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

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

Study Overview

• Status: Completed
• Conditions: Food Sensitivity
• Intervention / Treatment: Other: non-alcoholic Pilsner; Other: non-alcoholic wheat beer; Other: apple spritzer; Other: lemonade

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8008
    • Balgrist University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Balgrist University Hospital
• Investigators: Principal Investigator: Johannes Scherr, Prof, Balgrist University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: May 6, 2021
• First Submitted That Met QC Criteria: July 20, 2021
• First Posted (Actual): July 30, 2021

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 14, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: Polyphenol

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No