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

Type2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04988594
• Other study ID #: FMSParaguay
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: April 30, 2021

Study information

• Verified date: July 2021
• Source: Faculty of Medical Sciences, Clinical Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Dietary Supplement:
• Lactobacillus acidophilus 207, Bifidobacterium lactis B420/205
Cultures containing 3.7 × 10 ^ 9 CFU/mg
• Lactobacillus bulgaricus and Streptococcus thermophillus
Cultures containing 3.7 × 10 ^ 6 CFU/mg
• No culture
No probiotic cultures

Locations

Country	Name	City	State
Spain	Instituto Maimonides de Investigacion Biomedica de Cordoba	Cordoba

Sponsors (1)

Lead Sponsor	Collaborator
Faculty of Medical Sciences, Clinical Hospital

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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