NCT03719794

Probiotics for Vascular Inflammation in Metabolic Syndrome

Probiotics for Vascular Inflammation in Metabolic Syndrome (PROMISE): a 12-Week Pilot Study, Randomized,Double-Blinded, Placebo-Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Montreal Heart Institute · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

Subjects with metabolic syndrome are known to possess chronic low-level inflammation. Furthermore, such individuals are at risk of developing atherosclerosis in coronary and other vascular beds. In particular, subjects with metabolic syndrome, prediabetes and type II diabetes mellitus were shown to possess vascular inflammation in carotid atherosclerosis as demonstrated using FDG-PET. In the current pilot proposal, the investigators wish to study the impact of 3-month probiotic supplementation on vascular and systemic inflammation in subjects with metabolic syndrome in the context of a randomized, placebo-controlled, pilot trial.

Conditions

• Metabolic Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic supplement	Probiotic supplement once daily (xyz) for 12 weeks
DIETARY_SUPPLEMENT	Placebo supplement	Placebo supplement once daily for 12 weeks

Timeline

• Start date: 2018-04-16
• Primary completion: 2020-10-01
• Completion: 2020-10-01
• First posted: 2018-10-25
• Last updated: 2021-01-14

Locations

1 site across 1 country: Canada