Plant Stanol Esters and Preventing Asthma Symptoms (PLANTASTIC)

Maastricht University Medical Centre (MUMC)

Status: Enrolling

Conditions: Asthma, Allergic; Cardiovascular Diseases

Treatments: Dietary Supplement: Soft chews containing 0.5g plant stanols (delivered as plant stanol esters); Dietary Supplement: Placebo soft chew

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03983603

METC 18-064

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 2 patient groups, including a placebo group

Plant stanol group

Experimental group

Description:

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

Treatment:

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

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo soft chew