NCT05706350已完成不适用
Evaluating the Effect of Different Daily Plant Stanol Ester Intakes on the Vaccination Response to an Influenza Vaccine
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 2
- 主要终点
- Vaccine specific IgM antibody titer
研究概览
简要总结
Plant stanols are known to lower low-density lipoprotein cholesterol (LDL-C). However, recent studies have suggested that these compounds also beneficially influence the immune system, e.g. increasing vaccine-specific antibody titers. BMI and age have previously been negatively associated to vaccination responses. If plant stanols indeed have beneficial effects on the immune system, people with overweight or obesity and higher age might benefit from consuming plant stanols prior to receiving the influenza vaccination.
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
- 59 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women
- •Aged 60 years or older (or 59, but turning 60 years during influenza season 2022/2023 (in line with RIVM guidelines))
- •BMI between 20 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 influenza vaccination in 2022
- •Already had influenza in 2022
- •Allergy to an ingredient of the chews
- •Having donated blood within one month prior to the start of the study, or planning to donate blood during the study
- •Excessive alcohol use (>20 consumptions per week)
- •Regular use of soft and/or hard drugs
结局指标
主要结局
Vaccine specific IgM antibody titer
时间窗: Maximal change from T=0 (change T=0 to T=3 weeks or T=4 weeks)
The response to the Influenza vaccine will be measured by quantifying the specific IgM antibody titer
次要结局
- Immune parameters (1)(Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study))
- Leukocyte differential count(Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study))
- Anthropometry (1)(Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4))
- Anthropometry (5)(Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4))
- Anthropometry (3)(Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4))
- Leukocyte count(Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study))
- Fasted metabolism (2)(Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study))
- Fasted metabolism (3)(Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study))
- Anthropometry (4)(Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4))
- Diet(Day - 1 (start study), T=4 weeks after vaccination (end of study))
- Vaccine specific IgG antibody titer(T=0 (day before vaccination), weekly in the month after vaccination (T1-T4))
- Immune parameters (2)(Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study))
- Fasted metabolism (1)(Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study))
- Diary outcomes (2)(Day - 1 (start study), T=4 weeks after vaccination (end of study))
- Anthropometry (2)(Day - 1 (start study))
- Liver elastography(Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study))
- Liver fat content(Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study))
- Diary outcomes (1)(Day - 1 (start study), T=4 weeks after vaccination (end of study))
研究者
研究点 (2)
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