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IRCT20130211012438N35 IRCT 2023-06-06 Kashan University of Medical Sciences The effect of magnesium and zinc and probiotic co-supplementation in patients with coronary heart disease and type 2 diabetes mellitus Study of the effect of magnesium and zinc and probiotic co-supplementation on metabolic profiles in patients with coronary heart disease and type 2 diabetes mellitus 2019-01-05 anticipated 60 Complete https://irct.ir/trial/36200 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of randomization is that the patients are placed on separate classes according to two criteria: BMI (BMI <25 BMI≥25) and age (<65 and 65≤), and then randomly in one of Two groups receiving magnesium and zinc supplements, and probiotics, and the placebo group (containing starch) are included. The study is done using the Stat Trek software, Blinding description: Supplements and placebo after coding by the researcher are placed under supervision of clinical caregiver and then clinical caregiver provided them to the participants. Both clinical caregiver and participants are kept blind. N/A coronary heart disease and type 2 diabetes mellitus. Intervention 1: Intervention group: A capsule containing 150 mg zinc sulfate and 250 mg magnesium oxide and a probiotic capsule (containing Lactobacillus acidophilus 109 × 1.8, Bifidobacterium bifidum 109 × 1.8, Bifidobacterium lactis 109 × 1.8 and Bifidobacterium Langum 109 x 1.8 CFU) Once a day for 3 months. Intervention 2: Control group: 1000 mg Placebo capsule containing corn starch once a day for 3 months. Yes - There is a plan to make this available What will be shared: A portion of the data regarding demographics, anthropometric, and food variables, that are collected at the baseline of the study, and also the information on the main outcome will be shared. When: The start of the data access period will be one year after the publication of the results To whom: Researchers working in academic institutions Conditions: In order to conduct meta analysis studies Where to obtain: Mohsen Taghizadeh, Nutrition Department, School of Medicine, Kashan University of Medical Sciences, Qotbe-e-Ravandi Blvd., Kashan, Iran Postal Code: 88715973474 E-mail: sharifi-na@kaums.ac.ir Tel: 00983155540021 Fax: 00983155620608 How to obtain: An applicant can send a request for a data file by e-mail. After reviewing the request, the data file will be sent to him/her after about three weeks would have passed from the date of the request Comments:
public zahra Hamedifard
Kashan University of Medical Sciences, Pezeshk Ave., Qotb-e-Ravandi Blvd.
Kashan Iran (Islamic Republic of) 88715973474 +98 31 5554 0021 z.hamedifard.sb@gmail.com Kashan University of Medical Sciences scientific mohsen taghizadeh
Kashan University of Medical Sciences, Kashan, Iran
Kashan Iran (Islamic Republic of) 8719675537 +98 31 5533 3213 taghizadeh_m@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Coronary heart disease patients diagnosed with angiography; Patients with diabetes according to American Diabetes Association criteria; age 40 to 95 years; No smoking 40 years 95 years Both Thyroid disease; Infection; Consumption of any type of supplement (vitamin, salts, etc.) in the last 3 months; Acute myocardial infarction in the last 3 months; Cardiac surgery in the last 3 months; Significant kidney failure; Significant liver failure; Unwillingness to cooperate; Antibiotic use during study I25.9 Chronic ischemic heart disease, unspecified Treatment - Drugs Placebo Intervention group: A capsule containing 150 mg zinc sulfate and 250 mg magnesium oxide and a probiotic capsule (containing Lactobacillus acidophilus 109 × 1.8, Bifidobacterium bifidum 109 × 1.8, Bifidobacterium lactis 109 × 1.8 and Bifidobacterium Langum 109 x 1.8 CFU) Once a day for 3 months Control group: 1000 mg Placebo capsule containing corn starch once a day for 3 months Insulin resistance. Timepoint: Baseline and End-of-trial. Method of measurement: Calculate with HOMA formula. Fasting plasma glucose. Timepoint: Baseline and end of the trial. Method of measurement: Enzymatic. Insulin. Timepoint: Baseline and end of the trial. Method of measurement: Elisa. Insulin sensitivity. Timepoint: Baseline and end of the trial. Method of measurement: Calculate with QUICKI formula. HbA1c. Timepoint: Baseline and end of the trial. Method of measurement: Laboratory clinical kit. Nitric oxide (NO). Timepoint: Baseline and end of the trial. Method of measurement: Spectrophotometry. High sensitivity C-reactive protein (hs-CRP). Timepoint: Baseline and end of the trial. Method of measurement: Elisa. Total Antioxidant Capacity (TAC). Timepoint: Baseline and end of the trial. Method of measurement: Spectrophotometry. Total glutathione. Timepoint: Baseline and end of the trial. Method of measurement: Spectrophotometry. Malondialdehyde (MDA). Timepoint: Total glutathione. Method of measurement: Spectrophotometry. Serum Total cholestrol. Timepoint: Baseline and end of the trial. Method of measurement: Laboratory clinical kit. Serum LDL-C. Timepoint: Baseline and end of the trial. Method of measurement: Laboratory clinical kit. HDL-C سرم. Timepoint: Baseline and end of the trial. Method of measurement: Laboratory clinical kit. Serum Triglyceride. Timepoint: Baseline and end of the trial. Method of measurement: Laboratory clinical kit. Kashan University of Medical Sciences Approved 2018-12-10 Ethics Committee of Kashan University of Medical Sciences Kashan University of Medical Sciences, Pezeshk Ave., Qotb-e-Ravandi Blvd. Kashan Isfehan Iran (Islamic Republic of)