NCT04983420

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 30, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

August 15, 2023

Status Verified

August 1, 2023

Enrollment Period

9 months

First QC Date

May 6, 2021

Last Update Submit

August 14, 2023

Conditions

Food Sensitivity

Outcome Measures

Primary Outcomes (15)

  • white blood cells

    white blood cell count

    before beverage intake

  • white blood cells

    white blood cell count

    60 minutes after intake

  • white blood cells

    white blood cell count

    120 minutes after intake

  • inflammatory markers in the blood

    IL-6, TNF- α, hs-CRP

    before beverage intake

  • inflammatory markers in the blood

    IL-6, TNF- α, hs-CRP

    60 minutes after intake

  • inflammatory markers in the blood

    IL-6, TNF- α, hs-CRP

    120 minutes after intake

  • blood alcohol

    blood alcohol level

    before beverage intake

  • blood alcohol

    blood alcohol level

    60 minutes after intake

  • blood alcohol

    blood alcohol level

    120 minutes after intake

  • white blood cells

    white blood cell count

    after 14 days of daily intake

  • inflammatory markers in the blood

    IL-6, TNF- α, hs-CRP

    after 14 days of daily intake

  • blood alcohol

    blood alcohol level

    after 14 days of daily intake

  • polyphenol in the urine

    polyphenol level in the urine

    before beverage intake

  • polyphenol in the urine

    polyphenol level in the urine

    120 minutes after intake

  • polyphenol in the urine

    polyphenol level in the urine

    after 14 days of daily intake

Secondary Outcomes (4)

  • dietary habit

    before beverage intake and day 12-14 of beverage intake

  • dietary habit

    day 12-14 of beverage intake

  • physical activity

    before beverage intake

  • physical activity

    day 14 of beverage intake

Study Arms (4)

non-alcoholic Pilsner

EXPERIMENTAL

1 L non-alcoholic Pilsner per day for 2 weeks

Other: non-alcoholic Pilsner

non-alcoholic wheat beer

EXPERIMENTAL

1 L non-alcoholic wheat beer per day for 2 weeks

Other: non-alcoholic wheat beer

apple spritzer

ACTIVE COMPARATOR

1 L apple spritzer per day for 2 weeks

Other: apple spritzer

lemonade

PLACEBO COMPARATOR

1 L lemonade per day for 2 weeks

Other: lemonade

Interventions

non-alcoholic PilsnerOTHER

intake of 1 L non-alcoholic Pilsner per day for 2 weeks

non-alcoholic Pilsner
non-alcoholic wheat beerOTHER

intake of 1 L non-alcoholic wheat beer per day for 2 weeks

non-alcoholic wheat beer
apple spritzerOTHER

intake of 1 L apple spritzer per day for 2 weeks

apple spritzer
lemonadeOTHER

intake of 1 L lemonade per day for 2 weeks

lemonade

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Age 20 - 60 years
  • Written informed consent

You may not qualify if:

  • severe gastrointestinal disease or known malabsorption
  • use of proton pump inhibitors
  • malignancies
  • rheumatoid diseases
  • metabolic syndrome
  • acute or chronic infections or inflammatory diseases
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balgrist University Hospital

Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Food Intolerance

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Johannes Scherr, Prof

    Balgrist University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2021

First Posted

July 30, 2021

Study Start

January 1, 2021

Primary Completion

September 30, 2021

Study Completion

May 31, 2023

Last Updated

August 15, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)