NCT05706350

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 11, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

2 months

First QC Date

January 11, 2023

Last Update Submit

January 20, 2023

Conditions

Immune Response

Keywords

Plant StanolsImmune systemInfluenza vaccination

Outcome Measures

Primary Outcomes (1)

  • Vaccine specific IgM antibody titer

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

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

Secondary Outcomes (18)

  • Vaccine specific IgG antibody titer

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

  • Immune parameters (1)

    Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)

  • Immune parameters (2)

    Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)

  • Leukocyte count

    Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)

  • Leukocyte differential count

    Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)

  • +13 more secondary outcomes

Study Arms (4)

Plant stanol group (2 grams per day)

EXPERIMENTAL

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

Biological: Influenza vaccineDietary Supplement: Plant stanol soft chews (2g per day)

Plant stanol group (3 grams per day)

EXPERIMENTAL

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

Biological: Influenza vaccineDietary Supplement: Plant stanol soft chews (3g per day)

Plant stanol group (4 grams per day)

EXPERIMENTAL

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

Biological: Influenza vaccineDietary Supplement: Plant stanol soft chews (4g per day)

Placebo group

PLACEBO COMPARATOR

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

Biological: Influenza vaccineDietary Supplement: Control soft chews

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

Placebo groupPlant 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)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 group (2 grams per day)
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

Plant stanol group (3 grams per day)
Plant stanol soft chews (4g per day)DIETARY_SUPPLEMENT

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

Plant stanol group (4 grams per day)
Control soft chewsDIETARY_SUPPLEMENT

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

Placebo group

Eligibility Criteria

Age59 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229ER, Netherlands

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2023

First Posted

January 31, 2023

Study Start

October 11, 2022

Primary Completion

December 20, 2022

Study Completion

December 20, 2022

Last Updated

January 31, 2023

Record last verified: 2023-01

Locations

NL(1)