Plant Stanol Esters and Influenza Vaccination

January 20, 2023 updated by: Maastricht University Medical Center

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
137

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229ER
        • Maastricht University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

59 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Plant stanol group (2 grams per day)
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 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
Dietary supplement: 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
Experimental: Plant stanol group (3 grams per day)
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 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
Dietary supplement: 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
Experimental: Plant stanol group (4 grams per day)
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 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
Dietary supplement: 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
Placebo Comparator: Placebo group
Dietary Supplement: 6 placebo soft chews Soft chews that do not contain plant stanols
Biological: 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
Dietary supplement: Control soft chews
Participants have to consume 6 control soft chews per day that does not contain plant stanols

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Vaccine specific IgM antibody titer
Time Frame: Maximal change from T=0 (change T=0 to T=3 weeks or T=4 weeks)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Vaccine specific IgG antibody titer
Time Frame: T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
The response to the Influenza vaccine will be measured by quantifying the specific IgG antibody titer
T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Immune parameters (1)
Time Frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Cytokine production by PBMCs after stimulation with antiCD3-antiCD28 antiCD28 antibodies using the TruCulture system
Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Immune parameters (2)
Time Frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
hsCRP
Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Leukocyte count
Time Frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Number of leukocytes measured in EDTA plasma
Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Leukocyte differential count
Time Frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Number of subgroups of leukocytes measured in EDTA plasma
Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Fasted metabolism (1)
Time Frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Serum non-cholesterol sterols and stanols
Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Fasted metabolism (2)
Time Frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Serum lipid and lipoprotein profile
Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Fasted metabolism (3)
Time Frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Plasma glucose
Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Anthropometry (1)
Time Frame: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Body weight
Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Anthropometry (2)
Time Frame: Day - 1 (start study)
Height
Day - 1 (start study)
Anthropometry (3)
Time Frame: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Waist circumference
Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Anthropometry (4)
Time Frame: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Hip circumference
Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Anthropometry (5)
Time Frame: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Waist-to-hip ratio
Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Diet
Time Frame: Day - 1 (start study), T=4 weeks after vaccination (end of study)
Food frequency questionnaire is used to determine if the participants maintain their habitual diet and to determine if the participants do not consume plant stanols and/or sterols outside the intervention
Day - 1 (start study), T=4 weeks after vaccination (end of study)
Liver elastography
Time Frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Fibroscan
Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Liver fat content
Time Frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Fibroscan
Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Diary outcomes (1)
Time Frame: Day - 1 (start study), T=4 weeks after vaccination (end of study)
Adverse events as assessed by the diary
Day - 1 (start study), T=4 weeks after vaccination (end of study)
Diary outcomes (2)
Time Frame: Day - 1 (start study), T=4 weeks after vaccination (end of study)
Medication intake as assessed by the diary
Day - 1 (start study), T=4 weeks after vaccination (end of study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maastricht University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Raisio Nutrition Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 11, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 31, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • METC 22-048

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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