Health TrialsbyHealthPanel

Plant Stanol Esters and Preventing Asthma Symptoms

ConditionsAsthma, AllergicCardiovascular Diseases
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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

    Dietary supplement

    Soft chews containing 0.5g plant stanols delivered as plant stanol esters

  • Placebo soft chew

    Dietary supplement

    Soft chew that does not contain plant stanols

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Plant stanol groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
Change between T=0 months and T=12 months

Secondary outcomes

1

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
2

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
3

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
4

Asthma related medication use

Self-reported medication use

Time frame
Throughout 1 year

Other outcomes

1

Mechanistic outcomes for measuring the immune response

Vaccination response to vaccines against tetanus, pneumococcal bacteria and rabies

Time frame
Weekly from T=12 months to T=13 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Maastricht University Medical Center

Lead sponsor

Raisio Group

Collaborator

TKI Life Sciences and Health (LSH)

Collaborator

Source ClinicalTrials.gov
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