Plant Stanol Esters and Influenza Vaccination

Maastricht University Medical Center137 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

137

Conditions

Immune Response

Interventions

Influenza vaccineBIOLOGICAL

Single dose of the Influenza vaccine Participants have to wait until they are invited to receive the vaccine by the general practitioner; this study does not interfere with national planning of the vaccine

Plant stanol soft chews (2g per day)DIETARY_SUPPLEMENT

Participants have to consume 4 soft chews per day containing 0.5g plant stanols each (delivered as plant stanol esters), corresponding to a total plant stanol intake of 2g daily

Plant stanol soft chews (3g per day)DIETARY_SUPPLEMENT

Participants have to consume 6 soft chews per day containing 0.5g plant stanols each (delivered as plant stanol esters), corresponding to a total plant stanol intake of 3g daily

Eligibility

Sex: ALLMin age: 59 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Outcomes

Primary Outcomes

Vaccine specific IgM antibody titer

The response to the Influenza vaccine will be measured by quantifying the specific IgM antibody titer

Time frame: Maximal change from T=0 (change T=0 to T=3 weeks or T=4 weeks)

Secondary Outcomes

Vaccine specific IgG antibody titer

The response to the Influenza vaccine will be measured by quantifying the specific IgG antibody titer

Time frame: T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)

Immune parameters (1)

Cytokine production by PBMCs after stimulation with antiCD3-antiCD28 antiCD28 antibodies using the TruCulture system