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IRCT20090822002365N25 IRCT 2021-03-03 Iran University of Medical Sciences Effect of synbiotic with or without vitamin D on intestinal microbiome Effect of synbiotic and/or vitamin D on intestinal microbiome and its relationship with muscle strength, function and body composition in overweight or obese middle-aged women. 2021-04-21 anticipated 88 Complete https://irct.ir/trial/54342 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: For randomized allocation performing, permuted block randomization will be used by quadrilateral blocks. According to the sample size of 88 subjects, 22 blocks will be generated using the online site (www.sealedenvelope.com). In order to allocation concealment in the randomized process, unique codes will be used on the drug boxes that is generated by the software. Participants will be entered into study based on the produced sequence. The drug packets will be allocated to the individual with code on them. Therefore, participants will be unaware of the type of intervention that will receive, as well as the random sequence which will be hidden and unpredictable, Blinding description: For blinding, a person who will not be involved in study protocol will create the randomization list assigning participants to the vitamin D, synbiotic, co-supplementation or the placebo group. Vitamin D, synbiotic, and placebo tablets will be placed into identical containers and all investigators, and participants will be blinded to the random assignments. 2-3 overweight or obese middle-aged women. Intervention 1: Intervention group 1: Receiving one capsule of 50,000 IU of vitamin D (Zahravi company) weekly, along with one capsule of synbiotic placebo containing maltodextrin (Zist takhmir company) daily, for 8 weeks. Intervention 2: Intervention group 2: Receiving a 500 mg synbiotic capsule (Zist takhmir Company) daily, along with a vitamin D placebo capsule containing paraffin (Zahravi Company) weekly, for 8 weeks. Intervention 3: Intervention group 3: Receiving one 50,000 IU capsule of Vitamin D (Zahravi Company) weekly, along with receiving one 500 mg synbiotic capsule (Zist takhmir Company) daily, for 8 weeks. Intervention 4: Control group: Receiving a vitamin D placebo capsule containing paraffin (Zahravi Company) weekly, along with one capsule of synbiotic placebo containing maltodextrin (Zist takhmir company) daily, for 8 weeks. Yes - There is a plan to make this available What will be shared: A part of the data will be shared, such as primary outcomes. When: Four months after the publication of the results. To whom: Researchers and students of university. Conditions: Four months after the publication of this study papers, the obtained data will be available to the applicant researchers and students for further analysis. Where to obtain: Applicants can be contacted with corresponding author by e-mail or postal address to receive the requested data. Postal address: Nutrition Department, School of health, Iran University of Medical Science, Hemmat Expressway, Tehran Phone Number: 0098 2186704743 E-mail: rezavafa@yahoo.com How to obtain: Applicants can be contacted with corresponding author by e-mail or postal address to receive the requested data. Postal address: Nutrition Department, School of health, Iran University of Medical Science, Hemmat Expressway, Tehran Phone Number: 0098 2186704743 E-mail: rezavafa@yahoo.com Comments:
public Mohammad reza Vafa
Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Hemmat Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4734 vafa.m@iums.ac.ir Iran University of Medical Sciences scientific Mohammad reza Vafa
Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Hemmat Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4734 vafa.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Overweight and obese women aged 40-55 years Not being menopaused Body mass index higher than 25 kg/m2 Willingness to participate in the study 40 years 55 years Female Vitamin D intake during the last 2-3 months, either orally or by injection Taking supplements of synbiotics, probiotics and prebiotics during the last 2-3 months Having chronic diseases such as diabetes, cardiovascular disease, uncontrolled blood pressure, liver and kidney disorders, etc. Supplements intake containing vitamins, minerals and omega-3 or fish oil Antibiotic intake during the last three weeks Following a special diet Using steroidal and non-steroidal anti-inflammatory drugs, anticonvulsants, anti-cholesterol drugs, antacids, diuretics and and laxatives over the past two months Using any medications that affect weight over the past two months (such as medications that affect carbohydrate, protein or fat metabolism, and medications that reduce or increase appetite or food intake). E66 Overweight and obesity Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: Receiving one capsule of 50,000 IU of vitamin D (Zahravi company) weekly, along with one capsule of synbiotic placebo containing maltodextrin (Zist takhmir company) daily, for 8 weeks. Intervention group 2: Receiving a 500 mg synbiotic capsule (Zist takhmir Company) daily, along with a vitamin D placebo capsule containing paraffin (Zahravi Company) weekly, for 8 weeks. Intervention group 3: Receiving one 50,000 IU capsule of Vitamin D (Zahravi Company) weekly, along with receiving one 500 mg synbiotic capsule (Zist takhmir Company) daily, for 8 weeks. Control group: Receiving a vitamin D placebo capsule containing paraffin (Zahravi Company) weekly, along with one capsule of synbiotic placebo containing maltodextrin (Zist takhmir company) daily, for 8 weeks. Intestinal microbiome. Timepoint: Intestinal microbiome assessment at the beginning of the study and after the intervention (end of week 8). Method of measurement: Real-Time PCR TaqMan method. Muscle strength. Timepoint: At the beginning of the study and after the intervention (end of week 8). Method of measurement: handgrip strength and knee extension. Muscle function. Timepoint: At the beginning of the study and after the intervention (end of week 8). Method of measurement: TGUG test. Body composition. Timepoint: At the beginning of the study and after the intervention (end of week 8). Method of measurement: multi-frequency Bioelectrical Impedance Analysis (BIA) and InBody S10 analyzer. Vice chancellor for research, Iran University of Medical Sciences Approved 2021-01-31 Ethics committee of Iran University of Medical Sciences Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)