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Asthma, AllergicPLANTASTICNCT03983603

Plant Stanol Esters and Preventing Asthma Symptoms

A study testing Soft chews containing 0.5g plant stanols (delivered as plant stanol esters) in people with Asthma, Allergic and Cardiovascular Diseases, run by Maastricht University Medical Center at 1 site in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Asthma, Allergic, Cardiovascular Diseases
What is being tested?
Soft chews containing 0.5g plant stanols (delivered as plant stanol esters)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
1 siteNetherlands
Study dates
29 Apr 2019to Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jogchum Plat, PhD contact

+31433881309

j.plat@maastrichtuniversity.nl

Lieve van Brakel, MSc contact

+31433882113

lieve.vanbrakel@maastrichtuniversity.nl

Netherlands1 site, 1 recruiting

  • Maastricht University Medical Center

    Maastricht, Limburg, 6229ER

    Lieve van Brakel, MSc, +31433882113, lieve.vanbrakel@maastrichtuniversity.nl

    Jogchum Plat, PhD

    Recruiting

Other trials in Netherlands

About this study

Official title: 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.

Being tested
Soft chews containing 0.5g plant stanols (delivered as plant stanol esters), Placebo soft chew
Keywords
Plant stanols, Asthma, Immune system, Metabolic health
Medical subject headings
Asthma, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 chewDietary supplement

    Soft chew that does not contain plant stanols

Study groups in NCT03983603
Study groupRoleWhat they receive
Plant stanol groupExperimentalThis arm receives soft chews containing 0.5g of plant stanols (delivered as plant stanol esters).
Receives: Dietary Supplement: Soft chews containing 0.5g plant stanols (delivered as plant stanol esters)
Placebo groupPlacebo comparatorThis arm receives soft chews that do not contain 0.5g of plant stanols (delivered as plant stanol esters).
Receives: Dietary Supplement: Placebo soft chew

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Change between T=0 months and T=12 months

Secondary outcomes (40)

  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.

    Measured: 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 %

    Measured: 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 %

    Measured: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

  4. Asthma related medication use

    Self-reported medication use

    Measured: Throughout 1 year

  5. Number of visits to the general practitioner or hospital

    Self-reported amount of visits to the general practitioner or hospital

    Measured: Throughout 1 year

  6. Incidence counts of exacerbations and other asthma related complaints

    Self-reported amount of exacerbations and other asthma related complaints

    Measured: Throughout 1 year

  7. Duration of exacerbations

    Self-reported duration of exacerbations

    Measured: Throughout 1 year

  8. Severity of exacerbations

    Self-reported severity of exacerbations

    Measured: Throughout 1 year

  9. Calculated disease load

    Number x duration of exacerbations

    Measured: Throughout 1 year

  10. Number of infections that occur throughout the study

    Self-reported amount of infections

    Measured: Throughout 1 year

  11. Leukocyte count

    Number of leukocytes measured in EDTA plasma

    Measured: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

  12. Leukocyte differential count

    Number of subgroups of leukocytes measured in EDTA plasma

    Measured: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

  13. Red blood cell count

    Number of red blood cells measured in EDTA plasma

    Measured: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

  14. Platelet count

    Number of platelets measured in EDTA plasma

    Measured: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

  15. Hematocrit

    Hematocrit measured in EDTA plasma

    Measured: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

  16. Hemoglobin

    Hemoglobin measured in EDTA plasma

    Measured: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

  17. Immune parameters (1)

    Cytokine production by PBMCs after stimulation with antiCD3-antiCD28 antiCD28 antibodies using the TruCulture system

    Measured: T=0 months, T=6 months, T=12 months

  18. Immune parameters (2)

    Total IgE

    Measured: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

  19. Immune parameters (3)

    Total IgM

    Measured: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

  20. Immune parameters (4)

    hsCRP

    Measured: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

  21. Fasted metabolism (1)

    Serum lipid and lipoprotein profile

    Measured: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

  22. Fasted metabolism (2)

    Serum non-cholesterol sterols and stanols

    Measured: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

  23. Fasted metabolism (3)

    Plasma glucose metabolism

    Measured: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

  24. Vascular function markers (1)

    Carotid-femoral pulse wave velocity (PWV)

    Measured: T=0 months and T=12 months

  25. Vascular function markers (2)

    Pulse wave analysis (PWA)

    Measured: T=0 months and T=12 months

  26. Vascular function markers (3)

    Retinal microvascular caliber

    Measured: T=0 months and T=12 months

  27. Cardiometabolic risk marker

    Office blood pressure

    Measured: T=0 months and T=12 months

  28. Cognitive function

    CANTAB tests

    Measured: T=0 months and T=12 months

  29. Anthropometry (1)

    Body weight

    Measured: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

  30. Anthropometry (2)

    Height

    Measured: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

  31. Anthropometry (3)

    Body mass index

    Measured: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

  32. Anthropometry (4)

    Waist circumference

    Measured: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

  33. Anthropometry (5)

    Hip circumference

    Measured: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

  34. Anthropometry (6)

    Waist-to-hip ratio

    Measured: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

  35. Quality of life score

    32-item questionnaire (including social, spiritual, emotional, cognitive, physical, activities of daily living, and integrated Quality of Life)

    Measured: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

  36. Fatigue

    Fatigue severity score (FSS), a 9-item questionnaire is used to determine the severity of fatigue a subject experienced in the past week during daily activities

    Measured: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

  37. Physical activity

    Baecke's questionnaire

    Measured: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

  38. Mood

    Affect grid

    Measured: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

  39. Diet

    Food frequency questionnaire is used to determine if the participants maintain their habitual diet and to determine if the participants do not consume plant stanols and/or sterols outside the intervention

    Measured: T=0 months, T=6 months, T=12 months

  40. Immune cell characterisation

    Fluorescence-activated cell sorting (FACS)

    Measured: T=0 months, T=6 months, T=12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2019
  2. Study start29 Apr 2019
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03983603
Sponsor's protocol ID
METC 18-064
Acronym
PLANTASTIC
Status last verified
Jun 2026
First submitted
4 Jun 2019
Last updated
25 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Soft chews containing 0.5g plant stanols (delivered as plant stanol esters) in people with Asthma, Allergic and Cardiovascular Diseases, run by Maastricht University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jogchum Plat, PhD (+31433881309, j.plat@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Asthma control questionnaire score (time frame: Change between T=0 months and T=12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03983603.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.

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