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NCT Number: NCT06745102

Hop Compounds on the Immune System in Overweight People

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xanthohumol

Dietary Supplement

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

Iso-alpha Acids

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

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)

Primary outcomes

  1. Changes in parameters of immune response

    Time frame: 6 hours

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

  2. Changes in parameters of immune response

    Time frame: 6 hours

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

  3. Changes in parameters of immune response

    Time frame: 6 hours

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

Sponsors and collaborators

Lead sponsor

University of Vienna

Other

Registry information

Official study title

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

Acronym: ÜG

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 20, 2024
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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