NCT03983603 Plant Stanol Esters and Preventing Asthma Symptoms
| NCT ID | NCT03983603 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maastricht University Medical Center |
| Condition | Asthma, Allergic |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2019-04-29 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2019-04-29 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Jogchum Plat, PhD
PRINCIPAL INVESTIGATOR
Maastricht University Medical Center
Frequently Asked Questions
Who can join the NCT03983603 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Asthma, Allergic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03983603 currently recruiting?
Yes, NCT03983603 is actively recruiting participants. Contact the research team at j.plat@maastrichtuniversity.nl for enrollment information.
Where is the NCT03983603 trial being conducted?
This trial is being conducted at Maastricht, Netherlands.
Who is sponsoring the NCT03983603 clinical trial?
NCT03983603 is sponsored by Maastricht University Medical Center. The principal investigator is Jogchum Plat, PhD at Maastricht University Medical Center. The trial plans to enroll 160 participants.
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