Hop Compounds on the Immune System in Overweight People

NCT ID: NCT06745102

Last Updated: 2025-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-12-30

Brief Summary

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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

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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.

Conditions

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Inflammatory Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Xanthohumol

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

Group Type EXPERIMENTAL

Xanthohumol

Intervention Type DIETARY_SUPPLEMENT

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

Iso-alpha Acids

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

Group Type EXPERIMENTAL

Iso-alpha Acids

Intervention Type DIETARY_SUPPLEMENT

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

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)

Group Type EXPERIMENTAL

Xanthohumol + Iso-alpha Acids

Intervention Type DIETARY_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)

Interventions

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Xanthohumol

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

Intervention Type DIETARY_SUPPLEMENT

Iso-alpha Acids

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

Intervention Type 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)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Ina Bergheim

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Vienna

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Facility Contacts

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Ina Bergheim, Prof. Dr.

Role: primary

+43-1-4277-54981

Other Identifiers

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UVienna24

Identifier Type: -

Identifier Source: org_study_id

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