NCT04847193

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 19, 2021

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

1.6 years

First QC Date

March 16, 2021

Last Update Submit

March 21, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in parameters of immune response

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

    5 days

Study Arms (4)

Placebo

EXPERIMENTAL

Participants receive a study drink supplemented with a placebo over a time period of 5 days.

Other: Dietary Intervention 1: Placebo

Xanthohumol

EXPERIMENTAL

Participants receive a study drink supplemented with Xanthohumol over a time period of 5 days.

Other: Dietary Intervention 2: Xanthohumol and Iso-alpha acids

Iso-alpha acids

EXPERIMENTAL

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

Xanthohumol/Iso-alpha acids

EXPERIMENTAL

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

Interventions

Participants receive a study drink supplemented with a placebo for 5 days

Placebo

Participants receive a study drink supplemented with xanthohumol, Iso-alpha acids or a combination of both for 5 days

Iso-alpha acidsXanthohumolXanthohumol/Iso-alpha acids

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy, normal weight,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vienna

Vienna, 1090, Austria

Location

Related Publications (2)

  • Jung F, Staltner R, Baumann A, Burger K, Halilbasic E, Hellerbrand C, Bergheim I. A Xanthohumol-Rich Hop Extract Diminishes Endotoxin-Induced Activation of TLR4 Signaling in Human Peripheral Blood Mononuclear Cells: A Study in Healthy Women. Int J Mol Sci. 2022 Oct 21;23(20):12702. doi: 10.3390/ijms232012702.

  • Jung F, Staltner R, Tahir A, Baumann A, Burger K, Halilbasic E, Hellerbrand C, Bergheim I. Oral intake of xanthohumol attenuates lipoteichoic acid-induced inflammatory response in human PBMCs. Eur J Nutr. 2022 Dec;61(8):4155-4166. doi: 10.1007/s00394-022-02964-2. Epub 2022 Jul 20.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 16, 2021

First Posted

April 19, 2021

Study Start

June 13, 2019

Primary Completion

January 27, 2021

Study Completion

January 27, 2021

Last Updated

March 22, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations