Plant Stanol Esters and Influenza Vaccination
- Conditions
- Immune Response
- Interventions
- Biological: Influenza vaccineDietary Supplement: Plant stanol soft chews (2g per day)Dietary Supplement: Plant stanol soft chews (3g per day)Dietary Supplement: Control soft chewsDietary Supplement: Plant stanol soft chews (4g per day)
- Registration Number
- NCT05706350
- Lead Sponsor
- Maastricht University Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 137
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Plant stanol group (2 grams per day) Influenza vaccine 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 Placebo group Influenza vaccine Dietary Supplement: 6 placebo soft chews Soft chews that do not contain plant stanols Plant stanol group (2 grams per day) Plant stanol soft chews (2g 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 Plant stanol group (3 grams per day) Plant stanol soft chews (3g 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 Plant stanol group (4 grams per day) Influenza vaccine 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 Placebo group Control soft chews Dietary Supplement: 6 placebo soft chews Soft chews that do not contain plant stanols Plant stanol group (3 grams per day) Influenza vaccine 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 Plant stanol group (4 grams per day) Plant stanol soft chews (4g 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
Anthropometry (1) Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4) Body weight
Anthropometry (5) Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4) Waist-to-hip ratio
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
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 (4) Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4) Hip circumference
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
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
Immune parameters (2) Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study) hsCRP
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
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
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
Trial Locations
- Locations (1)
Maastricht University Medical Center
🇳🇱Maastricht, Limburg, Netherlands