Overweight and Obesity
Conditions
Keywords
Overweight, Obesity, COVID-19 vaccine, Immune system, Vaccination response
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).
Interventions
DIETARY_SUPPLEMENTPlant stanol mini drinks
Oat milk based mini drinks (100 mL) containing 2g plant stanols each (delivered as plant stanol esters).
DIETARY_SUPPLEMENTPlacebo mini drinks
Oat milk based mini drinks (100 mL) without added plant stanols (delivered as plant stanol esters).
BIOLOGICALCOVID-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.
Sponsors
Raisio Nutrition Ltd.
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Immune parameters (2) | T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4) | hsCRP |
| 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 |
| 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 |
| 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 |
| 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 |
| 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) |
| 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 |
| Anthropometry (3) | T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4) | Waist circumference |
| 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 |
| 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 |
| Diary outcomes (1) | T=-1 (start study) until T=4 weeks after vaccination (end of study) | General illness |
| Diary outcomes (2) | T=0 (day before vaccination) until T=4 weeks after vaccination (end of study) | Side effects COVID-19 vaccine |
| Diary outcomes (3) | T=-1 (start study) until T=4 weeks after vaccination (end of study) | Medication intake |
| Anthropometry (2) | T=-1 (start study) | Height |
Countries
Netherlands
Outcome results
None listed