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Plant Stanol Esters and COVID-19 Vaccination Response

Primary Purpose

Overweight and Obesity

Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Plant stanol mini drinks
Placebo mini drinks
COVID-19 vaccine
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight and Obesity focused on measuring Overweight, Obesity, COVID-19 vaccine, Immune system, Vaccination response

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Maastricht University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Plant stanol group

Placebo group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Immune parameters (1)
Cytokine production by PBMCs after stimulation with antiCD3-antiCD28 antiCD28 antibodies using the TruCulture system
Immune parameters (2)
hsCRP
Leukocyte count
Number of leukocytes measured in EDTA plasma
Leukocyte differential count
Number of subgroups of leukocytes measured in EDTA plasma
Fasted metabolism (1)
Serum non-cholesterol sterols and stanols
Fasted metabolism (2)
Serum lipid and lipoprotein profile
Fasted metabolism (3)
Glucose metabolism (including e.g. plasma glucose, serum insulin and calculated HOMA-IR)
Anthropometry (1)
Body weight
Anthropometry (2)
Height
Anthropometry (3)
Waist circumference
Anthropometry (4)
Hip circumference
Anthropometry (5)
Waist-to-hip ratio
Diet
Food frequency questionnaire is used to determine if the participants maintain their habitual diet and to determine if the participants do not consume plant stanols and/or sterols outside the intervention
Diary outcomes (1)
General illness
Diary outcomes (2)
Side effects COVID-19 vaccine
Diary outcomes (3)
Medication intake

Full Information

First Posted
April 13, 2021
Last Updated
February 11, 2022
Sponsor
Maastricht University Medical Center
Collaborators
Raisio Nutrition Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04844346
Brief Title
Plant Stanol Esters and COVID-19 Vaccination Response
Official Title
The Effect of Plant Stanol Ester Consumption on the Vaccination Response to a COVID-19 Vaccine
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
Recruitment was dependent on finding participants that had to receive an initial COVID-19 vaccination and we were unable to find new participants anymore.
Study Start Date
April 22, 2021 (Actual)
Primary Completion Date
January 11, 2022 (Actual)
Study Completion Date
January 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Raisio Nutrition Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Overweight, Obesity, COVID-19 vaccine, Immune system, Vaccination response

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Plant stanol group
Arm Type
Experimental
Arm Description
This arm receives 4g of plant stanols per day (delivered as plant stanol esters) by consuming mini drinks (100 mL each).
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
This arm receives mini drinks without added plant stanols (delivered as plant stanol esters).
Intervention Type
Dietary Supplement
Intervention Name(s)
Plant stanol mini drinks
Intervention Description
Oat milk based mini drinks (100 mL) containing 2g plant stanols each (delivered as plant stanol esters).
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo mini drinks
Intervention Description
Oat milk based mini drinks (100 mL) without added plant stanols (delivered as plant stanol esters).
Intervention Type
Biological
Intervention Name(s)
COVID-19 vaccine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Vaccine specific antibody titers
Description
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.
Time Frame
Change T=0 and T= 4 weeks
Secondary Outcome Measure Information:
Title
Immune parameters (1)
Description
Cytokine production by PBMCs after stimulation with antiCD3-antiCD28 antiCD28 antibodies using the TruCulture system
Time Frame
T=-1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination
Title
Immune parameters (2)
Description
hsCRP
Time Frame
T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Title
Leukocyte count
Description
Number of leukocytes measured in EDTA plasma
Time Frame
T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Title
Leukocyte differential count
Description
Number of subgroups of leukocytes measured in EDTA plasma
Time Frame
T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Title
Fasted metabolism (1)
Description
Serum non-cholesterol sterols and stanols
Time Frame
T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Title
Fasted metabolism (2)
Description
Serum lipid and lipoprotein profile
Time Frame
T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Title
Fasted metabolism (3)
Description
Glucose metabolism (including e.g. plasma glucose, serum insulin and calculated HOMA-IR)
Time Frame
T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Title
Anthropometry (1)
Description
Body weight
Time Frame
T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Title
Anthropometry (2)
Description
Height
Time Frame
T=-1 (start study)
Title
Anthropometry (3)
Description
Waist circumference
Time Frame
T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Title
Anthropometry (4)
Description
Hip circumference
Time Frame
T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Title
Anthropometry (5)
Description
Waist-to-hip ratio
Time Frame
T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Title
Diet
Description
Food frequency questionnaire is used to determine if the participants maintain their habitual diet and to determine if the participants do not consume plant stanols and/or sterols outside the intervention
Time Frame
T=-1 (start study) and T=4 weeks after vaccination (end study)
Title
Diary outcomes (1)
Description
General illness
Time Frame
T=-1 (start study) until T=4 weeks after vaccination (end of study)
Title
Diary outcomes (2)
Description
Side effects COVID-19 vaccine
Time Frame
T=0 (day before vaccination) until T=4 weeks after vaccination (end of study)
Title
Diary outcomes (3)
Description
Medication intake
Time Frame
T=-1 (start study) until T=4 weeks after vaccination (end of study)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jogchum Plat, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ronald P Mensink, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229ER
Country
Netherlands

12. IPD Sharing Statement

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Plant Stanol Esters and COVID-19 Vaccination Response

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