Plant Stanol Esters and COVID-19 Vaccination Response

Maastricht University Medical Center48 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Overweight and Obesity

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Vaccine specific antibody titers

The response to the COVID-19 vaccine will be measured by quantifying specific antibody titers (vaccine specific IgG and IgM). These titers will be measured in blood samples collected weekly during the month after vaccination by suitable ELISAs.

Time frame: Change T=0 and T= 4 weeks

Secondary Outcomes

Immune parameters (1)

Cytokine production by PBMCs after stimulation with antiCD3-antiCD28 antiCD28 antibodies using the TruCulture system

Time frame: T=-1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination

Immune parameters (2)

hsCRP