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IRCT20251112067968N2 IRCT 2026-04-01 Islamic Azad University Resistance Training, Nano-Curcumin and Insomnia Effects of Evening Resistance Training and Nano-Curcumin on Insomnia Severity and Neuroendocrine–Inflammatory Biomarkers 2025-04-04 anticipated 80 Complete https://irct.ir/trial/89086 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: Following completion of baseline assessments, participants were randomly assigned in a 1:1:1:1 ratio to one of four parallel groups: (1) resistance training plus nano‑curcumin (RT+NC), (2) resistance training plus placebo (RT+PL), (3) nano‑curcumin only (NC), and (4) placebo control (PL). The randomization sequence was generated using computer‑generated random numbers (Random.org). Permuted block randomization with fixed block size of four was applied to maintain balanced group sizes throughout recruitment. Within each block, all four possible assignments were randomly ordered, and the blocks were then concatenated to create the final sequence. An independent researcher not involved in enrollment or outcome assessment created and safeguarded the sequence. Allocation concealment was maintained using sequentially numbered, opaque, sealed envelopes (SNOSE). Each envelope was opened only after a participant was fully enrolled, by a staff member who had no access to the sequence. Supplement allocation was performed under double‑blind conditions. Nano‑curcumin and placebo capsules were identical in appearance, including size, color, weight, and packaging. Participants, laboratory personnel, and outcome assessors remained blinded to supplementation assignment throughout the study. Due to the nature of the intervention, blinding to resistance‑training allocation was not feasible; however, outcome assessment and data analysis were conducted by personnel blinded to group assignments, Blinding description: Supplement allocation was double-blinded. Nano-curcumin and placebo capsules were identical in size, color, weight, and packaging to ensure masking. Participants were blinded to supplementation assignment throughout the study. Laboratory personnel responsible for biomarker analyses and outcome assessors were also blinded to supplementation allocation. Data analysis was performed by personnel who were unaware of group assignments. Due to the nature of the intervention, blinding to resistance training allocation was not feasible. No Data Safety and Monitoring Committee was reported. 3 Insomnia Disorder. Intervention 1: Intervention group 1: Evening resistance training plus nano-curcumin supplementation. Resistance training perform three sessions per week for 12 weeks that were conducted between 17:00 and 19:00. Each session included a 5–10-minute warm-up followed by six exercises that include back squat, Romanian deadlift, bench press, seated row, shoulder press, and abdominal plank hold. Training intensity is 60% 1RM in weeks one to three ; 65% 1RM in weeks four to six; 70% 1RM in weeks seven to ninth; and 75% 1RM in weeks ten to twelve. Each resistance session include 3 sets with 8-12 repetition with 90-120 seconds rest intervals. Also, participants consume nano-curcumin (Exir Nano Sina Company, Iran): 40 mg twice daily (80 mg in total) in morning (after breakfast) and evening (one hour before habitual bedtime) for 12 weeks. Intervention 2: Intervention group 2: Combined evening resistance training plus placebo supplementation. Resistance training perform three sessions per week for 12 weeks that were conducted between 17:00 and 19:00. Each session included a 5–10-minute warm-up followed by six exercises that include back squat, Romanian deadlift, bench press, seated row, shoulder press, and abdominal plank hold. Training intensity is 60% 1RM in weeks one to three ; 65% 1RM in weeks four to six; 70% 1RM in weeks seven to ninth; and 75% 1RM in weeks ten to twelve. Each resistance session include 3 sets with 8-12 repetition with 90-120 seconds rest intervals. Also, participants consume capsules contained inert microcrystalline cellulose (Barij Essence Pharmaceutical Company, Kashan, Iran) that were identical in appearance and packaging to active capsules; taken twice daily (morning and evening) for 12 weeks. Intervention 3: Intervention group 3: Nano-curcumin supplementation without resistance training. participants consume nano-curcumin (Exir Nano Sina Company, Iran): 40 mg twice daily (80 mg in total) in morning (after breakfast) and evening (one hour before habitual bedtime) for 12 weeks. Intervention 4: Control group: Placebo supplementation without resistance training. Participants consume capsules contained inert microcrystalline cellulose (Barij Essence Pharmaceutical Company, Kashan, Iran) that were identical in appearance and packaging to active capsules; taken twice daily (morning and evening) for 12 weeks. Yes - There is a plan to make this available What will be shared: All data without participant names When: 6 months after publication of the article To whom: University students and professors Conditions: For future research Where to obtain: To the researchers of this study How to obtain: By email to researchers Comments:
public Akram Jafari
Islamic Azad University Shahrekord Branch, Rahmatieh, Shahrekord, Iran
Shahrekord Iran (Islamic Republic of) 8818630003 +98 38 3336 1001 jafari.akm@gmail.com Islamic Azad University scientific Akram Jafari
