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IRCT20090901002394N43 IRCT 2019-06-13 Iran University of Medical Sciences Effect of isowhey and omega-3 fatty acids on mobility, muscle strength in prefrail older adult Effect of isowhey supplementation alone, or in combination with omega-3 fatty acids, on mobility, muscle strength and cognitive state in prefrail older adults 2019-06-22 anticipated 90 Complete https://irct.ir/trial/38772 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: For random allocation of individuals to the three groups, the permuted block randomization method will be applied, using a computer program, and the length of blocks will be considered randomly as 3, 6 or 9, Blinding description: Blinding: Placebo and supplements are similar in appearance and coded by someone other than the researcher. All investigators, study staff, and participants will be unaware of the allocations. When the statistical model of the primary and secondary results is not complete, the randomization code will not be broken. 3 Frailty syndrome. Intervention 1: Intervention group 1: Daily intake of 20 gr isowhey and omega-3 placebo for 12 weeks. Intervention 2: Intervention group 2: Daily intake of 20 gr isowhey and two omega-3 fatty acids capsules for 12 weeks. Intervention 3: Control group: Placebos with same characteristics for 4 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 more information.
public Dr Shima Jazayeri
Iran University of Medical Sciences,Hemmat Highway,Tehran, Iran
Tehran Iran (Islamic Republic of) 1449614535 +98 86704805 Jazayeri.sh@iums.ac.ir Iran University of Medical Sciences scientific Dr Shima Jazayeri
Iran University of Medical Sciences,Hemmat Highway,Tehran, Iran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4805 Jazayeri.sh@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Community dwelling older adults Man or woman aged 60 years or older Meet one or two CHS frailty criteria: 1 - Weight loss 2 - Weakness 3 - Exhaustion 4 - Slowness of movement 5 - Low physical activity 60 years no limit Both Taking any steroids Taking anticoagulant drugs Regular consumption of omega-3 fatty acid supplements over the 3 months prior to study (more than twice a week) Critical illnesses including kidney failure, liver, heart disease, or chronic pulmonary failure, diabetes, malignancy (over the past 5 years) A history of exercises during the past two years (more than twice a week) Regular use of food supplements (more than twice a week) other than calcium and vitamin B12 Smoking and alcohol consumption Use of mobility devices (wheelchairs, cane ...) severe cognitive problems R54 Age-related physical debility Prevention Prevention Placebo Intervention group 1: Daily intake of 20 gr isowhey and omega-3 placebo for 12 weeks Intervention group 2: Daily intake of 20 gr isowhey and two omega-3 fatty acids capsules for 12 weeks Control group: Placebos with same characteristics for 4 weeks Muscle strength (Handgrip Strength):Muscle strength will assess by handgrip Strength,The difference in the rate of these outcomes changes between the intervention and placebo groups will be determined. Timepoint: At the beginning, and at the end of weeks 6 and 12 hand grip strength will be implemented. Method of measurement: Muscle strength will assess by hand grip Strength. Measured using a dynamometer device. Mini Nutritional Assessment (MNA): assessment of the nutritional status is conducted with a brief nutritional assessment. The difference in the rate of change between the intervention and placebo groups will be determined. Timepoint: Participants in the study will be evaluated at the beginning and end of the intervention(at the end of 12 week intervention). Method of measurement: Nutritional status will assess with MNA(mini nutritional assessment) questionnaire. Physical performance: The difference in the rate of change between the intervention and placebo groups will be determined. Timepoint: At the beginning, and at the end of weeks 6 and 12 hand grip strength will be implemented. Method of measurement: It will be run using a clinical test (TUG; Time Up and GO) and will be performed by evaluator. Gait Speed: The difference in the rate of change between interventional and placebo groups will be determined. Timepoint: At the beginning, and at the end of weeks 6 and 12 hand grip strength will be implemented. Method of measurement: It will be run using a clinical test and will be performed by evaluator. Cognitive status : In order to assess the cognitive status of elderly people participating in the intervention, they will be evaluated. The difference in the rate of these outcomes changes between the intervention and placebo groups will be determined. Timepoint: Participants in the study will be evaluated at the beginning and end of the intervention(at the end of 12 week intervention). Method of measurement: Cognitive function will assess by cognitive examination. Stroop وDSB(Digit Span Backward). CRP(C-Reactive Protein). Timepoint: Participants in the study will be evaluated at the beginning and end of the intervention(at the end of 12 week intervention). Method of measurement: Turbidimetric test. BDNF(Brain-derived neurotrophic factor). Timepoint: Participants in the study will be evaluated at the beginning and end of the intervention(at the end of 12 week intervention). Method of measurement: ELISA. University of social welfare and rehabilitation sciences Iran University of Medical Sciences University of social welfare and rehabilitation sciences Approved 2017-10-14 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Besides Milad Tower, Hemmat, Tehran Tehran Tehran Iran (Islamic Republic of)