The Effect of Plant Stanol Ester Consumption on the Vaccination Response to a COVID-19 Vaccine
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Vaccine specific antibody titers
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Vaccine specific antibody titers
时间窗: Change T=0 and T= 4 weeks
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.
次要结局
- Immune parameters (2)(T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4))
- Fasted metabolism (2)(T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4))
- Anthropometry (1)(T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4))
- Immune parameters (1)(T=-1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination)
- Leukocyte count(T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4))
- Anthropometry (2)(T=-1 (start study))
- Diary outcomes (2)(T=0 (day before vaccination) until T=4 weeks after vaccination (end of study))
- Fasted metabolism (1)(T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4))
- Anthropometry (3)(T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4))
- Diary outcomes (1)(T=-1 (start study) until T=4 weeks after vaccination (end of study))
- Diary outcomes (3)(T=-1 (start study) until T=4 weeks after vaccination (end of study))
- Fasted metabolism (3)(T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4))
- Diet(T=-1 (start study) and T=4 weeks after vaccination (end study))
- Leukocyte differential count(T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4))
- Anthropometry (4)(T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4))
- Anthropometry (5)(T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4))