Effects of Yogurt With Probiotics in Adults With Type 2 Diabetes Mellitus
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Changes from baseline in parameters associated with glucose homeostasis [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 Outcome Measures
- Changes in inflammatory parameters [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.
- Changes in oxidative stress parameters [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients with T2DM diagnosed at least one year ago.
-
That they are outpatients.
-
Between 25 and 65 years old.
Exclusion Criteria:
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Smoking patients.
-
Lactose intolerance.
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Pregnancy or breastfeeding.
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Presence of kidney, liver, immunodeficiency, inflammatory bowel disease or thyroid disorder.
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Use of insulin, estrogen, progesterone or diuretic injections.
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Consumption of probiotic supplements two months before the start of the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Instituto Maimonides de Investigacion Biomedica de Cordoba | Cordoba | Spain | 14004 |
Sponsors and Collaborators
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- FMSParaguay