Plant Stanol Esters and COVID-19 Vaccination Response
- Conditions
- Overweight and Obesity
- Interventions
- Dietary Supplement: Placebo mini drinksDietary Supplement: Plant stanol mini drinksBiological: COVID-19 vaccine
- Registration Number
- NCT04844346
- Lead Sponsor
- Maastricht University Medical Center
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 48
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo group Placebo mini drinks This arm receives mini drinks without added plant stanols (delivered as plant stanol esters). Plant stanol group Plant stanol mini drinks This arm receives 4g of plant stanols per day (delivered as plant stanol esters) by consuming mini drinks (100 mL each). Plant stanol group COVID-19 vaccine This arm receives 4g of plant stanols per day (delivered as plant stanol esters) by consuming mini drinks (100 mL each). Placebo group COVID-19 vaccine This arm receives mini drinks without added plant stanols (delivered as plant stanol esters).
- Primary Outcome Measures
Name Time Method Vaccine specific antibody titers 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.
- Secondary Outcome Measures
Name Time Method Immune parameters (2) T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4) hsCRP
Fasted metabolism (2) T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4) Serum lipid and lipoprotein profile
Anthropometry (1) T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4) Body weight
Immune parameters (1) 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
Leukocyte count T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4) Number of leukocytes measured in EDTA plasma
Anthropometry (2) T=-1 (start study) Height
Diary outcomes (2) T=0 (day before vaccination) until T=4 weeks after vaccination (end of study) Side effects COVID-19 vaccine
Fasted metabolism (1) T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4) Serum non-cholesterol sterols and stanols
Anthropometry (3) T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4) Waist circumference
Diary outcomes (1) T=-1 (start study) until T=4 weeks after vaccination (end of study) General illness
Diary outcomes (3) T=-1 (start study) until T=4 weeks after vaccination (end of study) Medication intake
Fasted metabolism (3) 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)
Diet 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
Leukocyte differential count 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
Anthropometry (4) T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4) Hip circumference
Anthropometry (5) T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4) Waist-to-hip ratio
Trial Locations
- Locations (1)
Maastricht University Medical Center
🇳🇱Maastricht, Limburg, Netherlands