The primary objective of this study is to demonstrate the effect of consuming different daily amounts of plant stanols (2.0, 3.0, or 4.0 gr stanols; delivered via products enriched with plant stanol esters) on the vaccination response to an…
ID
Source
Brief title
Condition
- Lipid metabolism disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study outcome is the vaccination response to the influenza vaccine.
Secondary outcome
Secondary endpoints include amongst others, hematological, inflammatory and
immunological parameters (e.g. hs-CRP, leukocyte differential count, cytokines)
and metabolic markers (e.g. blood lipid profiles, plasma glucose).
Background summary
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 effect on the immune system,
people with overweight or obesity and higher age might benefit from consuming
plant stanols prior to receiving the influenza vaccination. In our earlier
vaccination studies participants consumed 4.0 gr plant stanol per day, however
we do not know if that intake is required or can similar effects be achieved
with lower intakes.
Study objective
The primary objective of this study is to demonstrate the effect of consuming
different daily amounts of plant stanols (2.0, 3.0, or 4.0 gr stanols;
delivered via products enriched with plant stanol esters) on the vaccination
response to an influenza vaccine in men and women aged 60 years or older during
the influenza season 2022/2023.
Study design
A double-blind, randomized, placebo-controlled trial will be carried out. The
intervention period lasts at least 6 weeks.
Intervention
The intervention groups will receive soft chews containing 0.5 gr plant stanols
per chew (present as plant stanol esters esterified to rapeseed oil fatty
acids) and are required to take 4, 6 or 8 chews daily in order to reach a
required dose of 2.0, 3.0, or 4.0 gr plant stanols per day, respectively. The
control group will receive 6 control chews per day containing no plant stanols
but polyols and rapeseed oil fatty acids. Both chews are lemon flavored. The
chews shall be consumed with daily meals.
Study burden and risks
Subjects will be screened via telephone to determine eligibility. If a subject
fulfills all criteria, a baseline visit is planned where the informed consent
is obtained at the start. If the consent form is signed, a baseline blood
sample will be taken and subjects will start consuming the soft chews until
their influenza vaccination. This means that the time period between the start
of consuming the plant stanol ester enriched products and the actual
vaccination might slightly differ between participants, but the targeted period
for consumption of the test chews is 24 weeks prior to the receiving the
vaccination. Volunteers will be asked to visit the university for a fasting
blood sample the day before the vaccination. Following the influenza
vaccination, study participants will continue to consume the test chews and
will visit the study site weekly for blood sampling for 4 additional weeks. The
test chews shall be consumed as part of daily meals. There are no direct
benefits for study subjects. The intervention and control soft chews are
considered to be safe. Some study subjects may report pain during venipuncture.
Subjects that do not fully adhere to the study protocol will be excluded from
analyses and a per protocol analysis will be performed. Time investment per
participant will be approximately 3 hours in total. This estimation excludes
travel time. The total blood sampling volume over the entire study period will
be approximately 78 mL.
Universiteitssingel 50
Maastricht 6229 ER
NL
Universiteitssingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
60 years or older in influenza season (2022/2023), BMI 20-35 kg/m2, not using
products with added plant sterols or plant stanols,
willing to abstain from products with added plant sterols or plant stanols
during study, willing to keep intake of fish
oil and vitamin supplements constant during study
Exclusion criteria
Already received influenza vaccination, already had influenza in 2022, allergy
to an ingredient of the soft chews, excessive alcohol use (>20 consumptions per
week),
regular use of drugs, blood donors that want to donate one month prior to or
during the study, Known allergic reaction to an active component or other
components of the vaccine (e.g. chicken eggs)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05706350 |
| CCMO | NL82182.068.22 |