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Plant Stanol Esters and Preventing Asthma Symptoms

NCT03983603 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2024-05-22

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Raisio Group

    collaborator INDUSTRY

  • TKI Life Sciences and Health (LSH)

    collaborator UNKNOWN

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Jogchum Plat, PhD · Maastricht University Medical Center

  • Ronald P Mensink, PhD · Maastricht University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-29
Primary Completion
2024-09-30
Completion
2024-09-30

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03983603 on ClinicalTrials.gov