Plant Stanol Esters and Preventing Asthma Symptoms
PLANTASTIC
Plant Stanol Esters in the Prevention of Clinical Symptoms Related to Asthma: The PLANTASTIC Trial
1 other identifier
interventional
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 29, 2019
CompletedFirst Submitted
Initial submission to the registry
June 4, 2019
CompletedFirst Posted
Study publicly available on registry
June 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedMay 22, 2024
February 1, 2024
5.3 years
June 4, 2019
May 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Change between T=0 months and T=12 months
Secondary Outcomes (40)
Asthma control questionnaire score
T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Forced expiratory volume in 1 second
T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Forced vital capacity
T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Asthma related medication use
Throughout 1 year
Number of visits to the general practitioner or hospital
Throughout 1 year
- +35 more secondary outcomes
Other Outcomes (1)
Mechanistic outcomes for measuring the immune response
Weekly from T=12 months to T=13 months
Study Arms (2)
Plant stanol group
EXPERIMENTALThis arm receives soft chews containing 0.5g of plant stanols (delivered as plant stanol esters).
Placebo group
PLACEBO COMPARATORThis arm receives soft chews that do not contain 0.5g of plant stanols (delivered as plant stanol esters).
Interventions
Soft chews containing 0.5g plant stanols delivered as plant stanol esters
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maastricht University Medical Centerlead
- Raisio Groupcollaborator
- TKI Life Sciences and Health (LSH)collaborator
Study Sites (1)
Maastricht University Medical Center
Maastricht, Limburg, 6229ER, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jogchum Plat, PhD
Maastricht University Medical Center
- PRINCIPAL INVESTIGATOR
Ronald P Mensink, PhD
Maastricht University Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2019
First Posted
June 12, 2019
Study Start
April 29, 2019
Primary Completion
September 1, 2024
Study Completion
September 1, 2024
Last Updated
May 22, 2024
Record last verified: 2024-02