Hop Compounds on the Immune System in Overweight People

Not Applicable

Recruiting

• Conditions: Inflammatory Response

• Registration Number: NCT06745102
• Lead Sponsor: University of Vienna

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.

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 Timeline

• Study Start: 2024-02-01
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-17
• Study First Posted: 2024-12-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-15
• Primary Completion: 2025-10-01
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Changes in parameters of immune response	6 hours	Changes in concentration of tumor necrosis factor alpha (ng/ml) in cell culture supernatant of stimulated cells

Trial Locations

Locations (1)

University of Vienna; 🇦🇹 Vienna, Austria