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

Food Sensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04983420
• Other study ID #: Polyphenol
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: May 31, 2023

Study information

• Verified date: August 2023
• Source: Balgrist University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 31, 2023
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Food Sensitivity
• Hypersensitivity

Intervention

Other:
• non-alcoholic Pilsner
intake of 1 L non-alcoholic Pilsner per day for 2 weeks
• non-alcoholic wheat beer
intake of 1 L non-alcoholic wheat beer per day for 2 weeks
• apple spritzer
intake of 1 L apple spritzer per day for 2 weeks
• lemonade
intake of 1 L lemonade per day for 2 weeks

Locations

Country	Name	City	State
Switzerland	Balgrist University Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Balgrist University Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	white blood cells	white blood cell count	before beverage intake
Primary	white blood cells	white blood cell count	60 minutes after intake
Primary	white blood cells	white blood cell count	120 minutes after intake
Primary	inflammatory markers in the blood	IL-6, TNF- a, hs-CRP	before beverage intake
Primary	inflammatory markers in the blood	IL-6, TNF- a, hs-CRP	60 minutes after intake
Primary	inflammatory markers in the blood	IL-6, TNF- a, hs-CRP	120 minutes after intake
Primary	blood alcohol	blood alcohol level	before beverage intake
Primary	blood alcohol	blood alcohol level	60 minutes after intake
Primary	blood alcohol	blood alcohol level	120 minutes after intake
Primary	white blood cells	white blood cell count	after 14 days of daily intake
Primary	inflammatory markers in the blood	IL-6, TNF- a, hs-CRP	after 14 days of daily intake
Primary	blood alcohol	blood alcohol level	after 14 days of daily intake
Primary	polyphenol in the urine	polyphenol level in the urine	before beverage intake
Primary	polyphenol in the urine	polyphenol level in the urine	120 minutes after intake
Primary	polyphenol in the urine	polyphenol level in the urine	after 14 days of daily intake
Secondary	dietary habit	3 day food diary	before beverage intake and day 12-14 of beverage intake
Secondary	dietary habit	3 day food diary	day 12-14 of beverage intake
Secondary	physical activity	Global Physical Activity Questionnaire (allows to calculate metabolic equivalents to express the intensity of physical activities	before beverage intake
Secondary	physical activity	Global Physical Activity Questionnaire (allows to calculate metabolic equivalents to express the intensity of physical activities	day 14 of beverage intake