Plant Stanol Esters and Influenza Vaccination

Immune Response Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05706350
• Other study ID #: METC 22-048
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Immune Response
• Influenza, Human

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)