Plant Stanol Esters and COVID-19 Vaccination Response
11 februari 2022 uppdaterad av: 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).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
48
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Limburg
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Maastricht, Limburg, Nederländerna, 6229ER
- Maastricht University Medical Center
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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-jämförare: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Vaccine specific antibody titers
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Immune parameters (1)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: T=-1 (start study)
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Height
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T=-1 (start study)
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Anthropometry (3)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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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Samarbetspartners och utredare
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Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
22 april 2021
Primärt slutförande (Faktisk)
11 januari 2022
Avslutad studie (Faktisk)
11 januari 2022
Studieregistreringsdatum
Först inskickad
13 april 2021
Först inskickad som uppfyllde QC-kriterierna
13 april 2021
Första postat (Faktisk)
14 april 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
2 mars 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 februari 2022
Senast verifierad
1 februari 2022
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- METC 21-013
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