Plant Stanol Esters and Preventing Asthma Symptoms
- Conditions
- Asthma, AllergicCardiovascular Diseases
- Interventions
- Dietary Supplement: Placebo soft chewDietary Supplement: Soft chews containing 0.5g plant stanols (delivered as plant stanol esters)
- Registration Number
- NCT03983603
- Lead Sponsor
- Maastricht University Medical Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 160
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo group Placebo soft chew This arm receives soft chews that do not contain 0.5g of plant stanols (delivered as plant stanol esters). Plant stanol group Soft chews containing 0.5g plant stanols (delivered as plant stanol esters) This arm receives soft chews containing 0.5g of plant stanols (delivered as plant stanol esters).
- Primary Outcome Measures
Name Time Method Asthma control questionnaire score 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.
- Secondary Outcome Measures
Name Time Method Vascular function markers (1) T=0 months and T=12 months Carotid-femoral pulse wave velocity (PWV)
Asthma control questionnaire score T=0 months, T=3 months, T=6 months, T=9 months, 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.
Leukocyte count T=0 months, T=3 months, T=6 months, T=9 months, T=12 months Number of leukocytes measured in EDTA plasma
Leukocyte differential count T=0 months, T=3 months, T=6 months, T=9 months, T=12 months Number of subgroups of leukocytes measured in EDTA plasma
Duration of exacerbations Throughout 1 year Self-reported duration of exacerbations
Fasted metabolism (1) T=0 months, T=3 months, T=6 months, T=9 months, T=12 months Serum lipid and lipoprotein profile
Fasted metabolism (3) T=0 months, T=3 months, T=6 months, T=9 months, T=12 months Plasma glucose metabolism
Vascular function markers (2) T=0 months and T=12 months Pulse wave analysis (PWA)
Forced expiratory volume in 1 second T=0 months, T=3 months, T=6 months, T=9 months, T=12 months Amount of air that can be exhaled forcefully in one second in Liters or %
Incidence counts of exacerbations and other asthma related complaints Throughout 1 year Self-reported amount of exacerbations and other asthma related complaints
Severity of exacerbations Throughout 1 year Self-reported severity of exacerbations
Red blood cell count T=0 months, T=3 months, T=6 months, T=9 months, T=12 months Number of red blood cells measured in EDTA plasma
Platelet count T=0 months, T=3 months, T=6 months, T=9 months, T=12 months Number of platelets measured in EDTA plasma
Hemoglobin T=0 months, T=3 months, T=6 months, T=9 months, T=12 months Hemoglobin measured in EDTA plasma
Forced vital capacity T=0 months, T=3 months, T=6 months, T=9 months, T=12 months Amount of air that can be exhaled forcefully in total in Liters or %
Number of visits to the general practitioner or hospital Throughout 1 year Self-reported amount of visits to the general practitioner or hospital
Calculated disease load Throughout 1 year Number x duration of exacerbations
Number of infections that occur throughout the study Throughout 1 year Self-reported amount of infections
Hematocrit T=0 months, T=3 months, T=6 months, T=9 months, T=12 months Hematocrit measured in EDTA plasma
Immune parameters (2) T=0 months, T=3 months, T=6 months, T=9 months, T=12 months Total IgE
Immune parameters (4) T=0 months, T=3 months, T=6 months, T=9 months, T=12 months hsCRP
Anthropometry (1) T=0 months, T=3 months, T=6 months, T=9 months, T=12 months Body weight
Diet T=0 months, T=6 months, T=12 months 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
Asthma related medication use Throughout 1 year Self-reported medication use
Anthropometry (6) T=0 months, T=3 months, T=6 months, T=9 months, T=12 months Waist-to-hip ratio
Immune parameters (1) T=0 months, T=6 months, T=12 months Cytokine production by PBMCs after stimulation with antiCD3-antiCD28 antiCD28 antibodies using the TruCulture system
Anthropometry (4) T=0 months, T=3 months, T=6 months, T=9 months, T=12 months Waist circumference
Immune cell characterisation T=0 months, T=6 months, T=12 months Fluorescence-activated cell sorting (FACS)
Immune parameters (3) T=0 months, T=3 months, T=6 months, T=9 months, T=12 months Total IgM
Fasted metabolism (2) T=0 months, T=3 months, T=6 months, T=9 months, T=12 months Serum non-cholesterol sterols and stanols
Vascular function markers (3) T=0 months and T=12 months Retinal microvascular caliber
Fatigue T=0 months, T=3 months, T=6 months, T=9 months, T=12 months Fatigue severity score (FSS), a 9-item questionnaire is used to determine the severity of fatigue a subject experienced in the past week during daily activities
Physical activity T=0 months, T=3 months, T=6 months, T=9 months, T=12 months Baecke's questionnaire
Mood T=0 months, T=3 months, T=6 months, T=9 months, T=12 months Affect grid
Cardiometabolic risk marker T=0 months and T=12 months Office blood pressure
Cognitive function T=0 months and T=12 months CANTAB tests
Anthropometry (2) T=0 months, T=3 months, T=6 months, T=9 months, T=12 months Height
Anthropometry (3) T=0 months, T=3 months, T=6 months, T=9 months, T=12 months Body mass index
Anthropometry (5) T=0 months, T=3 months, T=6 months, T=9 months, T=12 months Hip circumference
Quality of life score T=0 months, T=3 months, T=6 months, T=9 months, T=12 months 32-item questionnaire (including social, spiritual, emotional, cognitive, physical, activities of daily living, and integrated Quality of Life)
Trial Locations
- Locations (1)
Maastricht University Medical Center
🇳🇱Maastricht, Limburg, Netherlands