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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05706350
Other study ID # METC 22-048
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 11, 2022
Est. completion date December 20, 2022

Study information

Verified date January 2023
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 137
Est. completion date December 20, 2022
Est. primary completion date December 20, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 59 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Influenza 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 Supplement:
Plant 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
Plant 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
Plant 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
Control soft chews
Participants have to consume 6 control soft chews per day that does not contain plant stanols

Locations

Country Name City State
Netherlands Maastricht University Medical Center Maastricht Limburg

Sponsors (2)

Lead Sponsor Collaborator
Maastricht University Medical Center Raisio Nutrition Ltd.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Vaccine specific IgM antibody titer The response to the Influenza vaccine will be measured by quantifying the specific IgM antibody titer Maximal change from T=0 (change T=0 to T=3 weeks or T=4 weeks)
Secondary Vaccine specific IgG antibody titer The response to the Influenza vaccine will be measured by quantifying the specific IgG antibody titer T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Secondary Immune parameters (1) Cytokine production by PBMCs after stimulation with antiCD3-antiCD28 antiCD28 antibodies using the TruCulture system Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Secondary Immune parameters (2) hsCRP Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Secondary Leukocyte count Number of leukocytes measured in EDTA plasma Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Secondary Leukocyte differential count Number of subgroups of leukocytes measured in EDTA plasma Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Secondary Fasted metabolism (1) Serum non-cholesterol sterols and stanols Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Secondary Fasted metabolism (2) Serum lipid and lipoprotein profile Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Secondary Fasted metabolism (3) Plasma glucose Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Secondary Anthropometry (1) Body weight Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Secondary Anthropometry (2) Height Day - 1 (start study)
Secondary Anthropometry (3) Waist circumference Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Secondary Anthropometry (4) Hip circumference Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Secondary Anthropometry (5) Waist-to-hip ratio Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Secondary 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 Day - 1 (start study), T=4 weeks after vaccination (end of study)
Secondary Liver elastography Fibroscan Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Secondary Liver fat content Fibroscan Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Secondary Diary outcomes (1) Adverse events as assessed by the diary Day - 1 (start study), T=4 weeks after vaccination (end of study)
Secondary Diary outcomes (2) Medication intake as assessed by the diary Day - 1 (start study), T=4 weeks after vaccination (end of study)
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