probiotic in diabetes

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 68

Inclusion Criteria

Age between50 - 65 years
Type 2 diabetic patients that diagnosed at least 2 years ago.
BMI between 25 – 34.9 kg/m2
The patient or caregiver understands the objectives of the study and agrees to follow the necessary rules throughout the study.

Exclusion Criteria

Irregular diet and unstable body weight (body-weight change > 5% within 3 months before screening)
Type 1 diabetes or non-diabetic patients
History of Cardiovascular disease, Hypertension, heart attack, angina pectoris, cerebrovascular disease, stroke, Thyroid disease, and other chronic diseases and transmitted diseases in the past year.
Dietary supplementation of probiotics within 6 months before screening
Pregnancy or breast-feeding
Use of smoke and alcohol during the last three months prior the study.
Consumption of medication that affects body weight, energy expenditure, glucose control, or antibiotic treatment within 3 months before screening.
using any drug other than metformin, sulfonylurea, statins, angiotensin-converting enzyme inhibitors (ACEI), angiotensin receptor blockers (ARB), and aspirin at doses of 80?mg or less
Changing in medications received in the previous three months.
Having any allergic reaction after our intervention.
Participants who consume less than 80% of the supplement.
Further exclusion criteria are acute or chronic infections, liver disease, kidney disease, gastrointestinal disease, or any other acute or chronic disease requiring treatment.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ipoprotein-associated phospholipase A2 (Lp-PLA2). Timepoint: before intervention and 12 weeks after intervention. Method of measurement: using a lab kit to measure Lp-PLA2.

Secondary Outcome Measures

Name	Time	Method
Glycemic Index(Fasting Blood Sugar, Glycosylated Hemoglobin). Timepoint: before intervention and 12 weeks after intervention. Method of measurement: enzymatic colorimetric method.;Lipid Profile (TC, TG, HDL, LDL). Timepoint: before intervention and 12 weeks after intervention. Method of measurement: enzymatic colorimetric method.;HOMA-IR. Timepoint: before intervention and 12 weeks after intervention. Method of measurement: Calculating by formula: HOMA-IR=(glucose(mg/dl)× Insulin(µU/ml))/22.5.;Weight. Timepoint: before intervention and 12 weeks after intervention. Method of measurement: standard scale.;Waist circumference. Timepoint: before intervention and 12 weeks after intervention. Method of measurement: non-stretching tape.;Body composition. Timepoint: before intervention and 12 weeks after intervention. Method of measurement: Bioelectrical Impedance Analysis.