Plant Stanol Esters and COVID-19 Vaccination Response

February 11, 2022 updated by: Maastricht University Medical Center

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229ER
        • Maastricht University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Plant stanol group
This arm receives 4g of plant stanols per day (delivered as plant stanol esters) by consuming mini drinks (100 mL each).
Dietary supplement: Plant stanol mini drinks
Oat milk based mini drinks (100 mL) containing 2g plant stanols each (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.
Placebo Comparator: Placebo group
This arm receives mini drinks 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.
Dietary supplement: Placebo mini drinks
Oat milk based mini drinks (100 mL) without added plant stanols (delivered as plant stanol esters).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Vaccine specific antibody titers
Time Frame: Change T=0 and T= 4 weeks
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.
Change T=0 and T= 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Immune parameters (1)
Time Frame: T=-1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination
Cytokine production by PBMCs after stimulation with antiCD3-antiCD28 antiCD28 antibodies using the TruCulture system
T=-1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination
Immune parameters (2)
Time Frame: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
hsCRP
T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Leukocyte count
Time Frame: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Number of leukocytes measured in EDTA plasma
T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Leukocyte differential count
Time Frame: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Number of subgroups of leukocytes measured in EDTA plasma
T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Fasted metabolism (1)
Time Frame: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Serum non-cholesterol sterols and stanols
T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Fasted metabolism (2)
Time Frame: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Serum lipid and lipoprotein profile
T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Fasted metabolism (3)
Time Frame: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Glucose metabolism (including e.g. plasma glucose, serum insulin and calculated HOMA-IR)
T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Anthropometry (1)
Time Frame: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Body weight
T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Anthropometry (2)
Time Frame: T=-1 (start study)
Height
T=-1 (start study)
Anthropometry (3)
Time Frame: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Waist circumference
T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Anthropometry (4)
Time Frame: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Hip circumference
T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Anthropometry (5)
Time Frame: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Waist-to-hip ratio
T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Diet
Time Frame: T=-1 (start study) and T=4 weeks after vaccination (end study)
Food frequency questionnaire is used to determine if the participants maintain their habitual diet and to determine if the participants do not consume plant stanols and/or sterols outside the intervention
T=-1 (start study) and T=4 weeks after vaccination (end study)
Diary outcomes (1)
Time Frame: T=-1 (start study) until T=4 weeks after vaccination (end of study)
General illness
T=-1 (start study) until T=4 weeks after vaccination (end of study)
Diary outcomes (2)
Time Frame: T=0 (day before vaccination) until T=4 weeks after vaccination (end of study)
Side effects COVID-19 vaccine
T=0 (day before vaccination) until T=4 weeks after vaccination (end of study)
Diary outcomes (3)
Time Frame: T=-1 (start study) until T=4 weeks after vaccination (end of study)
Medication intake
T=-1 (start study) until T=4 weeks after vaccination (end of study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maastricht University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Raisio Nutrition Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 22, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 11, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 11, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • METC 21-013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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