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NCT03983603 | RECRUITING | Asthma, Allergic

Plant Stanol Esters and Preventing Asthma Symptoms
Sponsor:

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

Asthma, Allergic

Cardiovascular Diseases

Intervention/treatment

Soft chews containing 0.5g plant stanols (delivered as plant stanol esters)

Placebo soft chew

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 160 participants
Masking : TRIPLE
Primary Purpose : PREVENTION
Official Title : Plant Stanol Esters in the Prevention of Clinical Symptoms Related to Asthma: The PLANTASTIC Trial
Actual Study Start Date : 2019-04-29
Estimated Primary Completion Date : 2024-09
Estimated Study Completion Date : 2024-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Plant Stanol Esters and Preventing Asthma Symptoms

Location Details

NCT03983603

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Netherlands, Limburg

Maastricht University Medical Center

Maastricht, Limburg, Netherlands, 6229ER