Back to resultsPlant Stanol Esters and Influenza Vaccination
Primary Purpose
Immune Response
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
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
Sponsored by
About this trial
This is an interventional prevention trial for Immune Response focused on measuring Plant Stanols, Immune system, Influenza vaccination
Eligibility Criteria
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
Sites / Locations
- Maastricht University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Plant stanol group (2 grams per day)
Plant stanol group (3 grams per day)
Plant stanol group (4 grams per day)
Placebo group
Arm Description
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
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
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
Dietary Supplement: 6 placebo soft chews Soft chews that do not contain plant stanols
Outcomes
Primary Outcome Measures
Vaccine specific IgM antibody titer
The response to the Influenza vaccine will be measured by quantifying the specific IgM antibody titer
Secondary Outcome Measures
Vaccine specific IgG antibody titer
The response to the Influenza vaccine will be measured by quantifying the specific IgG antibody titer
Immune parameters (1)
Cytokine production by PBMCs after stimulation with antiCD3-antiCD28 antiCD28 antibodies using the TruCulture system
Immune parameters (2)
hsCRP
Leukocyte count
Number of leukocytes measured in EDTA plasma
Leukocyte differential count
Number of subgroups of leukocytes measured in EDTA plasma
Fasted metabolism (1)
Serum non-cholesterol sterols and stanols
Fasted metabolism (2)
Serum lipid and lipoprotein profile
Fasted metabolism (3)
Plasma glucose
Anthropometry (1)
Body weight
Anthropometry (2)
Height
Anthropometry (3)
Waist circumference
Anthropometry (4)
Hip circumference
Anthropometry (5)
Waist-to-hip ratio
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
Liver elastography
Fibroscan
Liver fat content
Fibroscan
Diary outcomes (1)
Adverse events as assessed by the diary
Diary outcomes (2)
Medication intake as assessed by the diary
Full Information
NCT ID
NCT05706350
First Posted
January 11, 2023
Last Updated
January 20, 2023
Sponsor
Maastricht University Medical Center
Collaborators
Raisio Nutrition Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05706350
Brief Title
Plant Stanol Esters and Influenza Vaccination
Official Title
Evaluating the Effect of Different Daily Plant Stanol Ester Intakes on the Vaccination Response to an Influenza Vaccine
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 11, 2022 (Actual)
Primary Completion Date
December 20, 2022 (Actual)
Study Completion Date
December 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Raisio Nutrition Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Response
Keywords
Plant Stanols, Immune system, Influenza vaccination
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
137 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Plant stanol group (2 grams per day)
Arm Type
Experimental
Arm Description
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
Arm Title
Plant stanol group (3 grams per day)
Arm Type
Experimental
Arm Description
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
Arm Title
Plant stanol group (4 grams per day)
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Dietary Supplement: 6 placebo soft chews Soft chews that do not contain plant stanols
Intervention Type
Biological
Intervention Name(s)
Influenza vaccine
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Plant stanol soft chews (2g per day)
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Plant stanol soft chews (3g per day)
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Plant stanol soft chews (4g per day)
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Control soft chews
Intervention Description
Participants have to consume 6 control soft chews per day that does not contain plant stanols
Primary Outcome Measure Information:
Title
Vaccine specific IgM antibody titer
Description
The response to the Influenza vaccine will be measured by quantifying the specific IgM antibody titer
Time Frame
Maximal change from T=0 (change T=0 to T=3 weeks or T=4 weeks)
Secondary Outcome Measure Information:
Title
Vaccine specific IgG antibody titer
Description
The response to the Influenza vaccine will be measured by quantifying the specific IgG antibody titer
Time Frame
T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Title
Immune parameters (1)
Description
Cytokine production by PBMCs after stimulation with antiCD3-antiCD28 antiCD28 antibodies using the TruCulture system
Time Frame
Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Title
Immune parameters (2)
Description
hsCRP
Time Frame
Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Title
Leukocyte count
Description
Number of leukocytes measured in EDTA plasma
Time Frame
Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Title
Leukocyte differential count
Description
Number of subgroups of leukocytes measured in EDTA plasma
Time Frame
Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Title
Fasted metabolism (1)
Description
Serum non-cholesterol sterols and stanols
Time Frame
Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Title
Fasted metabolism (2)
Description
Serum lipid and lipoprotein profile
Time Frame
Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Title
Fasted metabolism (3)
Description
Plasma glucose
Time Frame
Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Title
Anthropometry (1)
Description
Body weight
Time Frame
Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Title
Anthropometry (2)
Description
Height
Time Frame
Day - 1 (start study)
Title
Anthropometry (3)
Description
Waist circumference
Time Frame
Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Title
Anthropometry (4)
Description
Hip circumference
Time Frame
Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Title
Anthropometry (5)
Description
Waist-to-hip ratio
Time Frame
Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Title
Diet
Description
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
Time Frame
Day - 1 (start study), T=4 weeks after vaccination (end of study)
Title
Liver elastography
Description
Fibroscan
Time Frame
Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Title
Liver fat content
Description
Fibroscan
Time Frame
Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Title
Diary outcomes (1)
Description
Adverse events as assessed by the diary
Time Frame
Day - 1 (start study), T=4 weeks after vaccination (end of study)
Title
Diary outcomes (2)
Description
Medication intake as assessed by the diary
Time Frame
Day - 1 (start study), T=4 weeks after vaccination (end of study)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229ER
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Plant Stanol Esters and Influenza Vaccination
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