Hop Compounds on the Immune System in Overweight People
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 — 75 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 →
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Official title
Effect of Iso-alpha Acids and Xanthohumol on the Human Immune System in Overweight People With the Onset of Metabolic Diseases
Overview
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.
Interventions
- Dietary supplement Xanthohumol
Participants receive a study drink supplemented with Xanthohumol (0 mg = Placebo or 0.75 mg soluble Xanthohumol) - Dietary supplement Iso-alpha Acids
Participants receive a study drink supplemented with Iso-alpha Acids (0 mg = Placebo or 45 mg 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)
Primary outcome measures
- Changes in parameters of immune response [Time frame: 6 hours]
- Changes in parameters of immune response [Time frame: 6 hours]
- Changes in parameters of immune response [Time frame: 6 hours]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
Austria · 1 center
- University of Vienna — Vienna
Identifiers
NCT: NCT06745102 · UVienna24