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IRCT20260821070744N1 IRCT 2026-09-05 Islamic Azad University, Ahvaz Effects of Combined Training and Leucine-Enriched Whey Protein on MyomiRs and Muscle Function in Older Adults The Effect of Combined Aerobic–Resistance Training with Leucine-Enriched Whey Protein Supplementation on Muscle-Derived Exosomal microRNAs and Muscle Functional Indices in Older Adults Aged 60–70 Years 2026-04-09 anticipated 40 Complete https://irct.ir/trial/92802 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, a quasi-randomized method based on alternating allocation based on the order of referral was used. Participants were randomly assigned to four groups (exercise, supplement, exercise + supplement, and control) in the order of study entry. The randomization unit was individual and stratification was not used due to the homogeneity of the participants. To conceal allocation, the allocation sequence was kept in opaque, numbered envelopes by someone independent of the researcher, Blinding description: This study was designed as a single-blind study. Given the open-label nature of the exercise interventions and supplement use, blinding of participants and exercise trainers was not possible, and participants were aware of their intervention group. However, the outcome assessors and data analysts were kept completely blind to the group allocation of participants. All anthropometric measurements, muscle performance indices, and Real-Time PCR tests were performed by independent, trained assessors who were unaware of the grouping of participants. Blood samples and performance data were sent to the laboratory and statistical analyst with only specific codes (without mentioning the participant's name or group). The data analyst was also informed of the data grouping after the statistical analyses were completed and the final results were extracted. The principal investigator was unaware of the group allocation of participants until the intervention was completed and data were collected. This method minimised detection and analysis bias in accordance with the CONSORT 2010 statement and IRCT guidelines. 1 Elderly. Intervention group: Control Group:Participants in the control group will not receive any regular exercise program (aerobic, resistance, or combined) during the 8-week study period and will not take any whey protein supplements or other nutritional supplements. These individuals are asked to maintain their usual lifestyle and refrain from starting any new exercise programs or taking new supplements during the study period. After the study period and final measurements are completed, in order to comply with research ethics, the same exercise program as the intervention groups will be provided to the control group individuals.Intervention Group One (Combined Exercise Group):Participants in this group will participate in a combined aerobic-resistance exercise program, 3 sessions per week (Sunday, Tuesday, and Thursday) for 8 weeks. Each workout lasts 60 to 75 minutes and consists of three main parts:Warm-up (10 minutes): Includes 5 minutes of light-intensity aerobic activity (stationary bike or treadmill walking at a Borg intensity of 3 to 4) and 5 minutes of dynamic stretching.Main workout (50 minutes): Includes two separate parts:Resistance training (25 to 30 minutes): Includes 8 multi-joint movements for the major muscle groups (chest, shoulders, back, arms, thighs, and abs) including: dumbbell bench press, dumbbell shoulder press, lat pull-up (with resistance band), dumbbell biceps curl, dumbbell biceps curl, bodyweight squat, lunge, and plank. Workout intensity is determined based on percentage of one repetition maximum (1RM) and gradually increases from 50-60% of 1RM in the first and second weeks to 75-80% of 1RM in the seventh and eighth weeks. Each exercise is performed in 3 sets, each set consisting of 10 to 12 repetitions. Rest time between sets is 60 to 90 seconds and between exercises is 90 to 120 seconds.Aerobic exercise (20 to 25 minutes): Performed on a treadmill. Exercise intensity is determined based on the percentage of maximum heart rate reserve (HRR) using the Karonen formula and increases from 50-60% HRR in weeks 1 to 4 to 60-70% HRR in weeks 5 to 8. Aerobic exercise duration also increases from 20 minutes in week 1 to 25 minutes in week 8. Heart rate is monitored during sessions using a chest heart rate sensor (Polar).Cool down (10 minutes): Includes 5 minutes of very light walking and 5 minutes of static stretching for the main muscles involved.Intervention group 2 (leucine-enriched whey protein supplement group):Participants in this group received one serving of leucine-enriched whey protein supplement branded FortiFit® (ActiSyn™) (manufactured by Nutricia, Netherlands/France) daily for 8 weeks. Each serving of the supplement contained 20 g of whey protein powder, equivalent to 21 g of protein and containing 3 g of leucine and 800 IU of vitamin D. This supplement was dissolved in 200 to 300 ml of water and consumed on non-training days, on an empty stomach or between meals. Participants in this group did not receive any training program.Intervention group 3 (combined exercise + supplement group):Participants in this group received both of the above interventions simultaneously:1. Combined aerobic-resistance training program for 8 weeks, 3 sessions per week (according to the full description of the first intervention group).2. Leucine-rich whey protein supplement for 8 weeks, one serving daily (as per the full description of the second intervention group). On training days, the supplement is consumed up to 30 minutes after the end of the training session, and on non-training days, it is consumed on an empty stomach or between meals.. Yes - There is a plan to make this available What will be shared: General information and result are presentein the text of the thesis and article When: 6 months after the student's defense To whom: The data will be published in the form of research findings and will be available for everyone to use Conditions: The use of the results is permitted provided that the source is properly cited. Where to obtain: The journal or journals in which the results will be published How to obtain: The process of publishing the article in journals Comments: 0
public Navid noroozi
Farhang shahr
Ahvaz Iran (Islamic Republic of) 373333-61349 +98 61 3446 0302 Naviddivan71@gmail.com Islamic Azad University scientific Ahmad kaki
