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

NCT04988594 | Completed DMC

• 1 other identifier: FMSParaguay
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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).

Conditions

Type2 Diabetes

Keywords

probiotics; glucose homeostasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes in inflammatory parameters

  Baseline and week 12

• Changes in oxidative stress parameters

  Baseline and week 12

Study Arms (3)

Premium probiotic yogurt

EXPERIMENTAL

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

Conventional yogurt

EXPERIMENTAL

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

no fermented dairy

EXPERIMENTAL

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

Dietary Supplement: No culture

Interventions

Lactobacillus acidophilus 207, Bifidobacterium lactis B420/205 DIETARY_SUPPLEMENT

Cultures containing 3.7 × 10 \^ 9 CFU/mg

Premium probiotic yogurt

Lactobacillus bulgaricus and Streptococcus thermophillus DIETARY_SUPPLEMENT

Cultures containing 3.7 × 10 \^ 6 CFU/mg

Conventional yogurt

No culture DIETARY_SUPPLEMENT

No probiotic cultures

no fermented dairy

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with T2DM diagnosed at least one year ago.
• That they are outpatients.
• Between 25 and 65 years old.

You may not qualify if:

• 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

Sponsors & Collaborators

• Faculty of Medical Sciences, Clinical Hospital: lead

Study Sites (1)

Instituto Maimonides de Investigacion Biomedica de Cordoba

Córdoba, 14004, Spain

Location

Study Officials

• Pablo Perez Martinez, MD

  Instituto Maimonides de Investigacion Biomedica de Cordoba, Spain

  STUDY DIRECTOR

• Maria Ruiz Diaz Narvaez, DN

  Faculty of Medical Science, Paraguay

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Nutritionist

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: August 3, 2021
• Study Start: February 1, 2021
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-07

Locations

ES (1)