Hop Compounds on the Immune System in Overweight People (ÜG)

University of Vienna

Status: Enrolling

Conditions: Inflammatory Response

Treatments: Dietary Supplement: Xanthohumol + Iso-alpha Acids; Dietary Supplement: Iso-alpha Acids; Dietary Supplement: Xanthohumol

Study type: Interventional

Funder types: Other

Identifiers

NCT06745102

UVienna24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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24 participants in 3 patient groups

Xanthohumol

Experimental group

Description:

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

Treatment:

Dietary Supplement: Xanthohumol

Iso-alpha Acids

Experimental group

Description:

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

Treatment:

Dietary Supplement: Iso-alpha Acids

Xanthohumol + Iso-alpha Acids

Experimental group

Description:

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)

Treatment:

Dietary Supplement: Xanthohumol + Iso-alpha Acids