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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
160
Soft chews containing 0.5g plant stanols delivered as plant stanol esters
Soft chew that does not contain plant stanols
Maastricht University Medical Center
Maastricht, Limburg, Netherlands
RECRUITINGAsthma control questionnaire score
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.
Time frame: Change between T=0 months and T=12 months
Asthma control questionnaire score
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.
Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Forced expiratory volume in 1 second
Amount of air that can be exhaled forcefully in one second in Liters or %
Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Forced vital capacity
Amount of air that can be exhaled forcefully in total in Liters or %
Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Asthma related medication use
Self-reported medication use
Time frame: Throughout 1 year
Number of visits to the general practitioner or hospital
Self-reported amount of visits to the general practitioner or hospital
Time frame: Throughout 1 year
Incidence counts of exacerbations and other asthma related complaints
Self-reported amount of exacerbations and other asthma related complaints
Time frame: Throughout 1 year
Duration of exacerbations
Self-reported duration of exacerbations
Time frame: Throughout 1 year
Severity of exacerbations
Self-reported severity of exacerbations
Time frame: Throughout 1 year
Calculated disease load
Number x duration of exacerbations
Time frame: Throughout 1 year
Number of infections that occur throughout the study
Self-reported amount of infections
Time frame: Throughout 1 year
Leukocyte count
Number of leukocytes measured in EDTA plasma
Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Leukocyte differential count
Number of subgroups of leukocytes measured in EDTA plasma
Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Red blood cell count
Number of red blood cells measured in EDTA plasma
Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Platelet count
Number of platelets measured in EDTA plasma
Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Hematocrit
Hematocrit measured in EDTA plasma
Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Hemoglobin
Hemoglobin measured in EDTA plasma
Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Immune parameters (1)
Cytokine production by PBMCs after stimulation with antiCD3-antiCD28 antiCD28 antibodies using the TruCulture system
Time frame: T=0 months, T=6 months, T=12 months
Immune parameters (2)
Total IgE
Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Immune parameters (3)
Total IgM
Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Immune parameters (4)
hsCRP
Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Fasted metabolism (1)
Serum lipid and lipoprotein profile
Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Fasted metabolism (2)
Serum non-cholesterol sterols and stanols
Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Fasted metabolism (3)
Plasma glucose metabolism
Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Vascular function markers (1)
Carotid-femoral pulse wave velocity (PWV)
Time frame: T=0 months and T=12 months
Vascular function markers (2)
Pulse wave analysis (PWA)
Time frame: T=0 months and T=12 months
Vascular function markers (3)
Retinal microvascular caliber
Time frame: T=0 months and T=12 months
Cardiometabolic risk marker
Office blood pressure
Time frame: T=0 months and T=12 months
Cognitive function
CANTAB tests
Time frame: T=0 months and T=12 months
Anthropometry (1)
Body weight
Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Anthropometry (2)
Height
Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Anthropometry (3)
Body mass index
Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Anthropometry (4)
Waist circumference
Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Anthropometry (5)
Hip circumference
Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Anthropometry (6)
Waist-to-hip ratio
Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Quality of life score
32-item questionnaire (including social, spiritual, emotional, cognitive, physical, activities of daily living, and integrated Quality of Life)
Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Fatigue
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
Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Physical activity
Baecke's questionnaire
Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Mood
Affect grid
Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
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
Time frame: T=0 months, T=6 months, T=12 months
Immune cell characterisation
Fluorescence-activated cell sorting (FACS)
Time frame: T=0 months, T=6 months, T=12 months
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