienna23
• Status: Recruiting
• Phase: N/A
• Start date: May 30, 2022
• 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 the effect of Iso-alpha-Acids and Xanthohumol from hops on the immune response of healthy participants over a timeframe of 6 hours.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: December 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Response

Intervention

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)
• 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)
• 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)

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 parameters of immune response	Changes in concentration of interleukin 6 (ng/ml) in cell culture supernatant of stimulated cells.	6 hours
Primary	Changes in parameters of immune response	Changes in concentration of interleukin 1 beta (ng/ml) in cell culture supernatant of stimulated cells.	6 hours