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Completed

NCT Number: NCT05706350

Plant Stanol Esters and Influenza Vaccination

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.

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Key information

Conditions

Immune Response Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

59 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, Limburg, 6229ER, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

influenza vaccine

Biological

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 chews

Dietary Supplement

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Immune parameters (2)

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

    hsCRP

  4. 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

  5. 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

  6. 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

  7. 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

  8. Fasted metabolism (3)

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

    Plasma glucose

  9. Anthropometry (1)

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

    Body weight

  10. Anthropometry (2)

    Time frame: Day - 1 (start study)

    Height

  11. Anthropometry (3)

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

    Waist circumference

  12. Anthropometry (4)

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

    Hip circumference

  13. 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

  14. 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

  15. Liver elastography

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

    Fibroscan

  16. Liver fat content

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

    Fibroscan

  17. Diary outcomes (1)

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

    Adverse events as assessed by the diary

  18. Diary outcomes (2)

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

    Medication intake as assessed by the diary

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Raisio Nutrition Ltd.

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 31, 2023
Registry last updated
Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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