NCT05706350

Plant Stanol Esters and Influenza Vaccination

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 59 Years
• Healthy volunteers: Accepted

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.

Conditions

• Immune Response

Interventions

Type	Name	Description
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
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
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
DIETARY_SUPPLEMENT	Control soft chews	Participants have to consume 6 control soft chews per day that does not contain plant stanols

Timeline

• Start date: 2022-10-11
• Primary completion: 2022-12-20
• Completion: 2022-12-20
• First posted: 2023-01-31
• Last updated: 2023-01-31

Locations

1 site across 1 country: Netherlands