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Plant Stanol Esters and COVID-19 Vaccination Response

11. februar 2022 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

48

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Plant stanol group
This arm receives 4g of plant stanols per day (delivered as plant stanol esters) by consuming mini drinks (100 mL each).
Kosttilskud: Plant stanol mini drinks
Oat milk based mini drinks (100 mL) containing 2g plant stanols each (delivered as plant stanol esters).
Biologisk: 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 komparator: Placebo group
This arm receives mini drinks without added plant stanols (delivered as plant stanol esters).
Biologisk: 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.
Kosttilskud: Placebo mini drinks
Oat milk based mini drinks (100 mL) without added plant stanols (delivered as plant stanol esters).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Vaccine specific antibody titers
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Immune parameters (1)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: T=-1 (start study)
Height
T=-1 (start study)
Anthropometry (3)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Maastricht University Medical Center

Samarbejdspartnere

Raisio Nutrition Ltd.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

22. april 2021

Primær færdiggørelse (Faktiske)

11. januar 2022

Studieafslutning (Faktiske)

11. januar 2022

Datoer for studieregistrering

Først indsendt

13. april 2021

Først indsendt, der opfyldte QC-kriterier

13. april 2021

Først opslået (Faktiske)

14. april 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. marts 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. februar 2022

Sidst verificeret

1. februar 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • METC 21-013

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