Food SensitivityNCT04983420
Effects of Different Polyphenol-containing Beverages on the Immune System and on Muscular Growth Factors
A study testing non-alcoholic Pilsner, non-alcoholic wheat beer and apple spritzer in people with Food Sensitivity, run by Balgrist University Hospital at 1 site in Switzerland.
Trial summary
In this research project, the effect of different polyphenol-containing beverages with varying alcohol content of < 0.4 vol% on immune function as well as muscular growth factors will be investigated Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Sensitivity
- What is being tested?
- non-alcoholic Pilsner, non-alcoholic wheat beer and apple spritzer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2021to 31 May 2023
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Age 20 - 60 years
- Written informed consent
Who cannot join
- severe gastrointestinal disease or known malabsorption
- use of proton pump inhibitors
- malignancies
- rheumatoid diseases
- metabolic syndrome
- acute or chronic infections or inflammatory diseases
Show all 12Show fewer
- use of medications or supplements to interfere with immune function
- alcohol and/or drug abuse or addiction
- dependent relationship with the project manager or his or her employees
- pregnancy or breastfeeding
- chronic illness or regular use of medication (except hormonal contraception)
- smoker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Different Polyphenol-containing Beverages on the Immune System and on Muscular Growth Factors - a Pilot Study
In this research project, the effect of different polyphenol-containing beverages with varying alcohol content of < 0.4 vol% on immune function as well as muscular growth factors will be investigated
- Conditions
- Food Sensitivity
- Being tested
- non-alcoholic Pilsner, non-alcoholic wheat beer, apple spritzer, lemonade
- Medical subject headings
- Food Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-alcoholic PilsnerOther
intake of 1 L non-alcoholic Pilsner per day for 2 weeks
non-alcoholic wheat beerOther
intake of 1 L non-alcoholic wheat beer per day for 2 weeks
apple spritzerOther
intake of 1 L apple spritzer per day for 2 weeks
lemonadeOther
intake of 1 L lemonade per day for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| non-alcoholic Pilsner | Experimental | 1 L non-alcoholic Pilsner per day for 2 weeks Receives: Other: non-alcoholic Pilsner |
| non-alcoholic wheat beer | Experimental | 1 L non-alcoholic wheat beer per day for 2 weeks Receives: Other: non-alcoholic wheat beer |
| apple spritzer | Active comparator | 1 L apple spritzer per day for 2 weeks Receives: Other: apple spritzer |
| lemonade | Placebo comparator | 1 L lemonade per day for 2 weeks Receives: Other: lemonade |
What is being measured
The primary outcome is the main question the study is designed to answer.
white blood cells
white blood cell count
Measured: before beverage intake
white blood cells
white blood cell count
Measured: 60 minutes after intake
white blood cells
white blood cell count
Measured: 120 minutes after intake
inflammatory markers in the blood
IL-6, TNF- α, hs-CRP
Measured: before beverage intake
inflammatory markers in the blood
IL-6, TNF- α, hs-CRP
Measured: 60 minutes after intake
inflammatory markers in the blood
IL-6, TNF- α, hs-CRP
Measured: 120 minutes after intake
blood alcohol
blood alcohol level
Measured: before beverage intake
blood alcohol
blood alcohol level
Measured: 60 minutes after intake
blood alcohol
blood alcohol level
Measured: 120 minutes after intake
white blood cells
white blood cell count
Measured: after 14 days of daily intake
inflammatory markers in the blood
IL-6, TNF- α, hs-CRP
Measured: after 14 days of daily intake
blood alcohol
blood alcohol level
Measured: after 14 days of daily intake
polyphenol in the urine
polyphenol level in the urine
Measured: before beverage intake
polyphenol in the urine
polyphenol level in the urine
Measured: 120 minutes after intake
polyphenol in the urine
polyphenol level in the urine
Measured: after 14 days of daily intake
Secondary outcomes (4)
dietary habit
3 day food diary
Measured: before beverage intake and day 12-14 of beverage intake
dietary habit
3 day food diary
Measured: day 12-14 of beverage intake
physical activity
Global Physical Activity Questionnaire (allows to calculate metabolic equivalents to express the intensity of physical activities
Measured: before beverage intake
physical activity
Global Physical Activity Questionnaire (allows to calculate metabolic equivalents to express the intensity of physical activities
Measured: day 14 of beverage intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start1 Jan 2021
- Primary completion30 Sep 2021
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food SensitivityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johannes Scherr, Prof, Principal investigator, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983420
- Sponsor's protocol ID
- Polyphenol
- Status last verified
- Aug 2023
- First submitted
- 6 May 2021
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Polyphenol-containing Beverages on the Immune System and on Muscular Growth Factors - a Pilot Study
- ClinicalTrials.gov ID
- NCT04983420
- Acronym / sponsor ID
- Polyphenol
- Conditions
- Food Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 30 Jul 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.
