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

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001080-24-NL

Enrollment

100

Registered

2021-03-18

Start date

2021-04-08

Completion date

Unknown

Last updated

2022-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 vaccination respons of people with BMI 27-35 kg/m2

Interventions

Trade Name: The effect of plant stanols on the COVID-19 vaccination repsonse will be studied. Several vaccines will be used (e.g. AstraZeneca). Pharmaceutical Form: Suspension for injection

Eligibility

Sex/Gender

All

Inclusion criteria

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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: Already received COVID-19 vaccination, already had a positive test for COVID-19 (all tests, e.g. PCR test or antibody test), allergy to an ingredient of the mini drinks, excessive alcohol use (>20 consumptions per week), regular use of drugs, blood donors that want to donate one month prior to or during the study, pregnant or breastfeeding women

Design outcomes

Primary

Measure	Time frame
Main Objective: 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 aged 18 years or older. ;Secondary Objective: 1. To evaluate the effect of plant stanol esters on metabolic parameters (e.g. glucose, insulin, blood lipid and lipoprotein profile). 2. To evaluate the effect of plant stanol esters on hematological and immunological parameters (e.g. leukocyte differential count, hsCRP, cytokine production by stimulated PBMCs) ;Primary end point(s): COVID-19 vaccination specific antibody response (IgG, IgM);Timepoint(s) of evaluation of this end point: Two times prior to the vaccination, four times following the month after vaccination	—

Measure

Time frame

Main Objective: 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 aged 18 years or older. ;Secondary Objective: 1. To evaluate the effect of plant stanol esters on metabolic parameters (e.g. glucose, insulin, blood lipid and lipoprotein profile). 2. To evaluate the effect of plant stanol esters on hematological and immunological parameters (e.g. leukocyte differential count, hsCRP, cytokine production by stimulated PBMCs) ;Primary end point(s): COVID-19 vaccination specific antibody response (IgG, IgM);Timepoint(s) of evaluation of this end point: Two times prior to the vaccination, four times following the month after vaccination

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Secondary

Measure	Time frame
Secondary end point(s): • Cytokine concentrations by stimulated PBMCs • Plasma markers for inflammation (hsCRP) • Hematology (leukocyte count, leukocyte differential count) • Serum plant stanol concentrations (sitostanol, campestanol) for compliance • Serum lipid and lipoprotein profile (TC, HDL-C, LDL-C, TAG) • Serum non-cholesterol sterols which are markers for intestinal cholesterol absorption (sitosterol, campesterol, cholestanol) or endogenous synthesis (lathosterol, desmosterol) • Plasma glucose, serum insulin concentrations and (calculated) HOMA-IR • Anthropometry (body weight, waist circumference, waist to hip ratio, height, BMI) ;Timepoint(s) of evaluation of this end point: Two times prior to the vaccination, four times in the month following vaccination	—

Measure

Time frame

Secondary end point(s): • Cytokine concentrations by stimulated PBMCs • Plasma markers for inflammation (hsCRP) • Hematology (leukocyte count, leukocyte differential count) • Serum plant stanol concentrations (sitostanol, campestanol) for compliance • Serum lipid and lipoprotein profile (TC, HDL-C, LDL-C, TAG) • Serum non-cholesterol sterols which are markers for intestinal cholesterol absorption (sitosterol, campesterol, cholestanol) or endogenous synthesis (lathosterol, desmosterol) • Plasma glucose, serum insulin concentrations and (calculated) HOMA-IR • Anthropometry (body weight, waist circumference, waist to hip ratio, height, BMI) ;Timepoint(s) of evaluation of this end point: Two times prior to the vaccination, four times in the month following vaccination

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Countries

Netherlands

Contacts

Public ContactPrincipal Investigator

Maastricht University

j.plat@maastrichtuniversity.nl+31433881309

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026