Clinical trial NCT04844346: Plant Stanol Esters and COVID-19 Vaccination Response
Official title: The Effect of Plant Stanol Ester Consumption on the Vaccination Response to a COVID-19 Vaccine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Overweight
Obesity
COVID-19 vaccine
Immune system
Vaccination response
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Raisio Nutrition Ltd.
First posted: 2021-04-14
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Vaccine specific antibody titers
timeFrame: Change T=0 and T= 4 weeks
Secondary outcomes:
measure: Immune parameters (1)
timeFrame: T=-1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination
measure: Immune parameters (2)
timeFrame: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
measure: Leukocyte count
timeFrame: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
measure: Leukocyte differential count
timeFrame: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
measure: Fasted metabolism (1)
timeFrame: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
measure: Fasted metabolism (2)
timeFrame: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
measure: Fasted metabolism (3)
timeFrame: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
measure: Anthropometry (1)
timeFrame: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
measure: Anthropometry (2)
timeFrame: T=-1 (start study)
measure: Anthropometry (3)
timeFrame: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
measure: Anthropometry (4)
timeFrame: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
measure: Anthropometry (5)
timeFrame: T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
measure: Diet
timeFrame: T=-1 (start study) and T=4 weeks after vaccination (end study)
measure: Diary outcomes (1)
timeFrame: T=-1 (start study) until T=4 weeks after vaccination (end of study)
measure: Diary outcomes (2)
timeFrame: T=0 (day before vaccination) until T=4 weeks after vaccination (end of study)
measure: Diary outcomes (3)
timeFrame: T=-1 (start study) until T=4 weeks after vaccination (end of study)
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Jogchum Plat, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Center
name: Ronald P Mensink, PhD
role: PRINCIPAL_INVESTIGATOR
References: