Clinical trial NCT03983603: Plant Stanol Esters and Preventing Asthma Symptoms
Official title: Plant Stanol Esters in the Prevention of Clinical Symptoms Related to Asthma: The PLANTASTIC Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma, Allergic
Cardiovascular Diseases
Keywords: Plant stanols
Asthma
Immune system
Metabolic health
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Raisio Group
name: TKI Life Sciences and Health (LSH)
First posted: 2019-06-12
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Asthma control questionnaire score
timeFrame: Change between T=0 months and T=12 months
Secondary outcomes:
measure: Asthma control questionnaire score
timeFrame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
measure: Forced expiratory volume in 1 second
timeFrame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
measure: Forced vital capacity
timeFrame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
measure: Asthma related medication use
timeFrame: Throughout 1 year
measure: Number of visits to the general practitioner or hospital
timeFrame: Throughout 1 year
measure: Incidence counts of exacerbations and other asthma related complaints
timeFrame: Throughout 1 year
measure: Duration of exacerbations
timeFrame: Throughout 1 year
measure: Severity of exacerbations
timeFrame: Throughout 1 year
measure: Calculated disease load
timeFrame: Throughout 1 year
measure: Number of infections that occur throughout the study
timeFrame: Throughout 1 year
measure: Leukocyte count
timeFrame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
measure: Leukocyte differential count
timeFrame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
measure: Red blood cell count
timeFrame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
measure: Platelet count
timeFrame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
measure: Hematocrit
timeFrame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
measure: Hemoglobin
timeFrame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
measure: Immune parameters (1)
timeFrame: T=0 months, T=6 months, T=12 months
measure: Immune parameters (2)
timeFrame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
measure: Immune parameters (3)
timeFrame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
measure: Immune parameters (4)
timeFrame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
measure: Fasted metabolism (1)
timeFrame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
measure: Fasted metabolism (2)
timeFrame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
measure: Fasted metabolism (3)
timeFrame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
measure: Vascular function markers (1)
timeFrame: T=0 months and T=12 months
measure: Vascular function markers (2)
timeFrame: T=0 months and T=12 months
measure: Vascular function markers (3)
timeFrame: T=0 months and T=12 months
measure: Cardiometabolic risk marker
timeFrame: T=0 months and T=12 months
measure: Cognitive function
timeFrame: T=0 months and T=12 months
measure: Anthropometry (1)
timeFrame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
measure: Anthropometry (2)
timeFrame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
measure: Anthropometry (3)
timeFrame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
measure: Anthropometry (4)
timeFrame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
measure: Anthropometry (5)
timeFrame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
measure: Anthropometry (6)
timeFrame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
measure: Quality of life score
timeFrame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
measure: Fatigue
timeFrame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
measure: Physical activity
timeFrame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
measure: Mood
timeFrame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
measure: Diet
timeFrame: T=0 months, T=6 months, T=12 months
measure: Immune cell characterisation
timeFrame: T=0 months, T=6 months, T=12 months
Other outcomes:
measure: Mechanistic outcomes for measuring the immune response
timeFrame: Weekly from T=12 months to T=13 months
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Jogchum Plat, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Center
name: Ronald P Mensink, PhD
role: PRINCIPAL_INVESTIGATOR
References: