Plant Stanol Esters and COVID-19 Vaccination Response
11 februari 2022 bijgewerkt door: 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).
Studie Overzicht
Toestand
Beëindigd
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
48
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Limburg
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Maastricht, Limburg, Nederland, 6229ER
- Maastricht University Medical Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Plant stanol group
This arm receives 4g of plant stanols per day (delivered as plant stanol esters) by consuming mini drinks (100 mL each).
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Oat milk based mini drinks (100 mL) containing 2g plant stanols each (delivered as plant stanol esters).
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.
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Placebo-vergelijker: Placebo group
This arm receives mini drinks without added plant stanols (delivered as plant stanol esters).
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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.
Oat milk based mini drinks (100 mL) without added plant stanols (delivered as plant stanol esters).
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Vaccine specific antibody titers
Tijdsspanne: Change T=0 and T= 4 weeks
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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.
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Change T=0 and T= 4 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Immune parameters (1)
Tijdsspanne: T=-1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination
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Cytokine production by PBMCs after stimulation with antiCD3-antiCD28 antiCD28 antibodies using the TruCulture system
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T=-1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination
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Immune parameters (2)
Tijdsspanne: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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hsCRP
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T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Leukocyte count
Tijdsspanne: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Number of leukocytes measured in EDTA plasma
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T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Leukocyte differential count
Tijdsspanne: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Number of subgroups of leukocytes measured in EDTA plasma
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T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Fasted metabolism (1)
Tijdsspanne: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Serum non-cholesterol sterols and stanols
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T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Fasted metabolism (2)
Tijdsspanne: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Serum lipid and lipoprotein profile
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T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Fasted metabolism (3)
Tijdsspanne: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Glucose metabolism (including e.g.
plasma glucose, serum insulin and calculated HOMA-IR)
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T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Anthropometry (1)
Tijdsspanne: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Body weight
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T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Anthropometry (2)
Tijdsspanne: T=-1 (start study)
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Height
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T=-1 (start study)
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Anthropometry (3)
Tijdsspanne: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Waist circumference
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T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Anthropometry (4)
Tijdsspanne: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Hip circumference
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T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Anthropometry (5)
Tijdsspanne: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Waist-to-hip ratio
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T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Diet
Tijdsspanne: T=-1 (start study) and T=4 weeks after vaccination (end study)
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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
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T=-1 (start study) and T=4 weeks after vaccination (end study)
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Diary outcomes (1)
Tijdsspanne: T=-1 (start study) until T=4 weeks after vaccination (end of study)
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General illness
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T=-1 (start study) until T=4 weeks after vaccination (end of study)
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Diary outcomes (2)
Tijdsspanne: T=0 (day before vaccination) until T=4 weeks after vaccination (end of study)
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Side effects COVID-19 vaccine
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T=0 (day before vaccination) until T=4 weeks after vaccination (end of study)
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Diary outcomes (3)
Tijdsspanne: T=-1 (start study) until T=4 weeks after vaccination (end of study)
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Medication intake
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T=-1 (start study) until T=4 weeks after vaccination (end of study)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
22 april 2021
Primaire voltooiing (Werkelijk)
11 januari 2022
Studie voltooiing (Werkelijk)
11 januari 2022
Studieregistratiedata
Eerst ingediend
13 april 2021
Eerst ingediend dat voldeed aan de QC-criteria
13 april 2021
Eerst geplaatst (Werkelijk)
14 april 2021
Updates van studierecords
Laatste update geplaatst (Werkelijk)
2 maart 2022
Laatste update ingediend die voldeed aan QC-criteria
11 februari 2022
Laatst geverifieerd
1 februari 2022
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- METC 21-013
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .