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IRCT20210529051435N1 IRCT 2022-02-24 Tehran University of Medical Sciences probiotic in diabetes Lp-PLA2 , T2D Effect of probiotic supplementation on lipoprotein-associated phospholipase A2 in type 2 diabetic patients 2022-02-20 anticipated 68 Complete https://irct.ir/trial/56566 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: This study is a double-blind, randomized, parallel, placebo-controlled clinical trial. Sixty-eight diabetic patients are randomly allocated in a ratio of 1: 1 into the intervention and control groups by permuted block randomization. We used stratified randomization to match participants based on sex and menopausal in both groups, Blinding description: This study is double-blind, Participants will be divided into two groups receiving probiotic supplement (n=34) and placebo groups (n=34) by the balanced randomized blocked method. Suppelemnts will be either placebo (Placebo; containing starch and inactive ingredient excipients) or probiotics with dosages of Bacillus Coagulans, Lactobacillus Plantarum, Lactobacillus acidophilus, and Bifidobacterium Bifdum, 3 billion/capsules (3×109 colony forming units (CFU) per capsule). Both probiotics and placebo capsules will be produced and coded by Takgene Zist pharmaceutical company. The packaging, odor, and appearance of a placebo containing Biodiab are just similar to the supplement containing Biodiab. 1-2 Type 2 Diabetes Mellitus. Intervention 1: Intervention group: This study of patients with type 2 diabetes referred to the Shar hospital, Sulaymaniyah, Iraq, which has the inclusion criteria, at the beginning of the study goals, will be explained to participants,s and then written consent will be obtained from all-volunteer patients. Participants will be divided into two groups receiving probiotic supplements (n=34) and placebo groups (n=34) by the balanced randomized blocked method. Supplements will be probiotics with dosages of Bacillus Coagulans, Lactobacillus Plantarum, Lactobacillus acidophilus, and Bifidobacterium bifidum, 3 billion/capsules (3×109 colony forming units (CFU) per capsule). The probiotic capsules will be produced and coded by Takgene Zist pharmaceutical company. The timeframe for intervention will be 12 weeks. Intervention 2: Control group: The placebo group (n=34) (Placebo; containing starch and inactive ingredient excipients) The placebo capsules will be produced and coded by Takgene Zist pharmaceutical company.• The packaging, odor, and appearance of placebo containing Biodiab are just similar to the supplement containing Biodiab.• Each Capsule will be taken orally with a full glass of water.• Participants from each group will take one Biodiab capsule daily. The timeframe for intervention will be 12 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Salman Salih Mohammed Jaff
Door 35,Building B4, Shari mamostayan, Shorish street, Sulaymaniyah, Iraq
Sulaymaniyah Iraq 46001 +964 53 328 8335 Salmanjaff86@gmail.com Tehran University of Medical Sciences scientific Kurosh Djafarian
keshavarz blvd
Tehran Iran (Islamic Republic of) 1417653911 +98 21 8895 5975 kdjafarian@tums.ac.ir Tehran University of Medical Sciences Iraq 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. 50 years 65 years Both 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. E11 Type 2 diabetes mellitus Treatment - Other Placebo Intervention group: This study of patients with type 2 diabetes referred to the Shar hospital, Sulaymaniyah, Iraq, which has the inclusion criteria, at the beginning of the study goals, will be explained to participants,s and then written consent will be obtained from all-volunteer patients. Participants will be divided into two groups receiving probiotic supplements (n=34) and placebo groups (n=34) by the balanced randomized blocked method. Supplements will be probiotics with dosages of Bacillus Coagulans, Lactobacillus Plantarum, Lactobacillus acidophilus, and Bifidobacterium bifidum, 3 billion/capsules (3×109 colony forming units (CFU) per capsule). The probiotic capsules will be produced and coded by Takgene Zist pharmaceutical company. The timeframe for intervention will be 12 weeks. Control group: The placebo group (n=34) (Placebo; containing starch and inactive ingredient excipients) The placebo capsules will be produced and coded by Takgene Zist pharmaceutical company.• The packaging, odor, and appearance of placebo containing Biodiab are just similar to the supplement containing Biodiab.• Each Capsule will be taken orally with a full glass of water.• Participants from each group will take one Biodiab capsule daily. The timeframe for intervention will be 12 weeks. Lipoprotein-associated phospholipase A2 (Lp-PLA2). Timepoint: before intervention and 12 weeks after intervention. Method of measurement: using a lab kit to measure Lp-PLA2. 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. Tehran University of Medical Sciences Approved 2021-09-21 ethics committee of school of medicine - Tehran university of medical sciences Number 44, East Hojjatdoust, Naderi St., School of Nutritional Sciences and Dietetics Tehran Tehran Iran (Islamic Republic of)