A 12-weeks Double Blind Trial of Effects of Yogurt With Probiotics in Adults With Type 2 Diabetes Mellitus
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 46
- Locations
- 2
- Primary Endpoint
- Changes from baseline in parameters associated with glucose homeostasis
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Health Services Research
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 25 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
- Changes in inflammatory parameters(Baseline and week 12)
- Changes in oxidative stress parameters(Baseline and week 12)
Investigators
Maria Eugenia Ruiz Diaz Narvaez
Clinical Nutritionist
Faculty of Medical Sciences, Clinical Hospital