Immune Response
Conditions
Keywords
Plant Stanols, Immune system, Influenza vaccination
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.
Interventions
BIOLOGICALInfluenza 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_SUPPLEMENTPlant 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
DIETARY_SUPPLEMENTPlant 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
DIETARY_SUPPLEMENTPlant 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
DIETARY_SUPPLEMENTControl soft chews
Participants have to consume 6 control soft chews per day that does not contain plant stanols
Sponsors
Raisio Nutrition Ltd.
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
59 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaccine specific IgM antibody titer | 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
| Measure | Time frame | Description |
|---|---|---|
| Immune parameters (1) | 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 |
| Immune parameters (2) | Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study) | hsCRP |
| Leukocyte count | Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study) | Number of leukocytes measured in EDTA plasma |
| Leukocyte differential count | 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 |
| Fasted metabolism (1) | Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study) | Serum non-cholesterol sterols and stanols |
| Fasted metabolism (2) | Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study) | Serum lipid and lipoprotein profile |
| Fasted metabolism (3) | Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study) | Plasma glucose |
| Anthropometry (1) | Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4) | Body weight |
| Vaccine specific IgG antibody titer | 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 |
| Anthropometry (3) | Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4) | Waist circumference |
| Anthropometry (4) | Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4) | Hip circumference |
| Anthropometry (5) | Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4) | Waist-to-hip ratio |
| Diet | 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 |
| Liver elastography | Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study) | Fibroscan |
| Liver fat content | Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study) | Fibroscan |
| Diary outcomes (1) | Day - 1 (start study), T=4 weeks after vaccination (end of study) | Adverse events as assessed by the diary |
| Diary outcomes (2) | Day - 1 (start study), T=4 weeks after vaccination (end of study) | Medication intake as assessed by the diary |
| Anthropometry (2) | Day - 1 (start study) | Height |
Countries
Netherlands
Outcome results
None listed