Plant Stanol Esters and Influenza Vaccination

• Sponsor: Maastricht University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT05706350
• Collaborator: Raisio Nutrition Ltd. (Other)
• Enrollment: 137
• Location: 1
• Arms: 4
• Actual Duration (Months): 2.3
• Patients Per Site Per Month: 59.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Immune Response	Biological: Influenza vaccine; Dietary Supplement: Plant stanol soft chews (2g per day); Dietary Supplement: Plant stanol soft chews (3g per day); Dietary Supplement: Plant stanol soft chews (4g per day); Dietary Supplement: Control soft chews	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 137 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Evaluating the Effect of Different Daily Plant Stanol Ester Intakes on the Vaccination Response to an Influenza Vaccine
• Actual Study Start Date: Oct 11, 2022
• Actual Primary Completion Date: Dec 20, 2022
• Actual Study Completion Date: Dec 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Plant stanol group (2 grams 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	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
Experimental: Plant stanol group (3 grams 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	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 (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
Experimental: Plant stanol group (4 grams 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	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 (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
Placebo Comparator: Placebo group Dietary Supplement: 6 placebo soft chews Soft chews that do not contain plant stanols	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: Control soft chews; Participants have to consume 6 control soft chews per day that does not contain plant stanols

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. Immune parameters (2) [Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)]

   hsCRP

4. 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

5. 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

6. 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

7. 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

8. Fasted metabolism (3) [Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)]

   Plasma glucose

9. Anthropometry (1) [Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)]

   Body weight

10. Anthropometry (2) [Day - 1 (start study)]

    Height

11. Anthropometry (3) [Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)]

    Waist circumference

12. Anthropometry (4) [Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)]

    Hip circumference

13. Anthropometry (5) [Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)]

    Waist-to-hip ratio

14. 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

15. Liver elastography [Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)]

    Fibroscan

16. Liver fat content [Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)]

    Fibroscan

17. Diary outcomes (1) [Day - 1 (start study), T=4 weeks after vaccination (end of study)]

    Adverse events as assessed by the diary

18. Diary outcomes (2) [Day - 1 (start study), T=4 weeks after vaccination (end of study)]

    Medication intake as assessed by the diary

Eligibility Criteria

Criteria

• Ages Eligible for Study: 59 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maastricht University Medical Center	Maastricht	Limburg	Netherlands	6229ER

Sponsors and Collaborators

• Maastricht University Medical Center
• Raisio Nutrition Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maastricht University Medical Center
• ClinicalTrials.gov Identifier: NCT05706350
• Other Study ID Numbers: METC 22-048
• First Posted: Jan 31, 2023
• Last Update Posted: Jan 31, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Maastricht University Medical Center: Plant Stanols; Immune system; Influenza vaccination
• Additional relevant MeSH terms: Influenza, Human

Study Results

No Results Posted as of Jan 31, 2023