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Plant Stanol Esters and Preventing Asthma Symptoms (PLANTASTIC)

Primary Purpose

Asthma, Allergic, Cardiovascular Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Soft chews containing 0.5g plant stanols (delivered as plant stanol esters)
Placebo soft chew
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma, Allergic focused on measuring Plant stanols, Asthma, Immune system, Metabolic health

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maastricht University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Plant stanol group

Placebo group

Arm Description

This arm receives soft chews containing 0.5g of plant stanols (delivered as plant stanol esters).

This arm receives soft chews that do not contain 0.5g of plant stanols (delivered as plant stanol esters).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Forced expiratory volume in 1 second
Amount of air that can be exhaled forcefully in one second in Liters or %
Forced vital capacity
Amount of air that can be exhaled forcefully in total in Liters or %
Asthma related medication use
Self-reported medication use
Number of visits to the general practitioner or hospital
Self-reported amount of visits to the general practitioner or hospital
Incidence counts of exacerbations and other asthma related complaints
Self-reported amount of exacerbations and other asthma related complaints
Duration of exacerbations
Self-reported duration of exacerbations
Severity of exacerbations
Self-reported severity of exacerbations
Calculated disease load
Number x duration of exacerbations
Number of infections that occur throughout the study
Self-reported amount of infections
Leukocyte count
Number of leukocytes measured in EDTA plasma
Leukocyte differential count
Number of subgroups of leukocytes measured in EDTA plasma
Red blood cell count
Number of red blood cells measured in EDTA plasma
Platelet count
Number of platelets measured in EDTA plasma
Hematocrit
Hematocrit measured in EDTA plasma
Hemoglobin
Hemoglobin measured in EDTA plasma
Immune parameters (1)
Cytokine production by PBMCs after stimulation with antiCD3-antiCD28 antiCD28 antibodies using the TruCulture system
Immune parameters (2)
Total IgE
Immune parameters (3)
Total IgM
Immune parameters (4)
hsCRP
Fasted metabolism (1)
Serum lipid and lipoprotein profile
Fasted metabolism (2)
Serum non-cholesterol sterols and stanols
Fasted metabolism (3)
Plasma glucose metabolism
Vascular function markers (1)
Carotid-femoral pulse wave velocity (PWV)
Vascular function markers (2)
Pulse wave analysis (PWA)
Vascular function markers (3)
Retinal microvascular caliber
Cardiometabolic risk marker
Office blood pressure
Cognitive function
CANTAB tests
Anthropometry (1)
Body weight
Anthropometry (2)
Height
Anthropometry (3)
Body mass index
Anthropometry (4)
Waist circumference
Anthropometry (5)
Hip circumference
Anthropometry (6)
Waist-to-hip ratio
Quality of life score
32-item questionnaire (including social, spiritual, emotional, cognitive, physical, activities of daily living, and integrated Quality of Life)
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
Physical activity
Baecke's questionnaire
Mood
Affect grid
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
Immune cell characterisation
Fluorescence-activated cell sorting (FACS)

Full Information

First Posted
June 4, 2019
Last Updated
February 7, 2023
Sponsor
Maastricht University Medical Center
Collaborators
Raisio Group, TKI Life Sciences and Health (LSH)
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1. Study Identification

Unique Protocol Identification Number
NCT03983603
Brief Title
Plant Stanol Esters and Preventing Asthma Symptoms
Acronym
PLANTASTIC
Official Title
Plant Stanol Esters in the Prevention of Clinical Symptoms Related to Asthma: The PLANTASTIC Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 29, 2019 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Raisio Group, TKI Life Sciences and Health (LSH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Allergic, Cardiovascular Diseases
Keywords
Plant stanols, Asthma, Immune system, Metabolic health

