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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04988594

Enrollment

Registered

2021-08-03

Start date

2021-02-01

Completion date

2021-04-30

Last updated

2021-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type2 Diabetes

Keywords

probiotics, glucose homeostasis

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.

Interventions

DIETARY_SUPPLEMENTLactobacillus acidophilus 207, Bifidobacterium lactis B420/205

Cultures containing 3.7 × 10 \^ 9 CFU/mg

DIETARY_SUPPLEMENTLactobacillus bulgaricus and Streptococcus thermophillus

Cultures containing 3.7 × 10 \^ 6 CFU/mg

DIETARY_SUPPLEMENTNo culture

No probiotic cultures

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

25 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026