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Probiotics for Vascular Inflammation in Metabolic Syndrome

NCT03719794 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-01-14

No results posted yet for this study

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

DIETARY_SUPPLEMENT

Probiotic supplement

Probiotic supplement once daily (xyz) for 12 weeks

DIETARY_SUPPLEMENT

Placebo supplement

Placebo supplement once daily for 12 weeks

Sponsors & Collaborators

  • Lallemand Health Solutions

    collaborator INDUSTRY

  • Montreal Heart Institute

    lead OTHER

Principal Investigators

  • Anil Nigam, MD · Montreal Heart Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-16
Primary Completion
2020-10-01
Completion
2020-10-01

Countries

  • Canada

Study Locations

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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 NCT03719794 on ClinicalTrials.gov