Clinical trial

Evaluating the Effect of Different Daily Plant Stanol Ester Intakes on the Vaccination Response to an Influenza Vaccine

Name

METC 22-048

Description

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.

Trial arms

Trial start

2022-10-11

Estimated PCD

2022-12-20

Trial end

2022-12-20

Status

Completed

Treatment

Influenza vaccine

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

Arms:

Placebo group, Plant stanol group (2 grams per day), Plant stanol group (3 grams per day), Plant stanol group (4 grams per day)

Plant stanol soft chews (2g per day)

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

Arms:

Plant stanol group (2 grams per day)

Plant stanol soft chews (3g per day)

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

Arms:

Plant stanol group (3 grams per day)

Plant stanol soft chews (4g per day)

Participants have to consume 8 soft chews per day containing 0.5g plant stanols each (delivered as plant stanol esters), corresponding to a total plant stanol intake of 4g daily

Arms:

Plant stanol group (4 grams per day)

Control soft chews

Participants have to consume 6 control soft chews per day that does not contain plant stanols

Arms:

Placebo group

Size

137

Primary endpoint

Vaccine specific IgM antibody titer

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

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 137, 'type': 'ACTUAL'}}

Updated at

2023-01-31

1 organization

1 product

1 indication

Organization

Maastricht University Medical Center

Product

Influenza vaccine

Indication

immune response