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The purpose of the study is to analyze the effects of the consumption of yogurt with concentrated and lyophilized probiotic cultures on the parameters associated with glucose homeostasis, inflammation and oxidative stress in patients with Type 2 Diabetes Mellitus (T2DM).
After being informed about the study and the potential risks, all patients who gave their written informed consent underwent a screening period of 1 week to determine their eligibility to participate in the study. At week 0, patients who met the eligibility requirements were randomized in a double-blind manner (participant and investigator) to the American Diabetes Association (ADA) diet + yogurt with premium probiotics (300 g/d) or ADA diet + conventional yogurt (300 g/d) or ADA diet without fermented dairy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Premium probiotic yogurt | Experimental | Participants receive 300 g/d of yogurt with concentrated and freeze-dried probiotic cultures for 12 weeks. Also, the nutritional recommendations of the American Diabetes Association (ADA). |
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| Conventional yogurt | Experimental | Participants receive 300 g/d of conventional yogurt for 12 weeks. Also, the nutritional recommendations of the American Diabetes Association (ADA). |
|
| no fermented dairy | Experimental | Participants followed the American Diabetes Association (ADA) recommendations without including fermented dairy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus acidophilus 207, Bifidobacterium lactis B420/205 | Dietary Supplement | Cultures containing 3.7 × 10 ^ 9 CFU/mg |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in parameters associated with glucose homeostasis | At time 0 and after 12 weeks of intervention and follow-up, it was determined in mg/dL following the protocols established for: HDL-c (high-density lipoprotein cholesterol), LDL-c (low-density lipoprotein cholesterol), triglycerides and glucose. Likewise, glycosylated hemoglobin (HbA1c in percentage) was determined. | Baseline and week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in inflammatory parameters | At time 0 and after 12 weeks of intervention and follow-up, the high sensitivity C-reactive protein (hs-CRP) was determined in plasma in mg/dL. Likewise, interleukin-6 (IL-6) and tumor necrosis factor alpha (TNF-a) in ng/mL. | Baseline and week 12 |
| Changes in oxidative stress parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pablo Perez Martinez, MD | Instituto Maimonides de Investigacion Biomedica de Cordoba, Spain | Study Director |
| Maria Ruiz Diaz Narvaez, DN | Faculty of Medical Science, Paraguay | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Maimonides de Investigacion Biomedica de Cordoba | Córdoba | 14004 | Spain |
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| Lactobacillus bulgaricus and Streptococcus thermophillus | Dietary Supplement | Cultures containing 3.7 × 10 ^ 6 CFU/mg |
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| No culture | Dietary Supplement | No probiotic cultures |
|
Superoxide dismutase, glutathione peroxidase and catalase (SOD, GPx, CAT, respectively) will be measured in U/mg by spectrophotometry at time 0 and after 12 weeks of intervention and follow-up. |
| Baseline and week 12 |