The Effects of Long-term Daily Plant Stanol Ester Intake on Clinical Symptoms in Individuals With Allergic Asthma: an Exploratory Double-blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Asthma control questionnaire score
研究概览
简要总结
Plant stanols are known to lower low-density lipoprotein cholesterol. However, studies have suggested that these compounds also influence the immune system. Asthmatic responses are predominantly T helper (Th)2 cell dependent, while plant stanols were previously found to activate Th1 cells and shift the immune response away from the Th2 cell dominant asthmatic response. The question now is whether this also translates into a reduction of clinical symptoms in asthma patients.The primary objective of this study is to demonstrate clinical benefits of prolonged consumption of plant stanols (delivered via plant stanol esters) in asthma patients. The secondary objectives are to evaluate the mechanisms via which plant stanols modulate the immune system and to evaluate the effects of plant stanol ester consumption on cardiovascular (CVD) risk parameters.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with allergic asthma (GINA step 1-4) which is in a stable phase at the moment of inclusion (defined as no changes in asthma control and lung function in (at least) the past three months)
- •Have been treated with prescribed asthma medication for at least one year
- •Aged 18-70 years old
- •BMI between 20 and 35 kg/m2
- •Willing to abstain from products containing plant sterols or stanols one month prior to the study (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 supplements constant
排除标准
- •Currently smoking or quitted smoking in the past year, with a maximum of 10 packyears as smoking history (packyears = packs per day * years of smoking)
- •Allergy to an ingredient of the soft chews
- •Suffering from inflammatory diseases (for CVD, illness must be minimally 3 years ago and currently under control in order to participate in the study)
- •Fasting plasma glucose > 7.0 mmol/L
- •Fasting serum TC > 8.0 mmol/L
- •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
研究组 & 干预措施
Plant stanol group
This arm receives soft chews containing 0.5g of plant stanols (delivered as plant stanol esters).
干预措施: Soft chews containing 0.5g plant stanols (delivered as plant stanol esters) (Dietary Supplement)
Placebo group
This arm receives soft chews that do not contain 0.5g of plant stanols (delivered as plant stanol esters).
干预措施: Placebo soft chew (Dietary Supplement)
结局指标
主要结局
Asthma control questionnaire score
时间窗: Change between T=0 months and T=12 months
The ACQ consists of seven questions: five questions are on asthma related symptoms, one on medication use and one on the FEV1. Participants are asked to score their symptoms and medication use of the past week on a scale from zero to six. The score of the ACQ is the average score on the seven questions. A score of zero means that asthma is fully controlled; a score of six means that asthma is severely uncontrolled. The minimal clinically important difference is 0.5. The ACQ has been validated and is widely use in research and clinical settings.
次要结局
- Immune parameters (4)(T=0 months, T=3 months, T=6 months, T=9 months, T=12 months)
- Asthma control questionnaire score(T=0 months, T=3 months, T=6 months, T=9 months, T=12 months)
- Leukocyte count(T=0 months, T=3 months, T=6 months, T=9 months, T=12 months)
- Leukocyte differential count(T=0 months, T=3 months, T=6 months, T=9 months, T=12 months)
- Duration of exacerbations(Throughout 1 year)
- Fasted metabolism (1)(T=0 months, T=3 months, T=6 months, T=9 months, T=12 months)
- Fasted metabolism (3)(T=0 months, T=3 months, T=6 months, T=9 months, T=12 months)
- Vascular function markers (2)(T=0 months and T=12 months)
- Forced expiratory volume in 1 second(T=0 months, T=3 months, T=6 months, T=9 months, T=12 months)
- Incidence counts of exacerbations and other asthma related complaints(Throughout 1 year)
- Severity of exacerbations(Throughout 1 year)
- Red blood cell count(T=0 months, T=3 months, T=6 months, T=9 months, T=12 months)
- Platelet count(T=0 months, T=3 months, T=6 months, T=9 months, T=12 months)
- Hemoglobin(T=0 months, T=3 months, T=6 months, T=9 months, T=12 months)
- Forced vital capacity(T=0 months, T=3 months, T=6 months, T=9 months, T=12 months)
- Number of visits to the general practitioner or hospital(Throughout 1 year)
- Calculated disease load(Throughout 1 year)
- Number of infections that occur throughout the study(Throughout 1 year)
- Hematocrit(T=0 months, T=3 months, T=6 months, T=9 months, T=12 months)
- Immune parameters (2)(T=0 months, T=3 months, T=6 months, T=9 months, T=12 months)
- Anthropometry (1)(T=0 months, T=3 months, T=6 months, T=9 months, T=12 months)
- Diet(T=0 months, T=6 months, T=12 months)
- Vascular function markers (1)(T=0 months and T=12 months)
- Asthma related medication use(Throughout 1 year)
- Anthropometry (6)(T=0 months, T=3 months, T=6 months, T=9 months, T=12 months)
- Immune parameters (1)(T=0 months, T=6 months, T=12 months)
- Anthropometry (4)(T=0 months, T=3 months, T=6 months, T=9 months, T=12 months)
- Immune cell characterisation(T=0 months, T=6 months, T=12 months)
- Immune parameters (3)(T=0 months, T=3 months, T=6 months, T=9 months, T=12 months)
- Fasted metabolism (2)(T=0 months, T=3 months, T=6 months, T=9 months, T=12 months)
- Vascular function markers (3)(T=0 months and T=12 months)
- Fatigue(T=0 months, T=3 months, T=6 months, T=9 months, T=12 months)
- Physical activity(T=0 months, T=3 months, T=6 months, T=9 months, T=12 months)
- Mood(T=0 months, T=3 months, T=6 months, T=9 months, T=12 months)
- Cardiometabolic risk marker(T=0 months and T=12 months)
- Cognitive function(T=0 months and T=12 months)
- Anthropometry (2)(T=0 months, T=3 months, T=6 months, T=9 months, T=12 months)
- Anthropometry (3)(T=0 months, T=3 months, T=6 months, T=9 months, T=12 months)
- Anthropometry (5)(T=0 months, T=3 months, T=6 months, T=9 months, T=12 months)
- Quality of life score(T=0 months, T=3 months, T=6 months, T=9 months, T=12 months)