NCT04844346

Plant Stanol Esters and COVID-19 Vaccination Response

The Effect of Plant Stanol Ester Consumption on the Vaccination Response to a COVID-19 Vaccine

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Plant stanols are known to lower low-density lipoprotein cholesterol (LDL-C). However, studies have suggested that these compounds also beneficially influence the immune system, e.g. increasing vaccine-specific antibody titers. BMI has previously been negatively associated to vaccination responses. If plant stanols indeed have beneficial effect on the immune system, people with overweight or obesity might benefit from consuming plant stanols prior to receiving the COVID-19 vaccination. The primary objective of this study is to demonstrate clinical benefits of consumption of plant stanols (delivered via products enriched with plant stanol esters) on the vaccination response to a COVID-19 vaccine in overweight or obese patients. The main study endpoint is vaccination response to a COVID-19 vaccine. Secondary endpoints include amongst others hematological, inflammatory and immunological parameters (e.g. hs-CRP, leukocyte differential count) and metabolic markers (e.g. blood lipid profiles, plasma glucose, serum insulin, HOMA-IR).

Conditions

• Overweight and Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Plant stanol mini drinks	Oat milk based mini drinks (100 mL) containing 2g plant stanols each (delivered as plant stanol esters).
DIETARY_SUPPLEMENT	Placebo mini drinks	Oat milk based mini drinks (100 mL) without added plant stanols (delivered as plant stanol esters).
BIOLOGICAL	COVID-19 vaccine	First dose of one of the COVID-19 vaccines. Participants have to wait until they are invited to receive the vaccine by the government; this study does not interfere with national planning of the vaccines.

Timeline

• Start date: 2021-04-22
• Primary completion: 2022-01-11
• Completion: 2022-01-11
• First posted: 2021-04-14
• Last updated: 2022-03-02

Locations

1 site across 1 country: Netherlands