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Completed
NCT05706350
Plant Stanol Esters and Influenza Vaccination
Conditions: Immune Response
Sex: All
Ages: 59 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 137
Sponsor: Maastricht University Medical Center
Location: Netherlands
Summary
Plant stanols are known to lower low-density lipoprotein cholesterol (LDL-C).
However, recent studies have suggested that these compounds also beneficially influence the immune system, e.g.
increasing vaccine-specific antibody titers.
BMI and age have previously been negatively associated to vaccination responses.
If plant stanols indeed have beneficial effects on the immune system, people with overweight or obesity and higher age might benefit from consuming plant stanols prior to receiving the influenza vaccination.
Eligibility Criteria
Inclusion Criteria:Men and womenAged 60 years or older (or 59, but turning 60 years during influenza season 2022/2023 (in line with RIVM guidelines))BMI between 20 and 35 kg/m2Currently 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 constantExclusion Criteria:Already received influenza vaccination in 2022Already had influenza in 2022Allergy to an ingredient of the chewsHaving donated blood within one month prior to the start of the study, or planning to donate blood during the studyExcessive alcohol use (>20 consumptions per week)Regular use of soft and/or hard drugs
Source: ClinicalTrials.gov (NCT05706350). StuddyBuddy aggregates publicly available trial information.