Islamic Azad University Shahrekord Branch, Rahmatieh, Shahrekord, Iran
Shahrekord Iran (Islamic Republic of) 8818630003 +98 38 3336 1001 Jafari.akm@gmail.com Islamic Azad University Iran (Islamic Republic of) Male university students aged 18–25 years Insomnia Severity Index score ≥ 10 Pittsburgh Sleep Quality Index global score ≥ 5 Clinician-confirmed diagnosis of Insomnia Disorder according to DSM-5 criteria with difficulty initiating sleep, difficulty maintaining sleep, and/or early morning awakening occurring ≥ 3 nights per week for ≥ 3 months Presence of clinically meaningful daytime impairment including fatigue, mood disturbance, or cognitive or academic dysfunction No participation in structured resistance training within the previous 6 months Maintenance of regular daytime schedules and stable living conditions during the study period 18 years 25 years Male Physician-diagnosed sleep disorders other than insomnia including obstructive sleep apnea or restless legs syndrome High risk of obstructive sleep apnea based on STOP-Bang questionnaire Shift work within the previous 3 months Current smoking Alcohol intake greater than 2 standard drinks per week Chronic inflammatory, endocrine, cardiovascular, metabolic, or neurological disease Use of hypnotics, antidepressants, corticosteroids, anti-inflammatory medications, or dietary supplements known to affect sleep or inflammatory status within the prior 3 months F51 Sleep disorders not due to a substance or known physiological condition N/A N/A N/A N/A Intervention group 1: Evening resistance training plus nano-curcumin supplementation. Resistance training perform three sessions per week for 12 weeks that were conducted between 17:00 and 19:00. Each session included a 5–10-minute warm-up followed by six exercises that include back squat, Romanian deadlift, bench press, seated row, shoulder press, and abdominal plank hold. Training intensity is 60% 1RM in weeks one to three ; 65% 1RM in weeks four to six; 70% 1RM in weeks seven to ninth; and 75% 1RM in weeks ten to twelve. Each resistance session include 3 sets with 8-12 repetition with 90-120 seconds rest intervals. Also, participants consume nano-curcumin (Exir Nano Sina Company, Iran): 40 mg twice daily (80 mg in total) in morning (after breakfast) and evening (one hour before habitual bedtime) for 12 weeks. Intervention group 2: Combined evening resistance training plus placebo supplementation. Resistance training perform three sessions per week for 12 weeks that were conducted between 17:00 and 19:00. Each session included a 5–10-minute warm-up followed by six exercises that include back squat, Romanian deadlift, bench press, seated row, shoulder press, and abdominal plank hold. Training intensity is 60% 1RM in weeks one to three ; 65% 1RM in weeks four to six; 70% 1RM in weeks seven to ninth; and 75% 1RM in weeks ten to twelve. Each resistance session include 3 sets with 8-12 repetition with 90-120 seconds rest intervals. Also, participants consume capsules contained inert microcrystalline cellulose (Barij Essence Pharmaceutical Company, Kashan, Iran) that were identical in appearance and packaging to active capsules; taken twice daily (morning and evening) for 12 weeks. Intervention group 3: Nano-curcumin supplementation without resistance training. participants consume nano-curcumin (Exir Nano Sina Company, Iran): 40 mg twice daily (80 mg in total) in morning (after breakfast) and evening (one hour before habitual bedtime) for 12 weeks. Control group: Placebo supplementation without resistance training. Participants consume capsules contained inert microcrystalline cellulose (Barij Essence Pharmaceutical Company, Kashan, Iran) that were identical in appearance and packaging to active capsules; taken twice daily (morning and evening) for 12 weeks. Total score of insomnia severity index. Timepoint: At baseline before randomization and at week12 after completion of the intervention. Method of measurement: Insomnia Severity Index questionnaire. Total sleep time. Timepoint: Before intervention and after completing 12 weeks of intervention. Method of measurement: Consensus Sleep Diary core version. Wake after sleep onset. Timepoint: Before intervention and after completing 12 weeks of intervention. Method of measurement: Consensus Sleep Diary core version. Sleep efficiency. Timepoint: Before intervention and after completing 12 weeks of intervention. Method of measurement: Consensus Sleep Diary core version. Creatinine-normalized overnight urinary 6-sulfatoxymelatonin. Timepoint: Before intervention and after completing 12 weeks of intervention. Method of measurement: Enzyme linked immunoassay for urinary six sulfatoxymelatonin with creatinine normalization. Cortisol awakening response. Timepoint: Before intervention and after completing 12 weeks of intervention. Method of measurement: High sensitivity salivary enzyme immunoassay for cortisol. Serum interleukin-6 (IL-6) concentration. Timepoint: Before intervention and after completing 12 weeks of intervention. Method of measurement: High sensitivity enzyme linked immunosorbent assay for serum interleukin six. Islamic Azad University Approved 2024-06-05 Ethics committee of Islamic Azad University, Shahrekord branch Islamic Azad University Shahrekord Branch, Rahmatieh, Shahrekord, Iran Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)