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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04844346
Other study ID # METC 21-013
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date April 22, 2021
Est. completion date January 11, 2022

Study information

Verified date February 2022
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Terminated
Enrollment 48
Est. completion date January 11, 2022
Est. primary completion date January 11, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Netherlands Maastricht University Medical Center Maastricht Limburg

Sponsors (2)

Lead Sponsor Collaborator
Maastricht University Medical Center Raisio Nutrition Ltd.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Immune parameters (1) Cytokine production by PBMCs after stimulation with antiCD3-antiCD28 antiCD28 antibodies using the TruCulture system T=-1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination
Secondary Immune parameters (2) hsCRP T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Secondary Leukocyte count Number of leukocytes measured in EDTA plasma T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Secondary Leukocyte differential count Number of subgroups of leukocytes measured in EDTA plasma T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Secondary Fasted metabolism (1) Serum non-cholesterol sterols and stanols T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Secondary Fasted metabolism (2) Serum lipid and lipoprotein profile T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Secondary Fasted metabolism (3) Glucose metabolism (including e.g. plasma glucose, serum insulin and calculated HOMA-IR) T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Secondary Anthropometry (1) Body weight T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Secondary Anthropometry (2) Height T=-1 (start study)
Secondary Anthropometry (3) Waist circumference T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Secondary Anthropometry (4) Hip circumference T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Secondary Anthropometry (5) Waist-to-hip ratio T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Secondary 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 T=-1 (start study) and T=4 weeks after vaccination (end study)
Secondary Diary outcomes (1) General illness T=-1 (start study) until T=4 weeks after vaccination (end of study)
Secondary Diary outcomes (2) Side effects COVID-19 vaccine T=0 (day before vaccination) until T=4 weeks after vaccination (end of study)
Secondary Diary outcomes (3) Medication intake T=-1 (start study) until T=4 weeks after vaccination (end of study)
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