Hop Compounds and Immune System (HI)

March 21, 2022 updated by: Prof. Dr. Ina Bergheim, University of Vienna

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

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 Locations

  • Austria
      • Vienna, Austria, 1090
        • University of Vienna

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

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Placebo
Participants receive a study drink supplemented with a placebo over a time period of 5 days.
Other: Dietary Intervention 1: Placebo
Participants receive a study drink supplemented with a placebo for 5 days
Experimental: Xanthohumol
Participants receive a study drink supplemented with Xanthohumol over a time period of 5 days.
Other: 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
Experimental: Iso-alpha acids
Participants receive a study drink supplemented with Iso-alpha acids over a time period of 5 days.
Other: 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
Experimental: Xanthohumol/Iso-alpha acids
Participants receive a study drink supplemented with a combination of Xanthohumol and Iso-alpha acids over a time period of 5 days.
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in parameters of immune response
Time Frame: 5 days
Parameters of immune response are measured in cell culture supernatant of stimulated cells
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 13, 2019

Primary Completion (Actual)

January 27, 2021

Study Completion (Actual)

January 27, 2021

Study Registration Dates

First Submitted

March 16, 2021

First Submitted That Met QC Criteria

April 13, 2021

First Posted (Actual)

April 19, 2021

Study Record Updates

Last Update Posted (Actual)

March 22, 2022

Last Update Submitted That Met QC Criteria

March 21, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UVienna19a

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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