Effects of Different Polyphenol-containing Beverages on the Immune System and on Muscular Growth Factors

Study Overview
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Brief Summary
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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

Official Title
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Effects of Different Polyphenol-containing Beverages on the Immune System and on Muscular Growth Factors - a Pilot Study

Conditions
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Food Sensitivity

Intervention / Treatment
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* Other: non-alcoholic Pilsner
* Other: non-alcoholic wheat beer
* Other: apple spritzer
* Other: lemonade


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: non-alcoholic Pilsner<br>1 L non-alcoholic Pilsner per day for 2 weeks | Other: non-alcoholic Pilsner<br>* intake of 1 L non-alcoholic Pilsner per day for 2 weeks<br>|
| Experimental: non-alcoholic wheat beer<br>1 L non-alcoholic wheat beer per day for 2 weeks | Other: non-alcoholic wheat beer<br>* intake of 1 L non-alcoholic wheat beer per day for 2 weeks<br>|
| Active Comparator: apple spritzer<br>1 L apple spritzer per day for 2 weeks | Other: apple spritzer<br>* intake of 1 L apple spritzer per day for 2 weeks<br>|
| Placebo Comparator: lemonade<br>1 L lemonade per day for 2 weeks | Other: lemonade<br>* intake of 1 L lemonade per day for 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dietary habit | 3 day food diary | before beverage intake and day 12-14 of beverage intake | 
| dietary habit | 3 day food diary | day 12-14 of beverage intake | 
| physical activity | Global Physical Activity Questionnaire (allows to calculate metabolic equivalents to express the intensity of physical activities | before beverage intake | 
| physical activity | Global Physical Activity Questionnaire (allows to calculate metabolic equivalents to express the intensity of physical activities | day 14 of beverage intake |