MedTrace Logo

Plant Stanol Esters and COVID-19 Vaccination Response

NCT04844346 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2022-03-02

No results posted yet for this study

Summary

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).

Conditions

  • Overweight and Obesity

Interventions

DIETARY_SUPPLEMENT

Plant stanol mini drinks

Oat milk based mini drinks (100 mL) containing 2g plant stanols each (delivered as plant stanol esters).

DIETARY_SUPPLEMENT

Placebo mini drinks

Oat milk based mini drinks (100 mL) without added plant stanols (delivered as plant stanol esters).

BIOLOGICAL

COVID-19 vaccine

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.

Sponsors & Collaborators

  • Raisio Nutrition Ltd.

    collaborator UNKNOWN

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Jogchum Plat, PhD · Maastricht University Medical Center

  • Ronald P Mensink, PhD · Maastricht University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-22
Primary Completion
2022-01-11
Completion
2022-01-11

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04844346 on ClinicalTrials.gov