Effects of Yogurt With Probiotics in Adults With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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A 12-weeks Double Blind Trial of Effects of Yogurt With Probiotics in Adults With Type 2 Diabetes Mellitus

Conditions
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Type2 Diabetes

Intervention / Treatment
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* Dietary Supplement: Lactobacillus acidophilus 207, Bifidobacterium lactis B420/205
* Dietary Supplement: Lactobacillus bulgaricus and Streptococcus thermophillus
* Dietary Supplement: No culture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with T2DM diagnosed at least one year ago. That they are outpatients. Between 25 and 65 years old. Exclusion Criteria: Smoking patients. Lactose intolerance. Pregnancy or breastfeeding. Presence of kidney, liver, immunodeficiency, inflammatory bowel disease or thyroid disorder. Use of insulin, estrogen, progesterone or diuretic injections. Consumption of probiotic supplements two months before the start of the study

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Premium probiotic yogurt<br>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). | Dietary Supplement: Lactobacillus acidophilus 207, Bifidobacterium lactis B420/205<br>* Cultures containing 3.7 × 10 ^ 9 CFU/mg<br>|
| Experimental: Conventional yogurt<br>Participants receive 300 g/d of conventional yogurt for 12 weeks. Also, the nutritional recommendations of the American Diabetes Association (ADA). | Dietary Supplement: Lactobacillus bulgaricus and Streptococcus thermophillus<br>* Cultures containing 3.7 × 10 ^ 6 CFU/mg<br>|
| Experimental: no fermented dairy<br>Participants followed the American Diabetes Association (ADA) recommendations without including fermented dairy. | Dietary Supplement: No culture<br>* No probiotic cultures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotics, glucose homeostasis