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IRCT20250317065109N1 IRCT 2025-04-02 Shiraz University of Medical Sciences Comparison of the effect of magnesium and synbiotic supplementation on cognitive function, quality of life, frailty and inflammation Comparison of the effect of magnesium and synbiotic supplementation on cognitive function, quality of life, frailty and serum level of the inflammatory index high-sensitivity C - reactive protein in the older adults with mild cognitive impairment 2025-04-21 anticipated 63 Complete https://irct.ir/trial/82605 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants will be randomly assigned to three groups: magnesium intervention, synbiotic intervention, and control (A, B, C) based on the random blocking method using the Random Allocation Software with a ratio of 1:1:1. This group assignment will be done by a person outside the study before the start of the design implementation process, and these sequences will be placed in sealed numbered envelopes by the same person in order to blind the researchers to the participant group by concealing the allocation. After screening with a cognitive function assessment questionnaire and confirmation of mild cognitive impairment, participants will be referred to the research team and the thesis supervisor. After completing the evaluations and the initial questionnaires, an envelope will be opened according to the established order, and the assigned intervention group will be determined for the participating individual. This randomization and groups will remain hidden from the researchers and participants until the statistical analysis are complete, Blinding description: In the first phase of the study, the supplements and placebo are placed in capsules that are similar in color, size, and shape and packaged. In this phase, the capsules are labeled with the Latin contract names A, B, and C. In the intervention phase, the random assignment sequence is also identified with the same names by a person outside the study. Therefore, during the study, the participants and the student implementing the project, who is in charge of carrying out the clinical phase, clinical evaluations, follow-up of laboratory tests and data analysis, will be blinded to the assigned group and the intervention in each group. N/A Mild cognitive impairment. Intervention 1: First intervention group: In this group, individuals will receive one capsule containing 300 mg of elemental magnesium (500 mg of magnesium in the form of magnesium oxide) daily for 8 weeks. Magnesium supplements will be prepared from Jalinous Pharmaceutical Company in the form of magnesium oxide powder and encapsulated by Shiraz Faculty of Pharmacy. Intervention 2: Second intervention group: In this group, individuals will receive one synbiotic capsule daily for 8 weeks. The synbiotic supplement will be provided in capsule form by the Zist Takhmir Pharmaceutical Company (Familact®). This supplement contains 109 CFU of probiotics including Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus acidophilus, Lactobacillus casei, Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium lactis, Bifidobacterium bifidum, Streptococcus thermophilus, and 74 mg of fructooligosaccharide in synbiotic form. Intervention 3: Control group: In this group, individuals will receive a placebo in capsule form that is similar in appearance to the intervention group for 8 weeks. Also, the placebo will be provided in capsule form by Zist Takhmir Pharmaceutical Company. The content of the placebo will be mostly maltodextrin and lactose monohydrate. 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 No more information available.
public Rahil Ranjbar
Alley 19, Yas street, Ayatollah Nassabeh Town, Darab
Darab Iran (Islamic Republic of) 7481315134 +98 71 5357 9434 Rahilranjbar9@gmail.com Shiraz University of Medical Sciences scientific Afsane Ahmadi
School of Nutrition and Food Sciences, in front of Bargh Sports Club, Razi Blvd, Shiraz
Shiraz Iran (Islamic Republic of) 7153675500 +98 71 3725 1001 -8 ahmadi.afsane@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Age 65 years and older Suffering from mild cognitive impairment; means obtaining a score of 22 to 25 in the Mini-ACE cognitive function evaluation form Ability and willingness to participate in the study No smoking/alcohol and drug addiction Absence of severe renal/hepatic/pulmonary insufficiency, uncontrolled diabetes, severe neurological or psychiatric disorders such as Bipolar disorder, Parkinson's disease, Dementia, unstable thyroid disease; Immune disorders such as HIV/AIDS Not following specific diets (such as Ketogenic, Vegetarian, etc.) No current use of medications that interact with magnesium, such as muscle relaxants, Penicillamine, Corticosteroids, Methyldopa, Magnesium-containing antacids, or other magnesium-containing products Participants must have not taken antibiotics and probiotic, magnesium, and antioxidant supplements for at least 2 weeks prior to the start of the study 65 years no limit Both Changes in usual diet and medication Starting antibiotic therapy The occurrence of any side effects that stops when the intervention is discontinued. Less than 80% adherence to supplement use Unwillingness to continue cooperation G31.84 Mild cognitive impairment, so stated Treatment - Other Treatment - Other Placebo First intervention group: In this group, individuals will receive one capsule containing 300 mg of elemental magnesium (500 mg of magnesium in the form of magnesium oxide) daily for 8 weeks. Magnesium supplements will be prepared from Jalinous Pharmaceutical Company in the form of magnesium oxide powder and encapsulated by Shiraz Faculty of Pharmacy. Second intervention group: In this group, individuals will receive one synbiotic capsule daily for 8 weeks. The synbiotic supplement will be provided in capsule form by the Zist Takhmir Pharmaceutical Company (Familact®). This supplement contains 109 CFU of probiotics including Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus acidophilus, Lactobacillus casei, Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium lactis, Bifidobacterium bifidum, Streptococcus thermophilus, and 74 mg of fructooligosaccharide in synbiotic form. Control group: In this group, individuals will receive a placebo in capsule form that is similar in appearance to the intervention group for 8 weeks. Also, the placebo will be provided in capsule form by Zist Takhmir Pharmaceutical Company. The content of the placebo will be mostly maltodextrin and lactose monohydrate. Cognitive function score in the Mini-Addenbrooke’s Cognitive Examination (M-ACE) questionnaire. Timepoint: Cognitive function assessment before the start of the intervention and 8 weeks later (end of the study). Method of measurement: Mini-Addenbrooke’s Cognitive Examination (M-ACE) questionnaire. Serum level of high-sensitivity C-reactive protein. Timepoint: Measurement of serum levels of high-sensitivity C-reactive protein before the start of the intervention and 8 weeks later (end of study). Method of measurement: Through a blood test and ELISA method. Quality of life score in the Older People's Quality of Life questionnaire (OPQOL-brief). Timepoint: Quality of life assessment before the start of the intervention and 8 weeks later (end of the study). Method of measurement: Older People's Quality of Life questionnaire-brief version (OPQOL-brief). Frailty score in the Frailty Syndrome Checklist 5-Items in Frail Older Adults in Iran (Fried's Five-Point Frailty Test). Timepoint: Frailty assessment before the start of the intervention and 8 weeks later (end of the study). Method of measurement: Frailty score in the Frailty Syndrome Checklist 5-Items in Frail Older Adults in Iran (Fried's Five-Point Frailty Test). Shiraz University of Medical Sciences Approved 2025-02-16 Ethics committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences Central Building, in front of Palestine, Zand Street Shiraz Fars Iran (Islamic Republic of)