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

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

A clinical trial with control group, double-blind, randomized, parallel-group on 63 participants. Random Allocation Software was used for randomization.

Participants will be selected by a simple random sampling from ّFarzanegan senior senter in Shiraz; after screening and confirming the disease and if they meet the study entry criteria, the informed consent form will be completed. Participants will be placed in one of three groups: magnesium intervention, synbiotic, and placebo by a random block method. outcomes will be evaluated at the beginning and end of the study. The duration of the intervention is 8 weeks. Also, in this study, participants and the researcher will be blinded.

Inclusion criteria included: age 65 years and older, mild cognitive impairment, no severe renal/liver/pulmonary insufficiency, no uncontrolled diabetes, no severe neurological or psychiatric disorders, no adherence to special diets, no current use of medications that interact with magnesium. Exclusion criteria included changes in usual diet and medication, initiation of antibiotic therapy, occurrence of any side effects that stopped with discontinuation of the intervention, adherence of less than 80% and unwillingness to continue cooperation.

Eligible people are placed in one of the following groups by random blocking method: group1: taking a capsule containing 300 mg of elemental magnesium daily. Group 2: taking a synbiotic capsule daily. Group 3: taking a placebo

Cognitive function, quality of life, frailty, serum level of the inflammatory index hs-CRP

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.

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.