Plant Stanol Esters and COVID-19 Vaccination Response

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-22

Study Completion Date

2022-01-11

Brief Summary

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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).

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Detailed Description

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Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Plant stanol group

This arm receives 4g of plant stanols per day (delivered as plant stanol esters) by consuming mini drinks (100 mL each).

Group Type EXPERIMENTAL

Plant stanol mini drinks

Intervention Type DIETARY_SUPPLEMENT

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

COVID-19 vaccine

Intervention Type BIOLOGICAL

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.

Placebo group

This arm receives mini drinks without added plant stanols (delivered as plant stanol esters).

Group Type PLACEBO_COMPARATOR

Placebo mini drinks

Intervention Type DIETARY_SUPPLEMENT

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

COVID-19 vaccine

Intervention Type BIOLOGICAL

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.

Interventions

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Plant stanol mini drinks

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

Intervention Type DIETARY_SUPPLEMENT

Placebo mini drinks

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

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Men and women
* Aged 18 years or older
* BMI between 27 and 35 kg/m2
* Currently not using products containing plant sterols or stanols (products with a cholesterol lowering claim of Becel ProActiv, Benecol, Danacol, store brands)
* Willing to abstain from products containing plant sterols or stanols during the study (products with a cholesterol lowering claim of Becel ProActiv, Benecol, Danacol, store brands)
* Willing to keep the intake of fish oil and vitamin supplements constant

Exclusion Criteria

* Already received COVID-19 vaccination
* Already had a positive test for COVID-19 (this includes all types of tests, e.g. PCR tests or antibody tests)
* Allergy to an ingredient of the mini drinks
* Having donated blood within one month prior to the start of the study, or planning to donate blood during the study
* Pregnant women
* Breastfeeding women
* Excessive alcohol use (\>20 consumptions per week)
* Regular use of soft or hard drugs

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes