Status:
TERMINATED
Plant Stanol Esters and COVID-19 Vaccination Response
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
Raisio Nutrition Ltd.
Conditions:
Overweight and Obesity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Plant stanols are known to lower low-density lipoprotein cholesterol (LDL-C). However, studies have suggested that these compounds also beneficially influence the immune system, e.g. increasing vaccin...
Eligibility Criteria
Inclusion
- Men and women
- Aged 18 years or older
- BMI between 27 and 35 kg/m2
- Currently not using products containing plant sterols or stanols (products with a cholesterol lowering claim of Becel ProActiv, Benecol, Danacol, store brands)
- Willing to abstain from products containing plant sterols or stanols during the study (products with a cholesterol lowering claim of Becel ProActiv, Benecol, Danacol, store brands)
- Willing to keep the intake of fish oil and vitamin supplements constant
Exclusion
- Already received COVID-19 vaccination
- Already had a positive test for COVID-19 (this includes all types of tests, e.g. PCR tests or antibody tests)
- Allergy to an ingredient of the mini drinks
- Having donated blood within one month prior to the start of the study, or planning to donate blood during the study
- Pregnant women
- Breastfeeding women
- Excessive alcohol use (\>20 consumptions per week)
- Regular use of soft or hard drugs
Key Trial Info
Start Date :
April 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 11 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04844346
Start Date
April 22 2021
End Date
January 11 2022
Last Update
March 2 2022
Active Locations (1)
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1
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6229ER