Hop Compounds on the Immune System in Overweight People (ÜG)

Effect of Iso-alpha Acids and Xanthohumol on the Human Immune System in Overweight People With the Onset of Metabolic Diseases

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Response
• Intervention / Treatment: Dietary supplement: Xanthohumol; Dietary supplement: Iso-alpha Acids; Dietary supplement: Xanthohumol + Iso-alpha Acids

Detailed Description

The aim of the present study is to investigate whether the oral intake of Xanthohumol and Iso-alpha Acids has different protective effects on the immune response of isolated blood cells from overweight people with people with incipient metabolic diseases, what the time course of the effect is and whether the levels of the substances differ from normal-weight individuals.

After taking a fasting blood sample, the study participants receive one of the study drinks and a light breakfast. Both should be consumed within 15 minutes. Further blood samples are taken 1, 2, 3, 4 and 6 hours after the drinks have been consumed. To assess the effect of Xanthohumol and Iso-alpha Acids or a combination of both, clinical parameters, blood lipids, blood glucose, uric acid and inflammatory markers will be determined. Furthermore, blood cells, isolated from blood samples of each time point, will be stimulated for measuring inflammatory markers.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • University of Vienna
    • Contact: Ina Bergheim, Prof. Dr.; Phone Number: +43-1-4277-54981; Email: ina.bergheim@univie.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Xanthohumol; Participants receive a study drink supplemented with Xanthohumol (0 mg = Placebo or 0.75 mg soluble Xanthohumol)	Dietary supplement: Xanthohumol; Participants receive a study drink supplemented with Xanthohumol (0 mg = Placebo or 0.75 mg soluble Xanthohumol)
Experimental: Iso-alpha Acids; Participants receive a study drink supplemented with Iso-alpha Acids (0 mg = Placebo or 45 mg Iso-alpha Acids)	Dietary supplement: Iso-alpha Acids; Participants receive a study drink supplemented with Iso-alpha Acids (0 mg = Placebo or 45 mg Iso-alpha Acids)
Experimental: Xanthohumol + Iso-alpha Acids; 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; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): December 20, 2024

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 10, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Antineoplastic Agents; Physiological Effects of Drugs; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Xanthohumol
• Other Study ID Numbers: UVienna24

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
• product manufactured in and exported from the U.S.: No