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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, recent studies have suggested that these compounds also beneficially influence the immune system, e.g. increasing vaccine-specific antibody titers. BMI and age have previously been negatively associated to vaccination responses. If plant stanols indeed have beneficial effects on the immune system, people with overweight or obesity and higher age might benefit from consuming plant stanols prior to receiving the influenza vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plant stanol group (2 grams per day) | Experimental | Dietary Supplement: 4 soft chews containing 0.5g plant stanols each (delivered as plant stanol esters) Soft chews containing 0.5g plant stanols each delivered as plant stanol esters |
|
| Plant stanol group (3 grams per day) | Experimental | Dietary Supplement: 6 soft chews containing 0.5g plant stanols each (delivered as plant stanol esters) Soft chews containing 0.5g plant stanols each delivered as plant stanol esters |
|
| Plant stanol group (4 grams per day) | Experimental | Dietary Supplement: 8 soft chews containing 0.5g plant stanols each (delivered as plant stanol esters) Soft chews containing 0.5g plant stanols each delivered as plant stanol esters |
|
| Placebo group | Placebo Comparator | Dietary Supplement: 6 placebo soft chews Soft chews that do not contain plant stanols |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza vaccine | Biological | Single dose of the Influenza vaccine Participants have to wait until they are invited to receive the vaccine by the general practitioner; this study does not interfere with national planning of the vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Vaccine specific IgM antibody titer | The response to the Influenza vaccine will be measured by quantifying the specific IgM antibody titer | Maximal change from T=0 (change T=0 to T=3 weeks or T=4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Vaccine specific IgG antibody titer | The response to the Influenza vaccine will be measured by quantifying the specific IgG antibody titer | T=0 (day before vaccination), weekly in the month after vaccination (T1-T4) |
| Immune parameters (1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center | Maastricht | Limburg | 6229ER | Netherlands |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Plant stanol soft chews (2g per day) | Dietary Supplement | Participants have to consume 4 soft chews per day containing 0.5g plant stanols each (delivered as plant stanol esters), corresponding to a total plant stanol intake of 2g daily |
|
| Plant stanol soft chews (3g per day) | Dietary Supplement | Participants have to consume 6 soft chews per day containing 0.5g plant stanols each (delivered as plant stanol esters), corresponding to a total plant stanol intake of 3g daily |
|
| Plant stanol soft chews (4g per day) | Dietary Supplement | Participants have to consume 8 soft chews per day containing 0.5g plant stanols each (delivered as plant stanol esters), corresponding to a total plant stanol intake of 4g daily |
|
| Control soft chews | Dietary Supplement | Participants have to consume 6 control soft chews per day that does not contain plant stanols |
|
Cytokine production by PBMCs after stimulation with antiCD3-antiCD28 antiCD28 antibodies using the TruCulture system
| Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study) |
| Immune parameters (2) | hsCRP | Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study) |
| Leukocyte count | Number of leukocytes measured in EDTA plasma | Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study) |
| Leukocyte differential count | Number of subgroups of leukocytes measured in EDTA plasma | Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study) |
| Fasted metabolism (1) | Serum non-cholesterol sterols and stanols | Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study) |
| Fasted metabolism (2) | Serum lipid and lipoprotein profile | Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study) |
| Fasted metabolism (3) | Plasma glucose | Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study) |
| Anthropometry (1) | Body weight | Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4) |
| Anthropometry (2) | Height | Day - 1 (start study) |
| Anthropometry (3) | Waist circumference | Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4) |
| Anthropometry (4) | Hip circumference | Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4) |
| Anthropometry (5) | Waist-to-hip ratio | Day - 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 | Day - 1 (start study), T=4 weeks after vaccination (end of study) |
| Liver elastography | Fibroscan | Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study) |
| Liver fat content | Fibroscan | Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study) |
| Diary outcomes (1) | Adverse events as assessed by the diary | Day - 1 (start study), T=4 weeks after vaccination (end of study) |
| Diary outcomes (2) | Medication intake as assessed by the diary | Day - 1 (start study), T=4 weeks after vaccination (end of study) |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |