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OpenTrials
Completed

NCT Number: NCT04988594

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).

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Key information

Conditions

Type2 Diabetes

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Maimonides de Investigacion Biomedica de Cordoba

Córdoba, 14004, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactobacillus acidophilus 207, Bifidobacterium lactis B420/205

Dietary Supplement

Cultures containing 3.7 × 10 ^ 9 CFU/mg

Lactobacillus bulgaricus and Streptococcus thermophillus

Dietary Supplement

Cultures containing 3.7 × 10 ^ 6 CFU/mg

No culture

Dietary Supplement

No probiotic cultures

Primary outcomes

  1. Changes from baseline in parameters associated with glucose homeostasis

    Time frame: 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 outcomes

  1. Changes in inflammatory parameters

    Time frame: 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.

  2. Changes in oxidative stress parameters

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Faculty of Medical Sciences, Clinical Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 3, 2021
Registry last updated
Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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