Plant Stanol Esters and COVID-19 Vaccination Response

Maastricht University Medical Centre (MUMC)

Status: Terminated

Conditions: Overweight and Obesity

Treatments: Biological: COVID-19 vaccine; Dietary Supplement: Plant stanol mini drinks; Dietary Supplement: Placebo mini drinks

Study type: Interventional

Funder types: Other

Identifiers

NCT04844346

METC 21-013

Details and patient eligibility

About

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).

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 2 patient groups, including a placebo group

Plant stanol group

Experimental group

Description:

This arm receives 4g of plant stanols per day (delivered as plant stanol esters) by consuming mini drinks (100 mL each).

Treatment:

Biological: COVID-19 vaccine

Dietary Supplement: Plant stanol mini drinks

Placebo group

Placebo Comparator group

Description:

This arm receives mini drinks without added plant stanols (delivered as plant stanol esters).

Treatment:

Biological: COVID-19 vaccine

Dietary Supplement: Placebo mini drinks