NCT04844346 is a NA clinical trial of Plant stanol mini drinks in Overweight and Obesity, sponsored by Maastricht University Medical Center.

Who is sponsoring NCT04844346?

NCT04844346 is sponsored by Maastricht University Medical Center.

What drugs are being tested in NCT04844346?

Interventions in NCT04844346: Plant stanol mini drinks, Placebo mini drinks, COVID-19 vaccine.

What condition does NCT04844346 study?

NCT04844346 studies Overweight and Obesity.

Is NCT04844346 still recruiting?

NCT04844346 is currently terminated. Last updated 2 March 2022.

Last reviewed 2022-03-02 · How we verify

NCT04844346

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Plant Stanol Esters and COVID-19 Vaccination Response

Terminated NA Last updated 2 March 2022

What this trial tests

NA trial testing Plant stanol mini drinks in Overweight and Obesity in 48 participants. Terminated before completion.

Timeline

22 April 2021

Primary endpoint
11 January 2022

11 January 2022

Quick facts

Lead sponsor	Maastricht University Medical Center
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	48
Start date	22 April 2021
Primary completion	11 January 2022
Estimated completion	11 January 2022
Sites	1 location across Netherlands

Drugs / interventions tested

Plant stanol mini drinks
Placebo mini drinks
COVID-19 vaccine (COVID-19 Vaccine) — full drug profile →

Conditions studied

Overweight and Obesity — all drugs for Overweight and Obesity →

Sponsor

Maastricht University Medical Center

Who can join

18 and older, any sex, with Overweight and Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Efficacy and safety of COVID-19 vaccines.
Graña C, Ghosn L, Evrenoglou T, Jarde A, et al · · 2022 · cited 227× · PMID 36473651 · DOI 10.1002/14651858.cd015477
Plant stanol consumption increases anti-COVID-19 antibody responses, independent of changes in serum cholesterol concentrations: a randomized controlled trial.
van Brakel L, Mensink RP, Lütjohann D, Plat J. · · 2024 · cited 4× · PMID 38278364 · DOI 10.1016/j.ajcnut.2024.01.017
Plant stanol esters might optimise the immune response and improve the SARS-CoV-2/COVID-19 vaccine efficacy in overweight and obese subjects.
Plat J, van Brakel L, Mensink RP. · · 2022 · cited 1× · PMID 34044900 · DOI 10.1017/s0007114521001781

Verify or expand the search:

Other recruiting trials for Overweight and Obesity

Currently open trials in the same condition.

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NCT07165431 — Effect of a Postbiotic Supplementation in Overweight and Obese Subjects: A Randomized Controlled Trial (PARABIOTICS-2). · NA · recruiting

Other Maastricht University Medical Center trials

Trials by the same sponsor.

NCT04603261 — Time to Excretion of Contrast, a Maastricht Prospective Observational Study · withdrawn
NCT04598516 — Maastricht Investigation of Renal Function in Absence of- and Post- Contrast in Patients With eGFR LEss Than 30 · withdrawn
NCT04597892 — Efficacy of Point-Of-Care Creatinine Assays in Patients With eGFR <30 Receiving Intravascular Contrast · withdrawn
NCT07287358 — Optimal Cerebral Perfusion Pressure Guided Therapy: Assessment of Target Effectiveness - II · NA · not yet recruiting
NCT07501780 — Real-world Evaluation of the Implementation of LC-OCT in Daily Clinical Practice · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04844346 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Maastricht University Medical Center
Last refreshed: 2 March 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04844346.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing