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Evaluating the effect of different daily plant stanol ester intakes on the vaccination response to an influenza vaccine

Evaluating the effect of different daily plant stanol ester intakes on the vaccination response to an influenza vaccine - Plant stanol esters and influenza vaccination response

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53853
Enrollment
215
Registered
2022-10-03
Start date
2022-10-11
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decreased immune response

Interventions

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 ch

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
Main study outcome is the vaccination response to the influenza vaccine.

Secondary

MeasureTime frame
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).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)