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Tests plant stanol chews for allergic asthma symptoms

Tests daily plant stanol chews against placebo in adults with allergic asthma.

Plain-language title generated from the registry record
Registry title: Plant Stanol Esters and Preventing Asthma Symptoms

Key facts

Where
Maastricht, NetherlandsSee the site

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18-70 with stable allergic asthma, to test whether daily plant stanol ester soft chews reduce asthma symptoms.

Age
18 to 70 years
Sex
All sexes
Disease stage
Allergic asthma, GINA step 1-4, stable for at least the past three months (no change in asthma control and lung function).
Earlier treatment
Treated with prescribed asthma medication for at least one year. Must stop products with plant sterols or stanols one month before the study and during it.
Biomarker or test result
BMI between 20 and 35 kg/m2.

Main reasons for not taking part

  • Smoking now, or quit smoking in the past year, or more than 10 packyears of smoking history
  • Allergy to an ingredient of the soft chews
  • Inflammatory diseases (for cardiovascular disease, only if it was less than 3 years ago or is not under control)
  • Fasting plasma glucose above 7.0 mmol/L (126 mg/dL) or fasting serum TC above 8.0 mmol/L (144 mg/dL)
  • Pregnant or breastfeeding women

Read by machine on 9 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 70 years old?

Source: NCT03983603, who can take part

Where in Netherlands

  • Maastricht University Medical CenterMaastricht, NetherlandsTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Maastricht University Medical Center
Trial code
NCT03983603
Record updated
25 June 2026
Original description
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.Read full original descriptionShow less

The Effects of Long-term Daily Plant Stanol Ester Intake on Clinical Symptoms in Individuals With Allergic Asthma: an Exploratory Double-blind Randomized Controlled 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.

Inclusion: 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: Having donated blood within one month prior to the start of the study, or planning to donate blood during the study; 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; 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); Pregnant women; Breastfeeding women.

ClinicalTrials.gov NCT03983603