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Plant Stanol Esters and Preventing Asthma Symptoms (PLANTASTIC)

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ClinicalTrials.gov Identifier: NCT03983603
Recruitment Status : Recruiting
First Posted : June 12, 2019
Last Update Posted : June 12, 2019
Sponsor:
Collaborators:
Raisio Group
TKI Life Sciences and Health (LSH)
Information provided by (Responsible Party):
Maastricht University Medical Center

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.

Condition or disease Intervention/treatment Phase
Asthma, Allergic Cardiovascular Diseases Dietary Supplement: Soft chews containing 0.5g plant stanols (delivered as plant stanol esters) Dietary Supplement: Placebo soft chew Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Plant Stanol Esters in the Prevention of Clinical Symptoms Related to Asthma: The PLANTASTIC Trial
Actual Study Start Date : April 29, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Plant stanol group
This arm receives soft chews containing 0.5g of plant stanols (delivered as plant stanol esters).
Dietary Supplement: Soft chews containing 0.5g plant stanols (delivered as plant stanol esters)
Soft chews containing 0.5g plant stanols delivered as plant stanol esters

Placebo Comparator: Placebo group
This arm receives soft chews that do not contain 0.5g of plant stanols (delivered as plant stanol esters).
Dietary Supplement: Placebo soft chew
Soft chew that does not contain plant stanols




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with allergic asthma (GINA step 2) 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 low dose ICS 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
  • (History of) using immunosuppressive medication other than ICS (e.g. use of oral steroids or Prednisone in the year prior to starting the study)
  • Suffering from inflammatory diseases
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03983603


Contacts
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Contact: Jogchum Plat, PhD +31433881309 j.plat@maastrichtuniversity.nl
Contact: Lieve van Brakel, MSc +31433882113 lieve.vanbrakel@maastrichtuniversity.nl

Locations
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Netherlands
Maastricht University Medical Center Recruiting
Maastricht, Limburg, Netherlands, 6229ER
Contact: Lieve van Brakel, MSc    +31433882113    lieve.vanbrakel@maastrichtuniversity.nl   
Principal Investigator: Jogchum Plat, PhD         
Principal Investigator: Ronald P Mensink, PhD         
Sponsors and Collaborators
Maastricht University Medical Center
Raisio Group
TKI Life Sciences and Health (LSH)
Investigators
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Principal Investigator: Jogchum Plat, PhD Maastricht University Medical Center
Principal Investigator: Ronald P Mensink, PhD Maastricht University Medical Center

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT03983603     History of Changes
Other Study ID Numbers: METC 18-064
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maastricht University Medical Center:
Plant stanols
Asthma
Immune system
Metabolic health
Additional relevant MeSH terms:
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Asthma
Cardiovascular Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases