Probiotics for Vascular Inflammation in Metabolic Syndrome (PROMISE)

University of Montreal

Status: Completed

Conditions: Metabolic Syndrome

Treatments: Dietary Supplement: Probiotic supplement; Dietary Supplement: Placebo supplement

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03719794

2016-2038

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 2 patient groups, including a placebo group

Probiotics arm

Active Comparator group

Description:

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)

Treatment:

Dietary Supplement: Probiotic supplement

Placebo arm

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo supplement