Trial | NCT03983603  Report issue

Title

Plant Stanol Esters and Preventing Asthma Symptoms
Plant Stanol Esters in the Prevention of Clinical Symptoms Related to Asthma: The PLANTASTIC Trial

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    160
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.
Study Started
Apr 29
2019
Primary Completion
Sep 30
2024
Anticipated
Study Completion
Sep 30
2024
Anticipated
Last Update
Feb 08
2023

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

Plant stanol group Experimental

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

Placebo group Placebo Comparator

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

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
No Results Posted