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The effect of plant stanol ester consumption on the vaccination response to a COVID-19 vaccine

The effect of plant stanol ester consumption on the vaccination response to a COVID-19 vaccine - Plant stanol esters and COVID-19 vaccination response

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51220
Enrollment
100
Registered
2021-03-18
Start date
2021-04-22
Completion date
Unknown
Last updated
2024-04-09

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

Conditions

obesity Overweight

Interventions

The intervention group will receive mini drinks (100 mL) containing 2g plant stanols each (present as plant stanol esters esterified to rapeseed oil) and are required to take two drinks daily in ord

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Men and women, 18 years or older, BMI 27-35 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 COVID-19 vaccination, already had a positive test for COVID-19 (all tests, e.g. PCR test or antibody test), allergy to an ingredient of the mini drinks, 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, pregnant or breastfeeding women

Design outcomes

Primary

MeasureTime frame
The main study endpoint is vaccination response to a COVID-19 vaccine.

Secondary

MeasureTime frame
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).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)