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AzTrials

Immune ResponseNCT05706350

Plant Stanol Esters and Influenza Vaccination

A study testing Influenza vaccine, Plant stanol soft chews (2g per day) and Plant stanol soft chews (3g per day) in people with Immune Response, run by Maastricht University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 59 years and olderHealthy volunteers can take part
Conditions the study is for
Immune Response
What is being tested?
Influenza vaccine, Plant stanol soft chews (2g per day) and Plant stanol soft chews (3g per day)
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
137 participants
Where
1 siteNetherlands
Study dates
11 Oct 2022to 20 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 59 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Netherlands1 site

  • Maastricht University Medical Center

    Maastricht, Limburg, 6229ER

Other trials in Netherlands

About this study

Official title: 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.

Conditions
Immune Response
Being tested
Influenza vaccine, Plant stanol soft chews (2g per day), Plant stanol soft chews (3g per day), Plant stanol soft chews (4g per day), Control soft chews
Keywords
Plant Stanols, Immune system, Influenza vaccination
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • 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

  • Control soft chewsDietary supplement

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

Study groups in NCT05706350
Study groupRoleWhat they receive
Plant stanol group (2 grams per day)ExperimentalDietary 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
Receives: Biological: Influenza vaccine; Dietary Supplement: Plant stanol soft chews (2g per day)
Plant stanol group (3 grams per day)ExperimentalDietary 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
Receives: Biological: Influenza vaccine; Dietary Supplement: Plant stanol soft chews (3g per day)
Plant stanol group (4 grams per day)ExperimentalDietary 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
Receives: Biological: Influenza vaccine; Dietary Supplement: Plant stanol soft chews (4g per day)
Placebo groupPlacebo comparatorDietary Supplement: 6 placebo soft chews Soft chews that do not contain plant stanols
Receives: Biological: Influenza vaccine; Dietary Supplement: Control soft chews

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vaccine specific IgM antibody titer

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

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

Secondary outcomes (18)

  1. Vaccine specific IgG antibody titer

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

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

  2. Immune parameters (1)

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

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

  3. Immune parameters (2)

    hsCRP

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

  4. Leukocyte count

    Number of leukocytes measured in EDTA plasma

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

  5. Leukocyte differential count

    Number of subgroups of leukocytes measured in EDTA plasma

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

  6. Fasted metabolism (1)

    Serum non-cholesterol sterols and stanols

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

  7. Fasted metabolism (2)

    Serum lipid and lipoprotein profile

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

  8. Fasted metabolism (3)

    Plasma glucose

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

  9. Anthropometry (1)

    Body weight

    Measured: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)

  10. Anthropometry (2)

    Height

    Measured: Day - 1 (start study)

  11. Anthropometry (3)

    Waist circumference

    Measured: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)

  12. Anthropometry (4)

    Hip circumference

    Measured: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)

  13. Anthropometry (5)

    Waist-to-hip ratio

    Measured: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)

  14. Diet

    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

    Measured: Day - 1 (start study), T=4 weeks after vaccination (end of study)

  15. Liver elastography

    Fibroscan

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

  16. Liver fat content

    Fibroscan

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

  17. Diary outcomes (1)

    Adverse events as assessed by the diary

    Measured: Day - 1 (start study), T=4 weeks after vaccination (end of study)

  18. Diary outcomes (2)

    Medication intake as assessed by the diary

    Measured: Day - 1 (start study), T=4 weeks after vaccination (end of study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2023
  2. Study start11 Oct 2022
  3. Primary completion20 Dec 2022
  4. Study completion20 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
137 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05706350
Sponsor's protocol ID
METC 22-048
Status last verified
Jan 2023
First submitted
11 Jan 2023
Last updated
31 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Influenza vaccine, Plant stanol soft chews (2g per day) and Plant stanol soft chews (3g per day) in people with Immune Response, run by Maastricht University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vaccine specific IgM antibody titer (time frame: Maximal change from T=0 (change T=0 to T=3 weeks or T=4 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05706350.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023; AzTrials last refreshed its copy on 6 Nov 2026.

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