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

Faculty of Medical Sciences, Clinical Hospital

Status

Completed

Conditions

Type2 Diabetes

Treatments

Dietary Supplement: Lactobacillus bulgaricus and Streptococcus thermophillus

Dietary Supplement: Lactobacillus acidophilus 207, Bifidobacterium lactis B420/205

Dietary Supplement: No culture

Study type

Interventional

Funder types

Other

Identifiers

NCT04988594

FMSParaguay

Details and patient eligibility

About

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).

Full 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.

Enrollment

46 patients

Sex

All

Ages

25 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

46 participants in 3 patient groups

Premium probiotic yogurt

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Lactobacillus acidophilus 207, Bifidobacterium lactis B420/205

Conventional yogurt

Experimental group

Description:

Participants receive 300 g/d of conventional yogurt for 12 weeks. Also, the nutritional recommendations of the American Diabetes Association (ADA).

Treatment:

Dietary Supplement: Lactobacillus bulgaricus and Streptococcus thermophillus

no fermented dairy

Experimental group

Description:

Participants followed the American Diabetes Association (ADA) recommendations without including fermented dairy.