]>
IRCT20220208053971N7 IRCT 2026-09-04 Tehran University of Medical Sciences The effects of inositol supplementation on sleep quality, fatigue and mood status in women with poor sleep quality The effects of inositol supplementation on sleep quality, fatigue and mood status in women with poor sleep quality: a randomized control trial 2026-10-23 anticipated 60 Recruiting https://irct.ir/trial/89376 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization will be performed using permuted block randomization, taking into account the variables age (20–35 and 35–50 years) and body mass index (18.5–24.9 and 25–29.9 kg/m²). Eligible participants will be randomly allocated to either the intervention or placebo group using stratified block randomization based on age group (20–35 and 36–50 years) and body mass index (BMI) (18.5–24.9 and 25–29.9 kg/m²). The randomization sequence will be generated using [www.randomization.com](http://www.randomization.com). Within each stratum, participants will be allocated to the two study groups in a 1:1 ratio using blocks of four. To maintain blinding, the two study groups will be designated by the codes A and B, and the randomization sequence and group codes will be generated and assigned by an individual independent of the research team, Blinding description: The study will be conducted in a double-blind manner, such that the participants, researcher, and data analyst will be blinded to the type of intervention. The intervention supplement and placebo will be identical in terms of shape, size, packaging, and appearance and will be provided using assigned codes. The codes will be kept by an independent individual until the completion of the statistical analysis. 2 Condition 1: sleep quality. Condition 2: fatigue. Condition 3: mood status. Intervention 1: Intervention group: intervention group will receive 1600 mg of inositol hexaphosphate (IP6) supplement per day, produced by M‑Plus. Each participant will take two tablets daily after dinner for a duration of eight weeks. Intervention 2: Control group: The control group will receive 1600 mg of maltodextrin daily as a placebo, provided in identical packaging and appearance. Each participant will take two tablets daily after dinner for a duration of eight weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is Because the participants information is confidential, it cannot be published.
public Dr.Hamed Mohammadi
No. 44, Shahid Hojjat Doost Alley, Naderi St, Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1416643931 0098 21 889900285 mohamadihd@gmail.com Tehran University of Medical Sciences scientific Dr.Hamed Mohammadi
No. 44, Shahid Hojjat Doost Alley, Naderi St, Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1416643931 0098 21 889900285 mohamadihd@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Women with a Pittsburgh Sleep Quality Index (PSQI) score > 5 indicating poor sleep quality Body mass index (BMI) between 18.5 and 29.9 kg/m² Age between 20 and 50 years 20 years 50 years Female General health problems (chronic diseases or severe psychiatric disorders) Presence of polycystic ovary syndrome (PCOS) Hyperthyroidism or hypothyroidism History of disorders affecting sleep quality Shift work History of any hormone therapy History of traveling to a different time zone within the past month Use of sleep supplements (magnesium and melatonin) within the past 4 weeks Menopause Experience of an event that caused severe stress within the past 2 weeks Smoking Use of medications that may affect cognitive function or sleep in the past month (sleeping medications, antidepressants), including:• Anticonvulsants• Barbiturates• Benzodiazepines• Antidepressants• Neuroleptics Alcohol consumption Caffeine intake greater than 300 mg Diagnosis of any dementia or neurodegenerative disease Pregnancy or lactation Inability to understand or sign the informed consent form Individuals on weight‑loss diets Exam season for students Other Other Intervention group: intervention group will receive 1600 mg of inositol hexaphosphate (IP6) supplement per day, produced by M‑Plus. Each participant will take two tablets daily after dinner for a duration of eight weeks. Control group: The control group will receive 1600 mg of maltodextrin daily as a placebo, provided in identical packaging and appearance. Each participant will take two tablets daily after dinner for a duration of eight weeks. Sleep Quality. Timepoint: Before the start of the intervention, 4 and 8 weeks after. Method of measurement: (Pittsburgh Sleep Quality Index; PSQI). Fatigue. Timepoint: Before the start of the intervention, 4 and 8 weeks after. Method of measurement: (Fatigue Assessment Scale; FAS). Mood status. Timepoint: Before the start of the intervention, 4 and 8 weeks after. Method of measurement: (Beck Anxiety Inventory; BAI) (Beck Depression Inventory–II; BDI-II)(Perceived Stress Scale; PSS). Insomnia Severity. Timepoint: Before the start of the intervention, 4 and 8 weeks after. Method of measurement: (Insomnia Severity Index; ISI). Daytime sleepiness. Timepoint: Before the start of the intervention, 4 and 8 weeks after. Method of measurement: (Epworth Sleepiness Scale; ESS). Body weight. Timepoint: Before the start of the intervention and 8 weeks after. Method of measurement: Digital scale. Tehran University of Medical Sciences Approved 2026-08-16 Research Ethics Committee of Imam Khomeini Hospital Complex- Tehran University of Medical Sciences Tehran, at the end of Keshavarz Boulevard, Imam Khomeini Hospital Complex Tehran Tehran Iran (Islamic Republic of)