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NCT Number: NCT03983603

Plant Stanol Esters and Preventing Asthma Symptoms

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.

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Key information

Conditions

Asthma, Allergic Asthma Bronchial Diseases Cardiovascular Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, Limburg, 6229ER, Netherlands

Location status: Recruiting

Location contact

Jogchum Plat, PhD

PRINCIPAL_INVESTIGATOR

Lieve van Brakel, MSc

CONTACT

[email protected]

+31433882113

Ronald P Mensink, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Asthma control questionnaire score

    Time frame: Change between T=0 months and T=12 months

    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.

Secondary outcomes

  1. Asthma control questionnaire score

    Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

    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.

  2. Forced expiratory volume in 1 second

    Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

    Amount of air that can be exhaled forcefully in one second in Liters or %

  3. Forced vital capacity

    Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

    Amount of air that can be exhaled forcefully in total in Liters or %

  4. Asthma related medication use

    Time frame: Throughout 1 year

    Self-reported medication use

  5. Number of visits to the general practitioner or hospital

    Time frame: Throughout 1 year

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

  6. Incidence counts of exacerbations and other asthma related complaints

    Time frame: Throughout 1 year

    Self-reported amount of exacerbations and other asthma related complaints

  7. Duration of exacerbations

    Time frame: Throughout 1 year

    Self-reported duration of exacerbations

  8. Severity of exacerbations

    Time frame: Throughout 1 year

    Self-reported severity of exacerbations

  9. Calculated disease load

    Time frame: Throughout 1 year

    Number x duration of exacerbations

  10. Number of infections that occur throughout the study

    Time frame: Throughout 1 year

    Self-reported amount of infections

  11. Leukocyte count

    Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

    Number of leukocytes measured in EDTA plasma

  12. Leukocyte differential count

    Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

    Number of subgroups of leukocytes measured in EDTA plasma

  13. Red blood cell count

    Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

    Number of red blood cells measured in EDTA plasma

  14. Platelet count

    Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

    Number of platelets measured in EDTA plasma

  15. Hematocrit

    Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

    Hematocrit measured in EDTA plasma

  16. Hemoglobin

    Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

    Hemoglobin measured in EDTA plasma

  17. Immune parameters (1)

    Time frame: T=0 months, T=6 months, T=12 months

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

  18. Immune parameters (2)

    Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

    Total IgE

  19. Immune parameters (3)

    Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

    Total IgM

  20. Immune parameters (4)

    Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

    hsCRP

  21. Fasted metabolism (1)

    Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

    Serum lipid and lipoprotein profile

  22. Fasted metabolism (2)

    Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

    Serum non-cholesterol sterols and stanols

  23. Fasted metabolism (3)

    Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

    Plasma glucose metabolism

  24. Vascular function markers (1)

    Time frame: T=0 months and T=12 months

    Carotid-femoral pulse wave velocity (PWV)

  25. Vascular function markers (2)

    Time frame: T=0 months and T=12 months

    Pulse wave analysis (PWA)

  26. Vascular function markers (3)

    Time frame: T=0 months and T=12 months

    Retinal microvascular caliber

  27. Cardiometabolic risk marker

    Time frame: T=0 months and T=12 months

    Office blood pressure

  28. Cognitive function

    Time frame: T=0 months and T=12 months

    CANTAB tests

  29. Anthropometry (1)

    Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

    Body weight

  30. Anthropometry (2)

    Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

    Height

  31. Anthropometry (3)

    Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

    Body mass index

  32. Anthropometry (4)

    Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

    Waist circumference

  33. Anthropometry (5)

    Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

    Hip circumference

  34. Anthropometry (6)

    Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

    Waist-to-hip ratio

  35. Quality of life score

    Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

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

  36. Fatigue

    Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

    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

  37. Physical activity

    Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

    Baecke's questionnaire

  38. Mood

    Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months

    Affect grid

  39. Diet

    Time frame: T=0 months, T=6 months, T=12 months

    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

  40. Immune cell characterisation

    Time frame: T=0 months, T=6 months, T=12 months

    Fluorescence-activated cell sorting (FACS)

Other outcomes

  1. Mechanistic outcomes for measuring the immune response

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

    Vaccination response to vaccines against tetanus, pneumococcal bacteria and rabies

Study contacts

Contact information is provided by the study sponsor or research team.

Jogchum Plat, PhD

CONTACT

[email protected]

+31433881309

Lieve van Brakel, MSc

CONTACT

[email protected]

+31433882113

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Raisio Group
  • TKI Life Sciences and Health (LSH)

Registry information

Official study 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

Acronym: PLANTASTIC

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2019
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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