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Completed

NCT Number: NCT04983420

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

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

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Balgrist University Hospital

Zurich, 8008, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

non-alcoholic Pilsner

Other

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

non-alcoholic wheat beer

Other

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

apple spritzer

Other

intake of 1 L apple spritzer per day for 2 weeks

lemonade

Other

intake of 1 L lemonade per day for 2 weeks

Primary outcomes

  1. white blood cells

    Time frame: before beverage intake

    white blood cell count

  2. white blood cells

    Time frame: 60 minutes after intake

    white blood cell count

  3. white blood cells

    Time frame: 120 minutes after intake

    white blood cell count

  4. inflammatory markers in the blood

    Time frame: before beverage intake

    IL-6, TNF- α, hs-CRP

  5. inflammatory markers in the blood

    Time frame: 60 minutes after intake

    IL-6, TNF- α, hs-CRP

  6. inflammatory markers in the blood

    Time frame: 120 minutes after intake

    IL-6, TNF- α, hs-CRP

  7. blood alcohol

    Time frame: before beverage intake

    blood alcohol level

  8. blood alcohol

    Time frame: 60 minutes after intake

    blood alcohol level

  9. blood alcohol

    Time frame: 120 minutes after intake

    blood alcohol level

  10. white blood cells

    Time frame: after 14 days of daily intake

    white blood cell count

  11. inflammatory markers in the blood

    Time frame: after 14 days of daily intake

    IL-6, TNF- α, hs-CRP

  12. blood alcohol

    Time frame: after 14 days of daily intake

    blood alcohol level

  13. polyphenol in the urine

    Time frame: before beverage intake

    polyphenol level in the urine

  14. polyphenol in the urine

    Time frame: 120 minutes after intake

    polyphenol level in the urine

  15. polyphenol in the urine

    Time frame: after 14 days of daily intake

    polyphenol level in the urine

Secondary outcomes

  1. dietary habit

    Time frame: before beverage intake and day 12-14 of beverage intake

    3 day food diary

  2. dietary habit

    Time frame: day 12-14 of beverage intake

    3 day food diary

  3. physical activity

    Time frame: before beverage intake

    Global Physical Activity Questionnaire (allows to calculate metabolic equivalents to express the intensity of physical activities

  4. physical activity

    Time frame: day 14 of beverage intake

    Global Physical Activity Questionnaire (allows to calculate metabolic equivalents to express the intensity of physical activities

Sponsors and collaborators

Lead sponsor

Balgrist University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2023
First posted
Jul 30, 2021
Registry last updated
Aug 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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