In this research project, the effect of different polyphenol-containing beverages with varying alcohol content of < 0.4 vol% on immune function as well as muscular growth factors will be investigated
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| non-alcoholic Pilsner | Experimental | Other: non-alcoholic Pilsner1 L non-alcoholic Pilsner per day for 2 weeks |
| non-alcoholic wheat beer | Experimental | Other: non-alcoholic wheat beer1 L non-alcoholic wheat beer per day for 2 weeks |
| apple spritzer | Active comparator | Other: apple spritzer1 L apple spritzer per day for 2 weeks |
| lemonade | Placebo comparator | Other: lemonade1 L lemonade per day for 2 weeks |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy
- Age 20 - 60 years
- Written informed consent
Key exclusion criteria (12 listed)
- severe gastrointestinal disease or known malabsorption
- use of proton pump inhibitors
- malignancies
- rheumatoid diseases
- metabolic syndrome
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 |
|---|---|---|
| non-alcoholic Pilsnerintake of 1 L non-alcoholic Pilsner per day for 2 weeks | Other | non-alcoholic Pilsner |
| non-alcoholic wheat beerintake of 1 L non-alcoholic wheat beer per day for 2 weeks | Other | non-alcoholic wheat beer |
| apple spritzerintake of 1 L apple spritzer per day for 2 weeks | Other | apple spritzer |
| lemonadeintake of 1 L lemonade per day for 2 weeks | Other | lemonade |
Primary outcome
white blood cells
Time frame: before beverage intake
white blood cell count
white blood cells
Time frame: 60 minutes after intake
white blood cell count
white blood cells
Time frame: 120 minutes after intake
white blood cell count
inflammatory markers in the blood
Time frame: before beverage intake
IL-6, TNF- α, hs-CRP
inflammatory markers in the blood
Time frame: 60 minutes after intake
IL-6, TNF- α, hs-CRP
inflammatory markers in the blood
Time frame: 120 minutes after intake
IL-6, TNF- α, hs-CRP
blood alcohol
Time frame: before beverage intake
blood alcohol level
blood alcohol
Time frame: 60 minutes after intake
blood alcohol level
blood alcohol
Time frame: 120 minutes after intake
blood alcohol level
white blood cells
Time frame: after 14 days of daily intake
white blood cell count
inflammatory markers in the blood
Time frame: after 14 days of daily intake
IL-6, TNF- α, hs-CRP
blood alcohol
Time frame: after 14 days of daily intake
blood alcohol level
polyphenol in the urine
Time frame: before beverage intake
polyphenol level in the urine
polyphenol in the urine
Time frame: 120 minutes after intake
polyphenol level in the urine
polyphenol in the urine
Time frame: after 14 days of daily intake
polyphenol level in the urine
4 secondary outcomes
dietary habit
Time frame: before beverage intake and day 12-14 of beverage intake
dietary habit
Time frame: day 12-14 of beverage intake
physical activity
Time frame: before beverage intake
physical activity
Time frame: day 14 of beverage intake
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 15 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Johannes Scherr, Prof principal investigator
Balgrist University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-alcoholic Pilsner, non-alcoholic wheat beer and apple spritzer in people with Food Sensitivity, run by Balgrist University Hospital at 1 site in Switzerland.
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 3 inclusion and 12 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 15 Aug 2023. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?
white blood cells (time frame: before beverage intake). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2023.