Plant Stanol Esters and Preventing Asthma Symptoms

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMaastricht University Medical Center

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Soft chews containing 0.5g plant stanols (delivered as plant stanol esters)
  • Placebo soft chew

Treatment groups

160 Participants
are divided into 2 treatment groups

Locations

1
Maastricht University Medical Center6229ER, MaastrichtLimburg, Netherlands

Sponsors and collaborators

Maastricht University Medical Center

Lead sponsor

Raisio Group

Collaborator

TKI Life Sciences and Health (LSH)

Collaborator