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Recruiting NCT06286644

Hop Compounds on the Immune System (VH)

No phase Interventional Inflammatory Response

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Xanthohumol, Iso-alpha-Acids, Xanthohumol + Iso-alpha-Acids.
Who it may be relevant to
Registry conditions: Inflammatory Response. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of Iso-alpha Acids and Xanthohumol on the Human Immune System

Overview

The aim of the present study is to determine the effect of Iso-alpha-Acids and Xanthohumol from hops on the immune response of healthy participants over a timeframe of 6 hours.

Detailed description

In this placebo-controlled crossover study a study drink enriched with either a placebo, Xanthohumol, Iso-alpha Acids or a combination of latter is given to the participants. A washout phase before intervention and between each intervention is introduced. On day one of each intervention blood is drawn in fasted state from each participant. Subsequently the study drink combined with a standardized breakfast is given to the participants followed by blood draws 1, 2, 3, 4 and 6 hours after the consumption of the study drink. 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.

Interventions

  • Dietary supplement Xanthohumol
    Participants receive a study drink supplemented with Xanthohumol (0 mg = Placebo, 0,125 mg, 0,375 mg or 0,75 mg soluble Xanthohumol)
  • Dietary supplement Iso-alpha-Acids
    Participants receive a study drink supplemented with Iso-alpha-Acids (0 mg = Placebo, 15 mg, 45 mg or 90 mg Iso-alpha-Acids)
  • Dietary supplement Xanthohumol + Iso-alpha-Acids
    Participants receive a study drink supplemented with Xanthohumol + Iso-alpha-Acids (0 mg = Placebo, 0,125 mg + 15 mg , 0,375 mg + 45 mg or 0,75 mg + 90 mg soluble Xanthohumol + Iso-alpha-Acids)

Primary outcome measures

  • Changes in parameters of immune response [Time frame: 6 hours]
  • Changes in parameters of immune response [Time frame: 6 hours]

Eligibility criteria

Inclusion criteria

  • healthy
  • BMI: >18,5 kg/m² or <30 kg/m²

Exclusion criteria

  • food intolerances
  • food allergies
  • chronic inflammatory diseases
  • metabolic diseases
  • viral or bacterial infections within the last 3 weeks of inclusion
  • intake of immunosuppressive medication

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Basic science

Study locations

Austria · 1 center
  • University of Vienna — Vienna

Identifiers

NCT: NCT06286644 · UVienna23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