Probiotics for Vascular Inflammation in Metabolic Syndrome

NCT03719794 | Completed

• 1 other identifier: 2016-2038
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The primary outcome is to evaluate the change on vascular inflammation (measured by FDG-PET), so as to test the hypothesis that probiotic treatment reduces vascular inflammation in comparison to placebo.

  PET-CT scan of the carotid arteries and ascending thoracic aorta will be performed 2 hours post I.V. The participant will be injected with 18F-FDG.

  At baseline and following 12 weeks of probiotic supplementation or placebo.

Secondary Outcomes (5)

• Mesure of High-sensitivity C-reactive protein (hs-CRP) a systemic inflammatory marker.

  At baseline and following 12 weeks of probiotic supplementation or placebo.

• Mesure of Tumor necrosis factor alpha (TNF-α) a systemic inflammatory marker.

  At baseline and following 12 weeks of probiotic supplementation or placebo.

• Mesure of Matrix metallopeptidase 9 (MMP-9)

  At baseline and following 12 weeks of probiotic supplementation or placebo.

• Cognitive function at rest by a standard pen-paper battery test.

  At baseline and following 12 weeks of probiotic supplementation or placebo.

• Intestinal microbiota community composition

  At baseline and following 12 weeks of probiotic supplementation or placebo.

Other Outcomes (2)

• Mesure of blood fasting glucose

  At baseline and following 12 weeks of probiotic supplementation or placebo.

• Mesure of blood Serum lipids

  At baseline and following 12 weeks of probiotic supplementation or placebo.

Study Arms (2)

Probiotics arm

ACTIVE COMPARATOR

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)

Dietary Supplement: Probiotic supplement

Placebo arm

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo supplement

Interventions

Probiotic supplement DIETARY_SUPPLEMENT

Probiotic supplement once daily (xyz) for 12 weeks

Probiotics arm

Placebo supplement DIETARY_SUPPLEMENT

Placebo supplement once daily for 12 weeks

Placebo arm

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montreal Heart Institute: lead
• Lallemand Health Solutions: collaborator

Study Sites (1)

Cardiovascular Prevention and Rehabilitation Center

Montreal, Quebec, H1T 1N6, Canada

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Anil Nigam, MD

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: October 25, 2018
• Study Start: April 16, 2018
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: January 14, 2021

Record last verified: 2021-01

Locations

CA (1)