Hop Compounds and Immune System

NCT ID: NCT04847193

Last Updated: 2022-03-22

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

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-13

Study Completion Date

2021-01-27

Brief Summary

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The aim of the present study is to determine the effect of Xanthohumol and Iso-alpha-acids from hops on the immune response of healthy participants.

Detailed Description

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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 following a second blood drawing one hour after the consumption of the study drink. On the last day of each intervention blood is taken from study participants in the same manner as on day one. To assess the effect of Xanthohumol and Iso-alpha acids or a combination of both, clinical chemical parameters e.g. ALT, AST, γ-GT, blood lipids (triglycerides, total cholesterol, HDL, LDL), blood glucose, uric acid and CRP are determined. Furthermore, PBMC's isolated from blood samples of each time point were stimulated for either 24 or 48 h. Protein levels and mRNA expression of markers of inflammation is measured in PBMC's and supernatant of stimulated cells.

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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Placebo

Participants receive a study drink supplemented with a placebo over a time period of 5 days.

Group Type EXPERIMENTAL

Dietary Intervention 1: Placebo

Intervention Type OTHER

Participants receive a study drink supplemented with a placebo for 5 days

Xanthohumol

Participants receive a study drink supplemented with Xanthohumol over a time period of 5 days.

Group Type EXPERIMENTAL

Dietary Intervention 2: Xanthohumol and Iso-alpha acids

Intervention Type OTHER

Participants receive a study drink supplemented with xanthohumol, Iso-alpha acids or a combination of both for 5 days

Iso-alpha acids

Participants receive a study drink supplemented with Iso-alpha acids over a time period of 5 days.

Group Type EXPERIMENTAL

Dietary Intervention 2: Xanthohumol and Iso-alpha acids

Intervention Type OTHER

Participants receive a study drink supplemented with xanthohumol, Iso-alpha acids or a combination of both for 5 days

Xanthohumol/Iso-alpha acids

Participants receive a study drink supplemented with a combination of Xanthohumol and Iso-alpha acids over a time period of 5 days.

Group Type EXPERIMENTAL

Dietary Intervention 2: Xanthohumol and Iso-alpha acids

Intervention Type OTHER

Participants receive a study drink supplemented with xanthohumol, Iso-alpha acids or a combination of both for 5 days

Interventions

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Dietary Intervention 1: Placebo

Participants receive a study drink supplemented with a placebo for 5 days

Intervention Type OTHER

Dietary Intervention 2: Xanthohumol and Iso-alpha acids

Participants receive a study drink supplemented with xanthohumol, Iso-alpha acids or a combination of both for 5 days

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* healthy, normal weight,

Exclusion Criteria

* food intolerances, food allergies, chronic inflammatory diseases, metabolic diseases, viral or bacterial infections within the last 3 weeks of inclusion, intake of immunosupressive medication
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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

Countries

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Austria

References

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Jung F, Staltner R, Baumann A, Burger K, Halilbasic E, Hellerbrand C, Bergheim I. A Xanthohumol-Rich Hop Extract Diminishes Endotoxin-Induced Activation of TLR4 Signaling in Human Peripheral Blood Mononuclear Cells: A Study in Healthy Women. Int J Mol Sci. 2022 Oct 21;23(20):12702. doi: 10.3390/ijms232012702.

Reference Type DERIVED
PMID: 36293555 (View on PubMed)

Jung F, Staltner R, Tahir A, Baumann A, Burger K, Halilbasic E, Hellerbrand C, Bergheim I. Oral intake of xanthohumol attenuates lipoteichoic acid-induced inflammatory response in human PBMCs. Eur J Nutr. 2022 Dec;61(8):4155-4166. doi: 10.1007/s00394-022-02964-2. Epub 2022 Jul 20.

Reference Type DERIVED
PMID: 35857130 (View on PubMed)

Other Identifiers

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UVienna19a

Identifier Type: -

Identifier Source: org_study_id

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