Plant Stanol Esters and COVID-19 Vaccination Response

Overweight and Obesity Clinical Trial

Official title:

The Effect of Plant Stanol Ester Consumption on the Vaccination Response to a COVID-19 Vaccine

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04844346
• Other study ID #: METC 21-013
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• COVID-19
• Overweight
• Overweight and Obesity

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)