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

NCT ID: NCT04988594

Last Updated: 2021-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2021-04-30

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.

Conditions

Type2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Lactobacillus acidophilus 207, Bifidobacterium lactis B420/205

Intervention Type: DIETARY_SUPPLEMENT

Cultures containing 3.7 × 10 \^ 9 CFU/mg

Conventional yogurt

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

Group Type: EXPERIMENTAL

Lactobacillus bulgaricus and Streptococcus thermophillus

Intervention Type: DIETARY_SUPPLEMENT

Cultures containing 3.7 × 10 \^ 6 CFU/mg

no fermented dairy

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

Group Type: EXPERIMENTAL

No culture

Intervention Type: DIETARY_SUPPLEMENT

No probiotic cultures

Interventions

Lactobacillus acidophilus 207, Bifidobacterium lactis B420/205

Cultures containing 3.7 × 10 \^ 9 CFU/mg

Intervention Type: DIETARY_SUPPLEMENT

Lactobacillus bulgaricus and Streptococcus thermophillus

Cultures containing 3.7 × 10 \^ 6 CFU/mg

Intervention Type: DIETARY_SUPPLEMENT

No culture

No probiotic cultures

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Faculty of Medical Sciences, Clinical Hospital

OTHER

Sponsor Role: lead

Responsible Party

Maria Eugenia Ruiz Diaz Narvaez

Clinical Nutritionist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pablo Perez Martinez, MD

Role: STUDY_DIRECTOR

Instituto Maimonides de Investigacion Biomedica de Cordoba, Spain

Maria Ruiz Diaz Narvaez, DN

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medical Science, Paraguay

Locations

Instituto Maimonides de Investigacion Biomedica de Cordoba

Córdoba, , Spain

Countries

Spain

Other Identifiers

FMSParaguay

Identifier Type: -

Identifier Source: org_study_id