Plant Stanol Esters and Influenza Vaccination

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Immune Response

Treatments: Dietary Supplement: Plant stanol soft chews (3g per day); Dietary Supplement: Plant stanol soft chews (4g per day); Dietary Supplement: Plant stanol soft chews (2g per day); Dietary Supplement: Control soft chews; Biological: Influenza vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT05706350

METC 22-048

Details and patient eligibility

About

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.

Enrollment: 137 patients

Sex: All

Ages: 59+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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137 participants in 4 patient groups, including a placebo group

Plant stanol group (2 grams per day)

Experimental group

Description:

Dietary Supplement: 4 soft chews containing 0.5g plant stanols each (delivered as plant stanol esters) Soft chews containing 0.5g plant stanols each delivered as plant stanol esters

Treatment:

Dietary Supplement: Plant stanol soft chews (2g per day)

Biological: Influenza vaccine

Plant stanol group (3 grams per day)

Experimental group

Description:

Dietary Supplement: 6 soft chews containing 0.5g plant stanols each (delivered as plant stanol esters) Soft chews containing 0.5g plant stanols each delivered as plant stanol esters

Treatment:

Biological: Influenza vaccine

Dietary Supplement: Plant stanol soft chews (3g per day)

Plant stanol group (4 grams per day)

Experimental group

Description:

Dietary Supplement: 8 soft chews containing 0.5g plant stanols each (delivered as plant stanol esters) Soft chews containing 0.5g plant stanols each delivered as plant stanol esters

Treatment:

Dietary Supplement: Plant stanol soft chews (4g per day)

Biological: Influenza vaccine

Placebo group

Placebo Comparator group

Description:

Dietary Supplement: 6 placebo soft chews Soft chews that do not contain plant stanols

Treatment:

Dietary Supplement: Control soft chews

Biological: Influenza vaccine