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

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).

Study Overview

• Status: Completed
• Conditions: Type2 Diabetes
• Intervention / Treatment: Dietary supplement: Lactobacillus acidophilus 207, Bifidobacterium lactis B420/205; Dietary supplement: Lactobacillus bulgaricus and Streptococcus thermophillus; Dietary supplement: No culture

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 Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Cordoba, Spain, 14004
    • Instituto Maimónides de Investigación Biomédica de Córdoba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Premium probiotic yogurt; 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).	Dietary supplement: Lactobacillus acidophilus 207, Bifidobacterium lactis B420/205; Cultures containing 3.7 × 10 ^ 9 CFU/mg
EXPERIMENTAL: Conventional yogurt; Participants receive 300 g/d of conventional yogurt for 12 weeks. Also, the nutritional recommendations of the American Diabetes Association (ADA).	Dietary supplement: Lactobacillus bulgaricus and Streptococcus thermophillus; Cultures containing 3.7 × 10 ^ 6 CFU/mg
EXPERIMENTAL: no fermented dairy; Participants followed the American Diabetes Association (ADA) recommendations without including fermented dairy.	Dietary supplement: No culture; No probiotic cultures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Faculty of Medical Sciences, Clinical Hospital
• Investigators: Study Director: Pablo Perez Martinez, MD, Instituto Maimonides de Investigacion Biomedica de Cordoba, Spain; Principal Investigator: Maria Ruiz Diaz Narvaez, DN, Faculty of Medical Science, Paraguay

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2021
• Primary Completion (ACTUAL): April 30, 2021
• Study Completion (ACTUAL): April 30, 2021

Study Registration Dates

• First Submitted: June 16, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (ACTUAL): August 3, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 3, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: probiotics; glucose homeostasis
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: FMSParaguay

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No