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Plant stanol group
Arm Type
Experimental
Arm Description
This arm receives soft chews containing 0.5g of plant stanols (delivered as plant stanol esters).
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
This arm receives soft chews that do not contain 0.5g of plant stanols (delivered as plant stanol esters).
Intervention Type
Dietary Supplement
Intervention Name(s)
Soft chews containing 0.5g plant stanols (delivered as plant stanol esters)
Intervention Description
Soft chews containing 0.5g plant stanols delivered as plant stanol esters
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo soft chew
Intervention Description
Soft chew that does not contain plant stanols
Primary Outcome Measure Information:
Title
Asthma control questionnaire score
Description
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.
Time Frame
Change between T=0 months and T=12 months
Secondary Outcome Measure Information:
Title
Asthma control questionnaire score
Description
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.
Time Frame
T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Title
Forced expiratory volume in 1 second
Description
Amount of air that can be exhaled forcefully in one second in Liters or %
Time Frame
T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Title
Forced vital capacity
Description
Amount of air that can be exhaled forcefully in total in Liters or %
Time Frame
T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Title
Asthma related medication use
Description
Self-reported medication use
Time Frame
Throughout 1 year
Title
Number of visits to the general practitioner or hospital
Description
Self-reported amount of visits to the general practitioner or hospital
Time Frame
Throughout 1 year
Title
Incidence counts of exacerbations and other asthma related complaints
Description
Self-reported amount of exacerbations and other asthma related complaints
Time Frame
Throughout 1 year
Title
Duration of exacerbations
Description
Self-reported duration of exacerbations
Time Frame
Throughout 1 year
Title
Severity of exacerbations
Description
Self-reported severity of exacerbations
Time Frame
Throughout 1 year
Title
Calculated disease load
Description
Number x duration of exacerbations
Time Frame
Throughout 1 year
Title
Number of infections that occur throughout the study
Description
Self-reported amount of infections
Time Frame
Throughout 1 year
Title
Leukocyte count
Description
Number of leukocytes measured in EDTA plasma
Time Frame
T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Title
Leukocyte differential count
Description
Number of subgroups of leukocytes measured in EDTA plasma
Time Frame
T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Title
Red blood cell count
Description
Number of red blood cells measured in EDTA plasma
Time Frame
T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Title
Platelet count
Description
Number of platelets measured in EDTA plasma
Time Frame
T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Title
Hematocrit
Description
Hematocrit measured in EDTA plasma
Time Frame
T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Title
Hemoglobin
Description
Hemoglobin measured in EDTA plasma
Time Frame
T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Title
Immune parameters (1)
Description
Cytokine production by PBMCs after stimulation with antiCD3-antiCD28 antiCD28 antibodies using the TruCulture system
Time Frame
T=0 months, T=6 months, T=12 months
Title
Immune parameters (2)
Description
Total IgE
Time Frame
T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Title
Immune parameters (3)
Description
Total IgM
Time Frame
T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Title
Immune parameters (4)
Description
hsCRP
Time Frame
T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Title
Fasted metabolism (1)
Description
Serum lipid and lipoprotein profile
Time Frame
T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Title
Fasted metabolism (2)
Description
Serum non-cholesterol sterols and stanols
Time Frame
T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Title
Fasted metabolism (3)
Description
Plasma glucose metabolism
Time Frame
T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Title
Vascular function markers (1)
Description
Carotid-femoral pulse wave velocity (PWV)
Time Frame
T=0 months and T=12 months
Title
Vascular function markers (2)
Description
Pulse wave analysis (PWA)
Time Frame
T=0 months and T=12 months
Title
Vascular function markers (3)
Description
Retinal microvascular caliber
Time Frame
T=0 months and T=12 months
Title
Cardiometabolic risk marker
Description
Office blood pressure
Time Frame
T=0 months and T=12 months
Title
Cognitive function
Description
CANTAB tests
Time Frame
T=0 months and T=12 months
Title
Anthropometry (1)
Description
Body weight
Time Frame
T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Title
Anthropometry (2)
Description
Height
Time Frame
T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Title
Anthropometry (3)
Description
Body mass index
Time Frame
T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Title
Anthropometry (4)
Description
Waist circumference
Time Frame
T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Title
Anthropometry (5)
Description
Hip circumference
Time Frame
T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Title
Anthropometry (6)
Description
Waist-to-hip ratio
Time Frame
T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Title
Quality of life score
Description
32-item questionnaire (including social, spiritual, emotional, cognitive, physical, activities of daily living, and integrated Quality of Life)
Time Frame
T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Title
Fatigue
Description
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
Time Frame
T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Title
Physical activity
Description
Baecke's questionnaire
Time Frame
T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Title
Mood
Description
Affect grid
Time Frame
T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Title
Diet
Description
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
Time Frame
T=0 months, T=6 months, T=12 months
Title
Immune cell characterisation
Description
Fluorescence-activated cell sorting (FACS)
Time Frame
T=0 months, T=6 months, T=12 months
Other Pre-specified Outcome Measures:
Title
Mechanistic outcomes for measuring the immune response
Description
Vaccination response to vaccines against tetanus, pneumococcal bacteria and rabies
Time Frame
Weekly from T=12 months to T=13 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jogchum Plat, PhD
Phone
+31433881309
Email
j.plat@maastrichtuniversity.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Lieve van Brakel, MSc
Phone
+31433882113
Email
lieve.vanbrakel@maastrichtuniversity.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jogchum Plat, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ronald P Mensink, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229ER
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lieve van Brakel, MSc
Phone
+31433882113
Email
lieve.vanbrakel@maastrichtuniversity.nl
First Name & Middle Initial & Last Name & Degree
Jogchum Plat, PhD
First Name & Middle Initial & Last Name & Degree
Ronald P Mensink, PhD

12. IPD Sharing Statement

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Plant Stanol Esters and Preventing Asthma Symptoms

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