Plant Stanol Esters and Preventing Asthma Symptoms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-29

Study Completion Date

2024-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma, Allergic Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Plant stanol group

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

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

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

Placebo group

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

Group Type PLACEBO_COMPARATOR

Placebo soft chew

Intervention Type DIETARY_SUPPLEMENT

Soft chew that does not contain plant stanols

Interventions

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

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

Intervention Type DIETARY_SUPPLEMENT

Placebo soft chew

Soft chew that does not contain plant stanols

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No