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IRCT20220414054536N1 IRCT 2022-06-06 Shiraz University of Medical Sciences Effect of egg white protein and zinc-enriched synbiotic supplement in Sarcopenic Elderly Comparison of the effectiveness of the egg white protein and zinc-enriched synbiotic supplement and placebo on the muscle strength, muscle mass and quality of life in older adults with sarcopenia 2022-04-20 anticipated 72 Complete https://irct.ir/trial/62995 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: It should be noted that dietary intake and physical activity will be recorded in the study to investigate the confounding factors, Randomization description: Randomization of participants into placebo and target groups will be done by permuted block randomization. In this way, the size of block is considered 6 and all possible scenarios will be written for the two intervention and control groups, and this will be repeated until the number reaches 72. The method of concealing the allocation is to use a non-transparent sealed envelope in which each of the random entries created is recorded on a card and the cards are arranged inside the envelopes. At the beginning of the registration of participants, based on the order of entry of eligible participants to study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed, Blinding description: All participants in this study are unaware about their grouping because the appearance of the target and placebo are quite similar. Participants are not referred based on their group to clinical follow-up and outcome evaluator and he/she is also unaware of the separation of individuals. The principle investigators are not directly connected with the participants, so they are not aware of their grouping. An importer of data will also be outside the study system, which is generally unaware of the nature of the study. 3 Sarcopenia. Intervention 1: Intervention group: Receiving egg white protein (Gol Powder Golestan Co, Iran) and zinc (Zahravi Pharm Co, Iran)-enriched synbiotic (Pardis Roshd Mehregan Co, Iran) powder daily for 8 weeks. Intervention 2: Control group: Receiving Placebo powder (Pardis Roshd Mehregan Co, Iran) daily for 8 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 Dr. Mohammad Hossein Dabbaghmanesh
Shiraz University of Medical Sciences, Zand Street
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3235 7282 dabbaghmanesh@gmail.com Shiraz University of Medical Sciences scientific Dr. Najmeh Hejazi
Department of Nutrition and Food Science, Fatholmobin alley, Razi blvd
Shiraz Iran (Islamic Republic of) 7153675541 +98 71 3725 1007 Najmehhejazi@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Men and women aged 65 years and older Sarcopenia diagnosis according to European Working Group on Sarcopenia in Older People (EWGSOP) guidelines using calcium and vitamin D supplements 65 years no limit Both Subjects with history of chronic disease (e.g. Congestive Heart Failure (CHF), Chronic Obstructive Pulmonary Disorder (COPD), Chronic Renal Failure (CRF), cirrhosis liver failure and active cancer. Subjects with history of uncontrolled diabetes and stroke. M62.84 Sarcopenia Rehabilitation Placebo Intervention group: Receiving egg white protein (Gol Powder Golestan Co, Iran) and zinc (Zahravi Pharm Co, Iran)-enriched synbiotic (Pardis Roshd Mehregan Co, Iran) powder daily for 8 weeks Control group: Receiving Placebo powder (Pardis Roshd Mehregan Co, Iran) daily for 8 weeks Hand grip Strength. Timepoint: Baseline and End-of-trial. Method of measurement: Hydraulic Hand Dynamometer. Lean body mass. Timepoint: Baseline and End-of-trial. Method of measurement: Dual energy X-ray Absorptiometry (DXA). Appendicular Skeletal Muscle Mass. Timepoint: Baseline and End-of-trial. Method of measurement: Dual energy X-ray Absorptiometry (DXA). Weight. Timepoint: Baseline and End-of-trial. Method of measurement: Standardized methods. BMI. Timepoint: Baseline and End-of-trial. Method of measurement: Standardized methods. Waist circumference. Timepoint: Baseline and End-of-trial. Method of measurement: Standardized methods. Calf circumference. Timepoint: Baseline and End-of-trial. Method of measurement: Standardized methods. Arm circumference. Timepoint: Baseline and End-of-trial. Method of measurement: Standardized methods. Fat mass. Timepoint: Baseline and End-of-trial. Method of measurement: Dual energy X-ray Absorptiometry (DXA). Gynoid fat mass. Timepoint: Baseline and End-of-trial. Method of measurement: Dual energy X-ray Absorptiometry (DXA). Android fat mass. Timepoint: Baseline and End-of-trial. Method of measurement: Dual energy X-ray Absorptiometry (DXA). Physical performance. Timepoint: Baseline and End-of-trial. Method of measurement: The Short Physical Performance Battery (SPPB) score. Quality of life. Timepoint: Baseline and End-of-trial. Method of measurement: The Short Form Health Survey-36 (SF-36) questionnaire and sarcopenia specific quality of life questionnaire (SarQoL®-IR). Percent of fat. Timepoint: Baseline and End-of-trial. Method of measurement: Dual energy X-ray Absorptiometry (DXA). Fasting Blood Sugar (FBS) level. Timepoint: Baseline and End-of-trial. Method of measurement: Auto analyser. Lipid profile (LDL, HDL, Triglyceride, total cholesterol). Timepoint: Baseline and End-of-trial. Method of measurement: Chemical method (kit). Shiraz University of Medical Sciences Approved 2021-03-10 Ethics Committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences, Zand street Shiraz Fars Iran (Islamic Republic of)