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Recruitment was dependent on finding participants that had to receive an initial COVID-19 vaccination and we were unable to find new participants anymore.
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| Name | Class |
|---|---|
| Raisio Nutrition Ltd. | UNKNOWN |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plant stanol group | Experimental | This arm receives 4g of plant stanols per day (delivered as plant stanol esters) by consuming mini drinks (100 mL each). |
|
| Placebo group | Placebo Comparator | This arm receives mini drinks without added plant stanols (delivered as plant stanol esters). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plant stanol mini drinks | Dietary Supplement | Oat milk based mini drinks (100 mL) containing 2g plant stanols each (delivered as plant stanol esters). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vaccine specific antibody titers | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Immune parameters (1) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jogchum Plat, PhD | Maastricht University Medical Center | Principal Investigator |
| Ronald P Mensink, PhD | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center | Maastricht | Limburg | 6229ER | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38278364 | Derived | van Brakel L, Mensink RP, Lutjohann D, Plat J. Plant stanol consumption increases anti-COVID-19 antibody responses, independent of changes in serum cholesterol concentrations: a randomized controlled trial. Am J Clin Nutr. 2024 Apr;119(4):969-980. doi: 10.1016/j.ajcnut.2024.01.017. Epub 2024 Jan 24. |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D000086663 | COVID-19 Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Placebo mini drinks | Dietary Supplement | Oat milk based mini drinks (100 mL) without added plant stanols (delivered as plant stanol esters). |
|
| COVID-19 vaccine | Biological | 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. |
|
hsCRP
| T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4) |
| Leukocyte count | 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 | 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) | 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) | 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) | 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) | Body weight | T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4) |
| Anthropometry (2) | Height | T=-1 (start study) |
| Anthropometry (3) | Waist circumference | T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4) |
| Anthropometry (4) | Hip circumference | T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4) |
| Anthropometry (5) | Waist-to-hip ratio | T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4) |
| Diet | 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) | General illness | T=-1 (start study) until T=4 weeks after vaccination (end of study) |
| Diary outcomes (2) | Side effects COVID-19 vaccine | T=0 (day before vaccination) until T=4 weeks after vaccination (end of study) |
| Diary outcomes (3) | Medication intake | T=-1 (start study) until T=4 weeks after vaccination (end of study) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |