Effects of Different Polyphenol-containing Beverages on the Immune System and on Muscular Growth Factors
Primary Purpose
Food Sensitivity
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
non-alcoholic Pilsner
non-alcoholic wheat beer
apple spritzer
lemonade
Sponsored by
About this trial
This is an interventional other trial for Food Sensitivity
Eligibility Criteria
Inclusion Criteria:
- Healthy
- Age 20 - 60 years
- Written informed consent
Exclusion Criteria:
- 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
Sites / Locations
- Balgrist University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
non-alcoholic Pilsner
non-alcoholic wheat beer
apple spritzer
lemonade
Arm Description
1 L non-alcoholic Pilsner per day for 2 weeks
1 L non-alcoholic wheat beer per day for 2 weeks
1 L apple spritzer per day for 2 weeks
1 L lemonade per day for 2 weeks
Outcomes
Primary Outcome Measures
white blood cells
white blood cell count
white blood cells
white blood cell count
white blood cells
white blood cell count
inflammatory markers in the blood
IL-6, TNF- α, hs-CRP
inflammatory markers in the blood
IL-6, TNF- α, hs-CRP
inflammatory markers in the blood
IL-6, TNF- α, hs-CRP
blood alcohol
blood alcohol level
blood alcohol
blood alcohol level
blood alcohol
blood alcohol level
white blood cells
white blood cell count
inflammatory markers in the blood
IL-6, TNF- α, hs-CRP
blood alcohol
blood alcohol level
polyphenol in the urine
polyphenol level in the urine
polyphenol in the urine
polyphenol level in the urine
polyphenol in the urine
polyphenol level in the urine
Secondary Outcome Measures
dietary habit
3 day food diary
dietary habit
3 day food diary
physical activity
Global Physical Activity Questionnaire (allows to calculate metabolic equivalents to express the intensity of physical activities
physical activity
Global Physical Activity Questionnaire (allows to calculate metabolic equivalents to express the intensity of physical activities
Full Information
NCT ID
NCT04983420
First Posted
May 6, 2021
Last Updated
August 14, 2023
Sponsor
Balgrist University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04983420
Brief Title
Effects of Different Polyphenol-containing Beverages on the Immune System and on Muscular Growth Factors
Official Title
Effects of Different Polyphenol-containing Beverages on the Immune System and on Muscular Growth Factors - a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
May 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Balgrist University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Sensitivity
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
non-alcoholic Pilsner
Arm Type
Experimental
Arm Description
1 L non-alcoholic Pilsner per day for 2 weeks
Arm Title
non-alcoholic wheat beer
Arm Type
Experimental
Arm Description
1 L non-alcoholic wheat beer per day for 2 weeks
Arm Title
apple spritzer
Arm Type
Active Comparator
Arm Description
1 L apple spritzer per day for 2 weeks
Arm Title
lemonade
Arm Type
Placebo Comparator
Arm Description
1 L lemonade per day for 2 weeks
Intervention Type
Other
Intervention Name(s)
non-alcoholic Pilsner
Intervention Description
intake of 1 L non-alcoholic Pilsner per day for 2 weeks
Intervention Type
Other
Intervention Name(s)
non-alcoholic wheat beer
Intervention Description
intake of 1 L non-alcoholic wheat beer per day for 2 weeks
Intervention Type
Other
Intervention Name(s)
apple spritzer
Intervention Description
intake of 1 L apple spritzer per day for 2 weeks
Intervention Type
Other
Intervention Name(s)
lemonade
Intervention Description
intake of 1 L lemonade per day for 2 weeks
Primary Outcome Measure Information:
Title
white blood cells
Description
white blood cell count
Time Frame
before beverage intake
Title
white blood cells
Description
white blood cell count
Time Frame
60 minutes after intake
Title
white blood cells
Description
white blood cell count
Time Frame
120 minutes after intake
Title
inflammatory markers in the blood
Description
IL-6, TNF- α, hs-CRP
Time Frame
before beverage intake
Title
inflammatory markers in the blood
Description
IL-6, TNF- α, hs-CRP
Time Frame
60 minutes after intake
Title
inflammatory markers in the blood
Description
IL-6, TNF- α, hs-CRP
Time Frame
120 minutes after intake
Title
blood alcohol
Description
blood alcohol level
Time Frame
before beverage intake
Title
blood alcohol
Description
blood alcohol level
Time Frame
60 minutes after intake
Title
blood alcohol
Description
blood alcohol level
Time Frame
120 minutes after intake
Title
white blood cells
Description
white blood cell count
Time Frame
after 14 days of daily intake
Title
inflammatory markers in the blood
Description
IL-6, TNF- α, hs-CRP
Time Frame
after 14 days of daily intake
Title
blood alcohol
Description
blood alcohol level
Time Frame
after 14 days of daily intake
Title
polyphenol in the urine
Description
polyphenol level in the urine
Time Frame
before beverage intake
Title
polyphenol in the urine
Description
polyphenol level in the urine
Time Frame
120 minutes after intake
Title
polyphenol in the urine
Description
polyphenol level in the urine
Time Frame
after 14 days of daily intake
Secondary Outcome Measure Information:
Title
dietary habit
Description
3 day food diary
Time Frame
before beverage intake and day 12-14 of beverage intake
Title
dietary habit
Description
3 day food diary
Time Frame
day 12-14 of beverage intake
Title
physical activity
Description
Global Physical Activity Questionnaire (allows to calculate metabolic equivalents to express the intensity of physical activities
Time Frame
before beverage intake
Title
physical activity
Description
Global Physical Activity Questionnaire (allows to calculate metabolic equivalents to express the intensity of physical activities
Time Frame
day 14 of beverage intake
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy
Age 20 - 60 years
Written informed consent
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johannes Scherr, Prof
Organizational Affiliation
Balgrist University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Balgrist University Hospital
City
Zurich
ZIP/Postal Code
8008
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Different Polyphenol-containing Beverages on the Immune System and on Muscular Growth Factors
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