Inflammatory ResponseHINCT04847193
Hop Compounds and Immune System
A study testing Dietary Intervention 2: Xanthohumol and Iso-alpha acids in people with Inflammatory Response, run by University of Vienna at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Response
- What is being tested?
- Dietary Intervention 2: Xanthohumol and Iso-alpha acids
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteAustria
- Study dates
- 13 Jun 2019to 27 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy, normal weight,
Who cannot join
- food intolerances, food allergies, chronic inflammatory diseases, metabolic diseases, viral or bacterial infections within the last 3 weeks of inclusion, intake of immunosupressive medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Iso-alpha-Acids and Xanthohumol on Inflammatory Processes in Human
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.
Read the 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 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
- Inflammatory Response
- Being tested
- Dietary Intervention 1: Placebo, Dietary Intervention 2: Xanthohumol and Iso-alpha acids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Intervention 1: PlaceboOther
Participants receive a study drink supplemented with a placebo for 5 days
Dietary Intervention 2: Xanthohumol and Iso-alpha acidsOther
Participants receive a study drink supplemented with xanthohumol, Iso-alpha acids or a combination of both for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | Participants receive a study drink supplemented with a placebo over a time period of 5 days. Receives: Other: Dietary Intervention 1: Placebo |
| Xanthohumol | Experimental | Participants receive a study drink supplemented with Xanthohumol over a time period of 5 days. Receives: Other: Dietary Intervention 2: Xanthohumol and Iso-alpha acids |
| Iso-alpha acids | Experimental | Participants receive a study drink supplemented with Iso-alpha acids over a time period of 5 days. Receives: Other: Dietary Intervention 2: Xanthohumol and Iso-alpha acids |
| Xanthohumol/Iso-alpha acids | Experimental | Participants receive a study drink supplemented with a combination of Xanthohumol and Iso-alpha acids over a time period of 5 days. Receives: Other: Dietary Intervention 2: Xanthohumol and Iso-alpha acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in parameters of immune response
Parameters of immune response are measured in cell culture supernatant of stimulated cells
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start13 Jun 2019
- Primary completion27 Jan 2021
- Study completion27 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inflammatory ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Ina Bergheim, University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847193
- Sponsor's protocol ID
- UVienna19a
- Acronym
- HI
- Status last verified
- Mar 2022
- First submitted
- 16 Mar 2021
- Last updated
- 22 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36293555Jung 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.
PubMed 35857130
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Iso-alpha-Acids and Xanthohumol on Inflammatory Processes in Human
- ClinicalTrials.gov ID
- NCT04847193
- Acronym / sponsor ID
- HI / UVienna19a
- Conditions
- Inflammatory Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ViennaUniversity, hospital or other
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- 27 Jan 2021 (actual)
- Study completion
- 27 Jan 2021 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Other: Dietary Intervention 1: PlaceboParticipants receive a study drink supplemented with a placebo over a time period of 5 days. |
| Xanthohumol | Experimental | Other: Dietary Intervention 2: Xanthohumol and Iso-alpha acidsParticipants receive a study drink supplemented with Xanthohumol over a time period of 5 days. |
| Iso-alpha acids | Experimental | Other: Dietary Intervention 2: Xanthohumol and Iso-alpha acidsParticipants receive a study drink supplemented with Iso-alpha acids over a time period of 5 days. |
| Xanthohumol/Iso-alpha acids | Experimental | Other: Dietary Intervention 2: Xanthohumol and Iso-alpha acidsParticipants receive a study drink supplemented with a combination of Xanthohumol and Iso-alpha acids over a time period of 5 days. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy, normal weight,
Key exclusion criteria (1 listed)
- food intolerances, food allergies, chronic inflammatory diseases, metabolic diseases, viral or bacterial infections within the last 3 weeks of inclusion, intake of immunosupressive medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary Intervention 1: PlaceboParticipants receive a study drink supplemented with a placebo for 5 days | Other | Placebo |
| Dietary Intervention 2: Xanthohumol and Iso-alpha acidsParticipants receive a study drink supplemented with xanthohumol, Iso-alpha acids or a combination of both for 5 days | Other | Iso-alpha acids, Xanthohumol, Xanthohumol/Iso-alpha acids |
Primary outcome
Changes in parameters of immune response
Time frame: 5 days
Parameters of immune response are measured in cell culture supernatant of stimulated cells
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Derived from this study: PubMed 36293555Jung 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.
- Derived from this study: PubMed 35857130Jung 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.
- Individual participant dataSharing planned: No
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Intervention 2: Xanthohumol and Iso-alpha acids in people with Inflammatory Response, run by University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in parameters of immune response (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04847193, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.