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

Faculty of Medical Sciences, Clinical Hospital46 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Enrollment

Conditions

Type2 Diabetes

Interventions

Lactobacillus acidophilus 207, Bifidobacterium lactis B420/205DIETARY_SUPPLEMENT

Cultures containing 3.7 × 10 \^ 9 CFU/mg

Lactobacillus bulgaricus and Streptococcus thermophillusDIETARY_SUPPLEMENT

Cultures containing 3.7 × 10 \^ 6 CFU/mg

No cultureDIETARY_SUPPLEMENT

No probiotic cultures

Eligibility

Sex: ALLMin age: 25 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Instituto Maimonides de Investigacion Biomedica de Cordoba

Córdoba, Spain

Outcomes

Primary Outcomes

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.

Time frame: Baseline and week 12

Secondary Outcomes

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.

Time frame: 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.

Time frame: Baseline and week 12

Data from ClinicalTrials.gov

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