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Overweight and ObesityNCT04844346

Plant Stanol Esters and COVID-19 Vaccination Response

A study testing Plant stanol mini drinks and COVID-19 vaccine in people with Overweight and Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Overweight and Obesity
What is being tested?
Plant stanol mini drinks and COVID-19 vaccine
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteNetherlands
Study dates
22 Apr 2021to 11 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Netherlands1 site

  • Maastricht University Medical Center

    Maastricht, Limburg, 6229ER

Other trials in Netherlands

About this study

Official title: 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).

Being tested
Plant stanol mini drinks, Placebo mini drinks, COVID-19 vaccine
Keywords
Overweight, Obesity, COVID-19 vaccine, Immune system, Vaccination response
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Plant stanol mini drinksDietary supplement

    Oat milk based mini drinks (100 mL) containing 2g plant stanols each (delivered as plant stanol esters).

  • Placebo mini drinksDietary supplement

    Oat milk based mini drinks (100 mL) without added plant stanols (delivered as plant stanol esters).

  • COVID-19 vaccineBiological

    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.

Study groups in NCT04844346
Study groupRoleWhat they receive
Plant stanol groupExperimentalThis arm receives 4g of plant stanols per day (delivered as plant stanol esters) by consuming mini drinks (100 mL each).
Receives: Dietary Supplement: Plant stanol mini drinks; Biological: COVID-19 vaccine
Placebo groupPlacebo comparatorThis arm receives mini drinks without added plant stanols (delivered as plant stanol esters).
Receives: Dietary Supplement: Placebo mini drinks; Biological: COVID-19 vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change T=0 and T= 4 weeks

Secondary outcomes (16)

  1. Immune parameters (1)

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

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

  2. Immune parameters (2)

    hsCRP

    Measured: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)

  3. Leukocyte count

    Number of leukocytes measured in EDTA plasma

    Measured: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)

  4. Leukocyte differential count

    Number of subgroups of leukocytes measured in EDTA plasma

    Measured: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)

  5. Fasted metabolism (1)

    Serum non-cholesterol sterols and stanols

    Measured: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)

  6. Fasted metabolism (2)

    Serum lipid and lipoprotein profile

    Measured: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)

  7. Fasted metabolism (3)

    Glucose metabolism (including e.g. plasma glucose, serum insulin and calculated HOMA-IR)

    Measured: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)

  8. Anthropometry (1)

    Body weight

    Measured: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)

  9. Anthropometry (2)

    Height

    Measured: T=-1 (start study)

  10. Anthropometry (3)

    Waist circumference

    Measured: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)

  11. Anthropometry (4)

    Hip circumference

    Measured: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)

  12. Anthropometry (5)

    Waist-to-hip ratio

    Measured: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)

  13. Diet

    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

    Measured: T=-1 (start study) and T=4 weeks after vaccination (end study)

  14. Diary outcomes (1)

    General illness

    Measured: T=-1 (start study) until T=4 weeks after vaccination (end of study)

  15. Diary outcomes (2)

    Side effects COVID-19 vaccine

    Measured: T=0 (day before vaccination) until T=4 weeks after vaccination (end of study)

  16. Diary outcomes (3)

    Medication intake

    Measured: T=-1 (start study) until T=4 weeks after vaccination (end of study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2021
  2. Study start22 Apr 2021
  3. Primary completion11 Jan 2022
  4. Study completion11 Jan 2022

Why it stopped: Recruitment was dependent on finding participants that had to receive an initial COVID-19 vaccination and we were unable to find new participants anymore.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04844346
Sponsor's protocol ID
METC 21-013
Status last verified
Feb 2022
First submitted
13 Apr 2021
Last updated
2 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • van Brakel L, Mensink RP, Lutjohann D, Plat J. Plant stanol consumption increases anti-COVID-19 antibody responses, independent of changes in serum cholesterol concentrations: a randomized controlled trial. Am J Clin Nutr. 2024 Apr;119(4):969-980. doi: 10.1016/j.ajcnut.2024.01.017. Epub 2024 Jan 24.

    PubMed 38278364

Questions about this trial

What is this clinical trial studying?

A study testing Plant stanol mini drinks and COVID-19 vaccine in people with Overweight and Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Recruitment was dependent on finding participants that had to receive an initial COVID-19 vaccination and we were unable to find new participants anymore.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vaccine specific antibody titers (time frame: Change T=0 and T= 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04844346, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.

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