Plant Stanol Esters and COVID-19 Vaccination Response

NCT04844346 | Terminated

• 1 other identifier: METC 21-013
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Overweight; Obesity; COVID-19 vaccine; Immune system; Vaccination response

Outcome Measures

Primary Outcomes (1)

• Vaccine specific antibody titers

  The response to the COVID-19 vaccine will be measured by quantifying specific antibody titers (vaccine specific IgG and IgM). These titers will be measured in blood samples collected weekly during the month after vaccination by suitable ELISAs.

  Change T=0 and T= 4 weeks

Secondary Outcomes (16)

• Immune parameters (1)

  T=-1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination

• Immune parameters (2)

  T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)

• Leukocyte count

  T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)

• Leukocyte differential count

  T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)

• Fasted metabolism (1)

  T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)

Study Arms (2)

Plant stanol group

EXPERIMENTAL

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

Dietary Supplement: Plant stanol mini drinks; Biological: COVID-19 vaccine

Placebo group

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo mini drinks; Biological: COVID-19 vaccine

Interventions

Plant stanol mini drinks DIETARY_SUPPLEMENT

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

Plant stanol group

Placebo mini drinks DIETARY_SUPPLEMENT

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

Placebo group

COVID-19 vaccine 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; Plant stanol group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Raisio Nutrition Ltd.: collaborator

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229ER, Netherlands

Location

Related Publications (1)

• van Brakel L, Mensink RP, Lutjohann D, Plat J. Plant stanol consumption increases anti-COVID-19 antibody responses, independent of changes in serum cholesterol concentrations: a randomized controlled trial. Am J Clin Nutr. 2024 Apr;119(4):969-980. doi: 10.1016/j.ajcnut.2024.01.017. Epub 2024 Jan 24.

  PMID: 38278364 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Jogchum Plat, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

• Ronald P Mensink, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 14, 2021
• Study Start: April 22, 2021
• Primary Completion: January 11, 2022
• Study Completion: January 11, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-02

Locations

NL (1)