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Recruiting NCT03983603

Plant Stanol Esters and Preventing Asthma Symptoms

No phase Interventional Asthma, Allergic Cardiovascular Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Soft chews containing 0.5g plant stanols (delivered as plant stanol esters), Placebo soft chew.
Who it may be relevant to
Registry conditions: Asthma, Allergic, Cardiovascular Diseases. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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
  • Dietary supplement Placebo soft chew
    Soft chew that does not contain plant stanols

Primary outcome measures

  • Asthma control questionnaire score [Time frame: Change between T=0 months and T=12 months]
Secondary outcome measures (12)
  • Asthma control questionnaire score [Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months]
  • Forced expiratory volume in 1 second [Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months]
  • Forced vital capacity [Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months]
  • Asthma related medication use [Time frame: Throughout 1 year]
  • Number of visits to the general practitioner or hospital [Time frame: Throughout 1 year]
  • Incidence counts of exacerbations and other asthma related complaints [Time frame: Throughout 1 year]
  • Duration of exacerbations [Time frame: Throughout 1 year]
  • Severity of exacerbations [Time frame: Throughout 1 year]
  • Calculated disease load [Time frame: Throughout 1 year]
  • Number of infections that occur throughout the study [Time frame: Throughout 1 year]
  • Leukocyte count [Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months]
  • Leukocyte differential count [Time frame: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

Netherlands · 1 center
  • Maastricht University Medical Center — Maastricht

Identifiers

NCT: NCT03983603 · METC 18-064

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