The effect of yogurt and probiotic supplement on the cognitive function of patients with type 2 diabetes

Phase 3

• Conditions: Type 2 diabetes mellitus.; Type 2 diabetes mellitus

• Registration Number: IRCT20220621055238N1
• Lead Sponsor: Iran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 February 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

50 to 69 years of age
Body mass index equal to and greater than 25 to 40
Blood pressure under control (lower than 140/90 mmHg) in the last two months
The score of a brief cognitive screening test (Mini-Cog) lower or equal of 2
Daily consumption of yogurt at least one serving
Education level of at least five classes
Hb-A1c equal to and less than 8.5
Type 2 diabetes (at least two years)
Willingness to cooperate

Exclusion Criteria

Immune deficiency diseases
Stage three and above of Chronic Kidney Disease (CKD)
History of heart attack, congestive heart failure, stent placement
Chronic Obstructive Pulmonary Disease (COPD)
Stage three and above of fatty liver
Inflammatory Bowel Disease (IBD), Irritable Bowel Syndrome (IBS), pernicious anemia and mal-absorption such as celiac disease and chronic pancreatitis
Hypothalamic tumor
Uncontrolled thyroid disease
Parathyroid disease
Adrenal disease
Gum surgery under the supervision of a dentist
Gastrointestinal surgeries
Less than two years recovering from cancer
Less than 3 months recovering from Covid-19
Neurological diseases such as seizures, mental retardation and stroke
Comorbid psychiatric disorder such as Generalized Anxiety Disorder (GAD), depression, schizophrenia, dementia, Parkinson's Diseases, and bipolar
Allergy
Uncontrolled hypertriglyceridemia
Allergy to cow's milk protein
lactose intolerance
Taking any medication other than oral medications for diabetes, blood pressure, dyslipidemia, aspirin, and levothyroxine in the last two months
Taking antibiotics
Having a special diet
Regular consumption of dietary supplements (equal to or more than 3 times a week) other than vitamin D during the two months before the study
alcohol consumption
smoking
Being pregnant or breastfeeding
Participating in other medical studies

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The score of the brief cognitive screening test (Mini-cog). Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (end of week 12). Method of measurement: Mini-cog, a brief cognitive screening test.;The score of Stroop color-word. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (end of week 12). Method of measurement: Stroop color-word test.

Secondary Outcome Measures

Name	Time	Method
Salivary cortisol. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (end of week 12). Method of measurement: Immunoassay kit.;Superoxide Dismutase (SOD). Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (end of week 12). Method of measurement: ELISA kit.