Clinical trial NCT05706350: Plant Stanol Esters and Influenza Vaccination
Official title: Evaluating the Effect of Different Daily Plant Stanol Ester Intakes on the Vaccination Response to an Influenza Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immune Response
Keywords: Plant Stanols
Immune system
Influenza vaccination
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Raisio Nutrition Ltd.
First posted: 2023-01-31
Enrollment: 137
Sex: ALL
Minimum age (years): 59
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 women
* Aged 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/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 Criteria:

* Already received influenza vaccination in 2022
* Already had influenza in 2022
* Allergy to an ingredient of the chews
* Having donated blood within one month prior to the start of the study, or planning to donate blood during the study
* Excessive alcohol use (\>20 consumptions per week)
* Regular use of soft and/or hard drugs

Primary outcomes:
measure: Vaccine specific IgM antibody titer
timeFrame: Maximal change from T=0 (change T=0 to T=3 weeks or T=4 weeks)
Secondary outcomes:
measure: Vaccine specific IgG antibody titer
timeFrame: T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
measure: Immune parameters (1)
timeFrame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
measure: Immune parameters (2)
timeFrame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
measure: Leukocyte count
timeFrame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
measure: Leukocyte differential count
timeFrame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
measure: Fasted metabolism (1)
timeFrame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
measure: Fasted metabolism (2)
timeFrame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
measure: Fasted metabolism (3)
timeFrame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
measure: Anthropometry (1)
timeFrame: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
measure: Anthropometry (2)
timeFrame: Day - 1 (start study)
measure: Anthropometry (3)
timeFrame: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
measure: Anthropometry (4)
timeFrame: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
measure: Anthropometry (5)
timeFrame: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
measure: Diet
timeFrame: Day - 1 (start study), T=4 weeks after vaccination (end of study)
measure: Liver elastography
timeFrame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
measure: Liver fat content
timeFrame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
measure: Diary outcomes (1)
timeFrame: Day - 1 (start study), T=4 weeks after vaccination (end of study)
measure: Diary outcomes (2)
timeFrame: Day - 1 (start study), T=4 weeks after vaccination (end of study)
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
References: