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

Not Applicable

Completed

• Conditions: Type2 Diabetes

• Registration Number: NCT04988594
• Lead Sponsor: Faculty of Medical Sciences, Clinical Hospital

Brief Summary

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

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 Timeline

• Study Start: 2021-02-01
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30
• Study First Submitted: 2021-06-16
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-26
• Last Update Submitted: 2021-07-26
• Study First Posted: 2021-08-03
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Changes from baseline in parameters associated with glucose homeostasis	Baseline and week 12	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.

Secondary Outcome Measures

Name	Time	Method
Changes in inflammatory parameters	Baseline and week 12	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.
Changes in oxidative stress parameters	Baseline and week 12	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.

Trial Locations

Locations (1)

Instituto Maimonides de Investigacion Biomedica de Cordoba; 🇪🇸 Cordoba, Spain