Plant Stanol Esters and COVID-19 Vaccination Response

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

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).

Inclusion Criteria:

• Men and women
• Aged 18 years or older
• BMI between 27 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 COVID-19 vaccination
• Already had a positive test for COVID-19 (this includes all types of tests, e.g. PCR tests or antibody tests)
• Allergy to an ingredient of the mini drinks
• Having donated blood within one month prior to the start of the study, or planning to donate blood during the study
• Pregnant women
• Breastfeeding women
• Excessive alcohol use (>20 consumptions per week)
• Regular use of soft or hard drugs