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To evaluate the effects of synbiotic supplementation on insulin resistance, and lipid profile in subjects with metabolic syndrome, in a randomized, double-blind, placebo-controlled pilot study, 38 subjects with metabolic syndrome will be supplemented with either synbiotic or placebo capsules twice/day for 28 weeks. Both the synbiotic (G1) and the placebo (G2) groups will be advised to follow an energy balanced diet and physical activity recommendations. Parameters related to metabolic syndrome and insulin resistance will be measured every 7 weeks during the study course.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synbiotic | Active Comparator | Each synbiotic capsule (Protexin, UK) contained 2 × 108 CFU of seven strains of friendly bacteria (Lactobacillus casei, Lactobacillus rhamnosus, Streptococcus thermophilus, Bifidobacterium breve, Lactobacillus acidophilus, Bifidobacterium longum, Lactobacillus bulgaricus), prebiotics (FOS [Fructooligosaccharide]), and probiotics culture (Magnesium stearate [source: mineral and vegetable], and vegetable capsule [hydroxypropyl methyl cellulose]) |
|
| Placebo | Placebo Comparator | 250 mg Maltodexterin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synbiotic | Dietary Supplement |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| HOMA-IR | 28 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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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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| ID | Term |
|---|---|
| D058616 | Synbiotics |
| ID | Term |
|---|---|
| D056692 | Prebiotics |
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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|
| D009750 |
| Nutritional and Metabolic Diseases |
| D010829 |
| Physiological Phenomena |
| D019936 | Probiotics |
| D019602 | Food and Beverages |