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IRCT20090822002365N30 IRCT 2024-06-22 Iran University of Medical Sciences Effect of magnesium and omega 3 co-supplementation supplement in Sarcopenic Elderly The effect of magnesium and omega 3 co-supplementation on muscle strength, physical performance, muscle mass, inflammation, and intrinsic capacity index in elderly with sarcopenia: A double-blind randomized placebo-control trial 2024-07-22 anticipated 66 Complete https://irct.ir/trial/77363 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Allocating samples to intervention and placebo groups will be done using the block method with blocks 4 and 6, Blinding description: To hide the random allocation, unique codes will be used on the supplement cans and the desired code will be generated by the software and will be done by the sealed envelope method with a random sequence. Allocation is done by someone who is outside the study. As each person enters the study based on the generated sequence, the supplementary package in which the desired code is recorded will be assigned to the person, and therefore, before choosing the person, no one will be aware of the type of treatment he will receive. Also, the person evaluating the patient will not be aware of the intervention. 3 Condition 1: Sarcopenia. Condition 2: Intrinsic capacity. Intervention 1: Intervention group: 33 elderly receive one tablet of 250 mg of magnesium supplement and 1000 mg of omega 3(120 mg EPA and 180 mg DHA) daily for 8 weeks each. Intervention 2: Control group: 33 elderly, each receiving 1 placebo magnesium tablet and 1 placebo omega 3 capsule 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: Department of nutrition, school of health, Iran university of medical sciences, Hemmat highway, Tehran. Phone number: 0098 21 86704743. E-mail: vafa.m@iums.ac.ir How to obtain: Applicants can be contacted with corresponding author by e-mail or postal address to receive the requested data. Postal address: Department of nutrition, school of health, Iran university of medical sciences, Hemmat highway, Tehran. Phone number: 0098 21 86704743. E-mail: vafa.m@iums.ac.ir 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 4743 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 4743 vafa.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Complete and sign informed consent Age 60-84 years Diagnosis of possible sarcopenia according to update of Asian Working Group for Sarcopenia (AWGS) (hand grip strength less than 28 kg in men and less than 18 kg in women) Impaired intrinsic capacity according to the first step of ICOPE guidelines of the World Health Organization Required no or some support with self-care (feeding, bathing, dressing, toileting). Taking any supplements containing magnesium and omega-3 during the last 2 months Taking any supplements containing more than 100 mg magnesium 60 years 84 years Both Acute cardiovascular diseases, acute infection, and acute cerebrovascular disease Severe cardiac, liver, kidney dysfunction, autoimmune Uncontrolled diabetes Dementia, Parkinsons disease, and mental illnesses unable to provide informed consent because of aphasia, deafness, and blindness Physically-handicapped, disability, and use of a wheelchair or walker Taking hormonal drugs smoking Acute illness (cold, corona and any other viral-bacterial-fungal disease) Taking steroidal and non-steroidal anti-inflammatory drugs, aminoglycoside antibiotics, laxatives and laxatives M62.5 Muscle wasting and atrophy, not elsewhere classified Treatment - Other Placebo Intervention group: 33 elderly receive one tablet of 250 mg of magnesium supplement and 1000 mg of omega 3(120 mg EPA and 180 mg DHA) daily for 8 weeks each. Control group: 33 elderly, each receiving 1 placebo magnesium tablet and 1 placebo omega 3 capsule daily for 8 weeks. Muscle strength. Timepoint: At the baseline and after 8 weeks of intervention. Method of measurement: Handgrip strength. Muscle function. Timepoint: At the baseline and after 8 weeks of intervention. Method of measurement: Short Physical Performance Battery (SPPB). Muscle mass. Timepoint: At the baseline and after 8 weeks of intervention. Method of measurement: Bioelectrical Impedance Analysis (BIA). Inflammation. Timepoint: At the baseline and after 8 weeks of intervention. Method of measurement: The level of CRP and ESR in serum. Intrinsic capacity index. Timepoint: At the baseline and after 8 weeks of intervention. Method of measurement: Short Physical Performance Battery (SPPB), Mini-mental state examination(MMSE), Patient Health Questionnaire-9(PHQ-9), WHISPER test, WHO simple eye chart, Mini nutritional assessment (MNA). Frailty. Timepoint: At the baseline and after 8 weeks of intervention. Method of measurement: The Fried phenotype (FP). Iran University of Medical Sciences Approved 2024-06-02 Ethics Committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran Tehran Tehran Iran (Islamic Republic of)