Plant Stanol Esters and COVID-19 Vaccination Response
11 février 2022 mis à jour par: 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).
Aperçu de l'étude
Statut
Résilié
Les conditions
Type d'étude
Interventionnel
Inscription (Réel)
48
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Limburg
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Maastricht, Limburg, Pays-Bas, 6229ER
- Maastricht University Medical Center
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Plant stanol group
This arm receives 4g of plant stanols per day (delivered as plant stanol esters) by consuming mini drinks (100 mL each).
|
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.
|
|
Comparateur placebo: Placebo group
This arm receives mini drinks without added plant stanols (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.
Oat milk based mini drinks (100 mL) without added plant stanols (delivered as plant stanol esters).
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Vaccine specific antibody titers
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Immune parameters (1)
Délai: 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)
Délai: 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
Délai: 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)
|
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Leukocyte differential count
Délai: 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)
Délai: 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
|
T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
|
|
Fasted metabolism (2)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: T=-1 (start study)
|
Height
|
T=-1 (start study)
|
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Anthropometry (3)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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)
Délai: T=-1 (start study) until T=4 weeks after vaccination (end of study)
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General illness
|
T=-1 (start study) until T=4 weeks after vaccination (end of study)
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Diary outcomes (2)
Délai: 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)
Délai: 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)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
22 avril 2021
Achèvement primaire (Réel)
11 janvier 2022
Achèvement de l'étude (Réel)
11 janvier 2022
Dates d'inscription aux études
Première soumission
13 avril 2021
Première soumission répondant aux critères de contrôle qualité
13 avril 2021
Première publication (Réel)
14 avril 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
2 mars 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 février 2022
Dernière vérification
1 février 2022
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- METC 21-013
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .