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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04847193
Other study ID # UVienna19a
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 13, 2019
Est. completion date January 27, 2021

Study information

Verified date March 2022
Source University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the present study is to determine the effect of Xanthohumol and Iso-alpha-acids from hops on the immune response of healthy participants.


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 following a second blood drawing one hour after the consumption of the study drink. On the last day of each intervention blood is taken from study participants in the same manner as on day one. To assess the effect of Xanthohumol and Iso-alpha acids or a combination of both, clinical chemical parameters e.g. ALT, AST, γ-GT, blood lipids (triglycerides, total cholesterol, HDL, LDL), blood glucose, uric acid and CRP are determined. Furthermore, PBMC's isolated from blood samples of each time point were stimulated for either 24 or 48 h. Protein levels and mRNA expression of markers of inflammation is measured in PBMC's and supernatant of stimulated cells.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date January 27, 2021
Est. primary completion date January 27, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - healthy, normal weight, Exclusion Criteria: - food intolerances, food allergies, chronic inflammatory diseases, metabolic diseases, viral or bacterial infections within the last 3 weeks of inclusion, intake of immunosupressive medication

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Dietary Intervention 1: Placebo
Participants receive a study drink supplemented with a placebo for 5 days
Dietary Intervention 2: Xanthohumol and Iso-alpha acids
Participants receive a study drink supplemented with xanthohumol, Iso-alpha acids or a combination of both for 5 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 parameters of immune response Parameters of immune response are measured in cell culture supernatant of stimulated cells 5 days
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