NCT03983603

Plant Stanol Esters and Preventing Asthma Symptoms

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

• Asthma, Allergic
• Cardiovascular Diseases

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-04-29
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2019-06-12
• Last updated: 2024-05-22

Locations

1 site across 1 country: Netherlands