Plant stanol esters and COVID-19 vaccination response

Phase 1

• Conditions: COVID-19 vaccination respons of people with BMI 27-35 kg/m2; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2021-001080-24-NL
• Lead Sponsor: Maastricht University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-18
• Last Update Posted: 21 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

•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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

Already received COVID-19 vaccination, already had a positive test for COVID-19 (all tests, e.g. PCR test or antibody test), allergy to an ingredient of the mini drinks, excessive alcohol use (>20 consumptions per week), regular use of drugs, blood donors that want to donate one month prior to or during the study, pregnant or breastfeeding women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified