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

Primary Purpose

Type2 Diabetes

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Lactobacillus acidophilus 207, Bifidobacterium lactis B420/205

Lactobacillus bulgaricus and Streptococcus thermophillus

No culture

About this trial

This is an interventional health services research trial for Type2 Diabetes focused on measuring probiotics, glucose homeostasis

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Instituto Maimonides de Investigacion Biomedica de Cordoba

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Premium probiotic yogurt

Conventional yogurt

no fermented dairy

Arm 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).

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT04988594

First Posted

June 16, 2021

Last Updated

July 26, 2021

Sponsor

Faculty of Medical Sciences, Clinical Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04988594

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

February 1, 2021 (Actual)

Primary Completion Date

April 30, 2021 (Actual)

Study Completion Date

April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Faculty of Medical Sciences, Clinical Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type2 Diabetes

Keywords

probiotics, glucose homeostasis

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Premium probiotic yogurt

Arm Type

Experimental

Arm 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).

Arm Title

Conventional yogurt

Arm Type

Experimental

Arm Description

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

Arm Title

no fermented dairy

Arm Type

Experimental

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Lactobacillus acidophilus 207, Bifidobacterium lactis B420/205

Intervention Description

Cultures containing 3.7 × 10 ^ 9 CFU/mg

Intervention Type

Dietary Supplement

Intervention Name(s)

Lactobacillus bulgaricus and Streptococcus thermophillus

Intervention Description

Cultures containing 3.7 × 10 ^ 6 CFU/mg

Intervention Type

Dietary Supplement

Intervention Name(s)

No culture

Intervention Description

No probiotic cultures

Primary Outcome Measure Information:

Title

Changes from baseline in parameters associated with glucose homeostasis

Description

Time Frame

Baseline and week 12

Secondary Outcome Measure Information:

Title

Changes in inflammatory parameters

Description

Time Frame

Baseline and week 12

Title

Changes in oxidative stress parameters

Description

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.

Time Frame

Baseline and week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pablo Perez Martinez, MD

Organizational Affiliation

Instituto Maimonides de Investigacion Biomedica de Cordoba, Spain

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Maria Ruiz Diaz Narvaez, DN

Organizational Affiliation

Faculty of Medical Science, Paraguay

Official's Role

Principal Investigator

Facility Information:

Facility Name

Instituto Maimonides de Investigacion Biomedica de Cordoba

City

Cordoba

ZIP/Postal Code

14004

Country

Spain

12. IPD Sharing Statement

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

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