Farhang shahr
Ahvaz Iran (Islamic Republic of) 373333-61349 373333-61349 Naviddivan71@gmail.com Islamic Azad University Iran (Islamic Republic of) 1. Age range 60-70 years2. Not participating in regular exercise programs (at least two sessions per week) in the past six months3. Score above 21 on the Mini-Mental State Examination4. Ability to walk independently without assistance or assistive devices5. Obtaining approval from a physician to participate in the exercise program6. Signing a written informed consent form 60 years 70 years Male 1. Absence of more than two consecutive training sessions or more than 20% of all training sessions during the study period2. Acute illness or exacerbation of chronic illness during the study period3. Starting to take drugs that affect muscle mass (such as corticosteroids, anabolic steroids, growth hormone) during the study4. Personal desire to withdraw from the study5. Hospitalization for any reason during the study period6. Occurrence of any musculoskeletal injury caused by training that prevents continuation of training7. Significant decline in cognitive status (decrease of more than 3 points in MMSE or score below 21) Z00.0 Encounter for general adult medical examination Prevention Intervention group: Control Group:Participants in the control group will not receive any regular exercise program (aerobic, resistance, or combined) during the 8-week study period and will not take any whey protein supplements or other nutritional supplements. These individuals are asked to maintain their usual lifestyle and refrain from starting any new exercise programs or taking new supplements during the study period. After the study period and final measurements are completed, in order to comply with research ethics, the same exercise program as the intervention groups will be provided to the control group individuals.Intervention Group One (Combined Exercise Group):Participants in this group will participate in a combined aerobic-resistance exercise program, 3 sessions per week (Sunday, Tuesday, and Thursday) for 8 weeks. Each workout lasts 60 to 75 minutes and consists of three main parts:Warm-up (10 minutes): Includes 5 minutes of light-intensity aerobic activity (stationary bike or treadmill walking at a Borg intensity of 3 to 4) and 5 minutes of dynamic stretching.Main workout (50 minutes): Includes two separate parts:Resistance training (25 to 30 minutes): Includes 8 multi-joint movements for the major muscle groups (chest, shoulders, back, arms, thighs, and abs) including: dumbbell bench press, dumbbell shoulder press, lat pull-up (with resistance band), dumbbell biceps curl, dumbbell biceps curl, bodyweight squat, lunge, and plank. Workout intensity is determined based on percentage of one repetition maximum (1RM) and gradually increases from 50-60% of 1RM in the first and second weeks to 75-80% of 1RM in the seventh and eighth weeks. Each exercise is performed in 3 sets, each set consisting of 10 to 12 repetitions. Rest time between sets is 60 to 90 seconds and between exercises is 90 to 120 seconds.Aerobic exercise (20 to 25 minutes): Performed on a treadmill. Exercise intensity is determined based on the percentage of maximum heart rate reserve (HRR) using the Karonen formula and increases from 50-60% HRR in weeks 1 to 4 to 60-70% HRR in weeks 5 to 8. Aerobic exercise duration also increases from 20 minutes in week 1 to 25 minutes in week 8. Heart rate is monitored during sessions using a chest heart rate sensor (Polar).Cool down (10 minutes): Includes 5 minutes of very light walking and 5 minutes of static stretching for the main muscles involved.Intervention group 2 (leucine-enriched whey protein supplement group):Participants in this group received one serving of leucine-enriched whey protein supplement branded FortiFit® (ActiSyn™) (manufactured by Nutricia, Netherlands/France) daily for 8 weeks. Each serving of the supplement contained 20 g of whey protein powder, equivalent to 21 g of protein and containing 3 g of leucine and 800 IU of vitamin D. This supplement was dissolved in 200 to 300 ml of water and consumed on non-training days, on an empty stomach or between meals. Participants in this group did not receive any training program.Intervention group 3 (combined exercise + supplement group):Participants in this group received both of the above interventions simultaneously:1. Combined aerobic-resistance training program for 8 weeks, 3 sessions per week (according to the full description of the first intervention group).2. Leucine-rich whey protein supplement for 8 weeks, one serving daily (as per the full description of the second intervention group). On training days, the supplement is consumed up to 30 minutes after the end of the training session, and on non-training days, it is consumed on an empty stomach or between meals. Row Title Variable Type Measurement Time1 Relative expression of primary miR-1 before and 48 hours after intervention2 Relative expression of primary miR-133a before and 48 hours after intervention3 Relative expression of primary miR-206 before and 48 hours after intervention4 Secondary grip strength before and 48 hours after intervention5 Secondary sit-to-stand 30 seconds before and 48 hours after intervention6 Secondary TUG test before and 48 hours after intervention7 Secondary Myostatin/IGF-1 ratio before and 48 hours after intervention. Timepoint: Time Period Description Time IntervalPretest One week before the start of the intervention Week 0Posttest 48 hours after the last training session (end of week 8) Week 8. Method of measurement: Row Title Variable Measurement Instrument1 Relative expression of miR-1 Real-Time PCR with ABI Step One Plus, normalized with U6 snRNA2 Relative expression of miR-133a Real-Time PCR with ABI Step One Plus, normalized with U6 snRNA3 Relative expression of miR-206 Real-Time PCR with ABI Step One Plus, normalized with U6 snRNA4 Grip strength Takei digital handheld dynamometer, Japan5 30-second sit-to-stand test Standard chair (height 43 cm) and digital stopwatch6 TUG test Digital stopwatch, distance 3 m. Islamic azad university Approved 2026-03-05 کمیته اخلاق در پژوهش دانشگاه آزاد اسلامی واحد اهواز Ahvaz Branch, Islamic Azad University, Ahvaz, Iran Address: Ahvaz - Golestan Highway, Farhangshahr, Islamic Azad University, Ahvaz Branch - Department of Sports Physiology Postal Code 373333-61349 PO Box 1915 ahvaz Khouzestan Iran (Islamic Republic of)