NCT06745102

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

April 15, 2025

Status Verified

April 1, 2025

Enrollment Period

1.7 years

First QC Date

December 17, 2024

Last Update Submit

April 10, 2025

Conditions

Inflammatory Response

Outcome Measures

Primary Outcomes (3)

  • Changes in parameters of immune response

    Changes in concentration of interleukin 6 (ng/ml) in cell culture supernatant of stimulated cells

    6 hours

  • Changes in parameters of immune response

    Changes in concentrations of interleukin 1 beta (ng/ml) in cell culture supernatant of stimulated cells

    6 hours

  • Changes in parameters of immune response

    Changes in concentration of tumor necrosis factor alpha (ng/ml) in cell culture supernatant of stimulated cells

    6 hours

Study Arms (3)

Xanthohumol

EXPERIMENTAL

Participants receive a study drink supplemented with Xanthohumol (0 mg = Placebo or 0.75 mg soluble Xanthohumol)

Dietary Supplement: Xanthohumol

Iso-alpha Acids

EXPERIMENTAL

Participants receive a study drink supplemented with Iso-alpha Acids (0 mg = Placebo or 45 mg Iso-alpha Acids)

Dietary Supplement: Iso-alpha Acids

Xanthohumol + Iso-alpha Acids

EXPERIMENTAL

Participants receive a study drink supplemented with Xanthohumol + Iso-alpha Acids (0 mg = Placebo or 0.75 mg + 45 mg soluble Xanthohumol + Iso-alpha Acids)

Dietary Supplement: Xanthohumol + Iso-alpha Acids

Interventions

XanthohumolDIETARY_SUPPLEMENT

Participants receive a study drink supplemented with Xanthohumol (0 mg = Placebo or 0.75 mg soluble Xanthohumol)

Xanthohumol
Iso-alpha AcidsDIETARY_SUPPLEMENT

Participants receive a study drink supplemented with Iso-alpha Acids (0 mg = Placebo or 45 mg Iso-alpha Acids)

Iso-alpha Acids
Xanthohumol + Iso-alpha AcidsDIETARY_SUPPLEMENT

Participants receive a study drink supplemented with Xanthohumol and Iso-alpha Acids (0 mg = Placebo or 0.75 mg + 45 mg soluble Xanthohumol + Iso-alpha Acids)

Xanthohumol + Iso-alpha Acids

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI 25 - 29,9 kg/m²
  • as well as one or more of the following incipient metabolic diseases:
  • pre-diabetes (fasting blood glucose 100-125 mg/dL),
  • fatty liver (grade 1-3),
  • high-normal blood pressure to mild hypertension (grade 1, systolic 140-159 mmHg)

You may not qualify if:

  • History of diseases that could falsify the study results
  • inflammatory bowel diseases
  • malignant diseases of the gastrointestinal tract
  • food allergies
  • malabsorption
  • kidney or liver disease (except simple fatty liver)
  • symptomatic heart failure
  • Taking medication to treat these diseases
  • Consumption of special diets (e.g. vegan, gluten-free)
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Interventions

xanthohumol

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

December 17, 2024

First Posted

December 20, 2024

Study Start

February 1, 2024

Primary Completion

October 1, 2025

Study Completion

December 30, 2025

Last Updated

April 15, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)