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Clinical Trials/NCT04847193
NCT04847193CompletedNot Applicable

Effect of Iso-alpha-Acids and Xanthohumol on Inflammatory Processes in Human

University of Vienna2 sites in 1 country15 target enrollmentStarted: June 13, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
15
Locations
2
Primary Endpoint
Changes in parameters of immune response

Study Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 30 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Changes in parameters of immune response

Time Frame: 5 days

Parameters of immune response are measured in cell culture supernatant of stimulated cells

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Prof. Dr. Ina Bergheim

Principal Investigator

University of Vienna

Study Sites (2)

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