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| Name | Class |
|---|---|
| Lallemand Health Solutions | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Placebo arm | Placebo Comparator | The placebo comparator arm will be of a 12-week placebo supplement regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic supplement | Dietary Supplement | Probiotic supplement once daily (xyz) for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mesure of High-sensitivity C-reactive protein (hs-CRP) a systemic inflammatory marker. | Change with hs-CRP | At baseline and following 12 weeks of probiotic supplementation or placebo. |
| Mesure of Tumor necrosis factor alpha (TNF-α) a systemic inflammatory marker. |
| Measure | Description | Time Frame |
|---|---|---|
| Mesure of blood fasting glucose | Change in fasting glucose | At baseline and following 12 weeks of probiotic supplementation or placebo. |
| Mesure of blood Serum lipids | Change in serum lipids |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anil Nigam, MD | Montreal Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Prevention and Rehabilitation Center | Montreal | Quebec | H1T 1N6 | Canada |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Placebo supplement | Dietary Supplement | Placebo supplement once daily for 12 weeks |
|
Change with TNF-α |
| At baseline and following 12 weeks of probiotic supplementation or placebo. |
| Mesure of Matrix metallopeptidase 9 (MMP-9) | Change with MMP-9 | At baseline and following 12 weeks of probiotic supplementation or placebo. |
| Cognitive function at rest by a standard pen-paper battery test. | Cognitive functions will be measured at rest with a pen-paper battery test by a neuropsychologist. The investigators will measure change of score to the cognitive tests. | At baseline and following 12 weeks of probiotic supplementation or placebo. |
| Intestinal microbiota community composition | To evaluate the impact on intestinal microbiota community composition | At baseline and following 12 weeks of probiotic supplementation or placebo. |
| At baseline and following 12 weeks of probiotic supplementation or placebo. |
| D009750 |
| Nutritional and Metabolic Diseases |