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Study aim: Determining the effect of inositol supplement consumption on sleep quality, fatigue, and mood in women with low sleep quality. Design: A controlled, parallel-group, double-blinded, randomized, clinical trial on 60 patients Settings and conduct: his study is a randomized, double-blind, placebo-controlled trial conducted on eligible women with low sleep quality. Participants, are randomly allocated into two groups receiving either inositol or placebo daily and take 2 tablets daily for 8 weeks. Assessments include sleep quality, fatigue, and mood at three stages (baseline, week 4, and end of study). Weight, height, and body composition are also measured at the beginning and end of the intervention. All assessments will be performed during the follicular phase of the menstrual cycle. Participants/Inclusion and exclusion criteria: Inclusion Criteria: Women with a (PSQI) score > 5 Body Mass Index (BMI) between 18.5 and 29.9 kg/m². Age between 20-50 years. Exclusion Criteria: General health problems (chronic illnesses or severe psychiatric disorders). Presence of (PCOS). Hyperthyroidism or hypothyroidism. History of disorders affecting sleep quality. Shift work. History of any hormone therapy. Travel to a different time zone within the past 1 month. Consumption of sleep supplements within the last 4 weeks. Menopause. Experiencing a significant stressor within the last 2 weeks. Smoking. Use of medications that may affect cognitive function or sleep within the last month Caffeine intake exceeding 300 mg. Diagnosis of any dementia or neurodegenerative disease. Pregnancy or breastfeeding. Individuals on weight reduction diets. Student examination periods. Intervention groups: Intervention Group: 1600 mg inositol hexaphosphate daily. Control Group: 1600 mg maltodextrin placebo daily. Both groups: 2 tablets daily after dinner for 8 weeks Main outcome variables: sleep quality, fatigue mood status
IRCTID: IRCT20220208053971N7
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