Probiotics for Vascular Inflammation in Metabolic Syndrome

NCT ID: NCT03719794

Last Updated: 2021-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-16
• Study Completion Date: 2020-10-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Probiotics arm

The active comparator arm will be of a 12-week probiotic supplement regimen (one capsule daily, containing 20 x 109 CFU of Bifidobacterium animalis ssp. Lactis Lafti®B94 and Lactobacillus plantarum R1012)

Group Type: ACTIVE_COMPARATOR

Probiotic supplement

Intervention Type: DIETARY_SUPPLEMENT

Probiotic supplement once daily (xyz) for 12 weeks

Placebo arm

The placebo comparator arm will be of a 12-week placebo supplement regimen.

Group Type: PLACEBO_COMPARATOR

Placebo supplement

Intervention Type: DIETARY_SUPPLEMENT

Placebo supplement once daily for 12 weeks

Interventions

Probiotic supplement

Probiotic supplement once daily (xyz) for 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

Placebo supplement

Placebo supplement once daily for 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Male and female age > 50 years
• Presence of MetS as defined according to recent updated criteria (13): Presence of at least three of five criteria, namely abdominal obesity (waist circumference cut-off) depending on the recently published ethnic-based variations (14), triglycerides > 1.70 mmol/l, decreased HDL-cholesterol (< 1.0 mmol/l in men and < 1.3 mmol/l in women), systolic blood pressure > 130 mmHg or diastolic blood pressure > 85 mmHg, and FPG > 5.6 mmol/l.
• Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits.
• Willingness to discontinue consumption of fermented foods or probiotics (e.g. yoghourts, with live, active cultures or supplements).
• Able to provide informed consent.

Exclusion Criteria

• Concurrent consumption of fermented foods or probiotics (e.g. yoghourts, with live, active cultures or supplements). Subjects will be eligible for participation, however, after a two-week washout period
• Overt or documented vascular disease (coronary heart disease, cerebrovascular disease, or peripheral vascular disease).
• Participants suffering from dementia (mini mental state examination) or depression (geriatric depression scale).
• Concurrent statin therapy. (Statins have been shown to reduce vascular inflammation as measured by FDG-PET-see section 9.1).
• Color blind
• Concurrent antibiotic therapy. However, screened participants would be eligible to participate two weeks after completing their course of antibiotics (wash-out period).
• Known to be pregnant or breast-feeding or planning on becoming pregnant in the next 18 months.
• Women of childbearing potential not using effective contraception. Acceptable methods of birth control includes:
• Hormonal contraceptives including combined oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormonal implants;
• Intrauterine devices (IUD) or Intrauterine system (IUS);
• Tubal ligation;
• Vasectomy of partner;
• Double barrier method (use of physical barrier by both partners, e.g. male condom and diaphragm, male condom and cervical cap).
• Positive pregnancy test in women of childbearing potential.
• Allergy to milk, soy, or yeast.
• Use of another investigational product within 3 months of the screening visit.
• Claustrophobia
• Patient with pacemaker
• Patient with BMI greater than 40 kg/m2
• Immune disorder.
• Drug and alcohol abuse
• Current use of NSAIDs
• Liver and kidney disorders
• Bleeding/blood disorder

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lallemand Health Solutions

INDUSTRY

Sponsor Role: collaborator

Montreal Heart Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anil Nigam, MD

Role: PRINCIPAL_INVESTIGATOR

Montreal Heart Institute

Locations

Cardiovascular Prevention and Rehabilitation Center

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

2016-2038

Identifier Type: -

Identifier Source: org_study_id