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
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220208053971N7
Registration date:2026-09-04, 1405/06/13
Registration timing:prospective
Last update:2026-09-04, 1405/06/13
Update count:0
Registration date
2026-09-04, 1405/06/13
Registrant information
Name
Hamed Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 1444
Email address
hmohamadi@sina.tums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-10-23, 1405/08/01
Expected recruitment end date
2028-10-22, 1407/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of inositol supplementation on sleep quality, fatigue and mood status in women with poor sleep quality: a randomized control trial
Public title
The effects of inositol supplementation on sleep quality, fatigue and mood status in women with poor sleep quality
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 20 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Imam Khomeini Hospital Complex- Tehran University of Medical Sciences
Street address
Tehran, at the end of Keshavarz Boulevard, Imam Khomeini Hospital Complex
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Approval date
2026-08-16, 1405/05/25
Ethics committee reference number
IR.TUMS.IKHC.REC.1405.225
Health conditions studied
1
Description of health condition studied
sleep quality
ICD-10 code
ICD-10 code description
2
Description of health condition studied
fatigue
ICD-10 code
ICD-10 code description
3
Description of health condition studied
mood status
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sleep Quality
Timepoint
Before the start of the intervention, 4 and 8 weeks after
Method of measurement
(Pittsburgh Sleep Quality Index; PSQI)
2
Description
Fatigue
Timepoint
Before the start of the intervention, 4 and 8 weeks after
Method of measurement
(Fatigue Assessment Scale; FAS)
3
Description
Mood status
Timepoint
Before the start of the intervention, 4 and 8 weeks after
Before the start of the intervention, 4 and 8 weeks after
Method of measurement
(Insomnia Severity Index; ISI)
2
Description
Daytime sleepiness
Timepoint
Before the start of the intervention, 4 and 8 weeks after
Method of measurement
(Epworth Sleepiness Scale; ESS)
3
Description
Body weight
Timepoint
Before the start of the intervention and 8 weeks after
Method of measurement
Digital scale
Intervention groups
1
Description
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.
Category
Other
2
Description
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.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
nutrition and diet therapy clinic of the School of Nutrition, Tehran University of Medical Sciences.
Full name of responsible person
Dr.Hamed Mohammadi
Street address
Dr. Gharib Street, corner of Sadoghi Street, No. 119, Unit 4, First Floor.
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 6656 4137
Email
Info_snsd@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ali Akbari Sari
Street address
Keshavarz Blvd., corner of Quds St., Central Organization of the University, 6th floor of Research and Technology Vice-Chancellor
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
vcr@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?