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Plant Stanol Esters and COVID-19 Vaccination Response

11 de febrero de 2022 actualizado por: 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).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

48

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Países Bajos
    • Limburg
      • Maastricht, Limburg, Países Bajos, 6229ER
        • Maastricht University Medical Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Plant stanol group
This arm receives 4g of plant stanols per day (delivered as plant stanol esters) by consuming mini drinks (100 mL each).
Suplemento dietético: Plant stanol mini drinks
Oat milk based mini drinks (100 mL) containing 2g plant stanols each (delivered as plant stanol esters).
Biológico: 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.
Comparador de placebos: Placebo group
This arm receives mini drinks without added plant stanols (delivered as plant stanol esters).
Biológico: 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.
Suplemento dietético: Placebo mini drinks
Oat milk based mini drinks (100 mL) without added plant stanols (delivered as plant stanol esters).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Vaccine specific antibody titers
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Immune parameters (1)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: T=-1 (start study)
Height
T=-1 (start study)
Anthropometry (3)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Maastricht University Medical Center

Colaboradores

Raisio Nutrition Ltd.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

22 de abril de 2021

Finalización primaria (Actual)

11 de enero de 2022

Finalización del estudio (Actual)

11 de enero de 2022

Fechas de registro del estudio

Enviado por primera vez

13 de abril de 2021

Primero enviado que cumplió con los criterios de control de calidad

13 de abril de 2021

Publicado por primera vez (Actual)

14 de abril de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de marzo de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

11 de febrero de 2022

Última verificación

1 de febrero de 2022

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • METC 21-013

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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