Inulin-Spirulina Co-intervention for Insomnia Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorFirst Affiliated Hospital of Zhejiang University
About this trial
The goal of this clinical trial is to learn if inulin and spirulina, used alone or in combination, can improve insomnia disorder in adults aged 18 to 60 years with chronic insomnia disorder. It will also learn about the safety of these interventions. The main questions it aims to answer are:
Does inulin plus spirulina improve sleep quality, as measured by the reduction rate in Pittsburgh Sleep Quality Index (PSQI) score? Does the intervention improve sleep-related, mood, anxiety, and cognitive outcomes after 12 weeks? Researchers will compare an inulin group, a spirulina group, a combined inulin plus spirulina group, and a placebo group to see if the combined intervention provides greater benefit than either single intervention or placebo.
Participants will:
be randomly assigned to 1 of 4 groups: inulin, spirulina, inulin plus spirulina, or placebo; take the assigned study product once daily for 12 weeks; complete sleep, mood, anxiety, and cognitive assessments at baseline and week 12; undergo polysomnography and provide blood and stool samples at baseline and week 12; and be monitored for adverse events throughout the study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 to 60 years;
Meet the ICSD-3 diagnostic criteria for chronic insomnia disorder;
Pittsburgh Sleep Quality Index (PSQI) total score > 5;
Willing to participate and provide written informed consent.
Disqualifiers
Use of prebiotics, probiotics, high-fiber supplements, or microbiota-related products within the past 8 weeks;
Diagnosis of psychiatric disorders other than insomnia based on DSM-5 criteria, assessed using the Mini-International Neuropsychiatric Interview (MINI);
Regular use of sedative or hypnotic medications within the past 4 weeks, or frequent intermittent use (e.g., benzodiazepines, non-benzodiazepine receptor agonists, melatonin receptor agonists, sedating antihistamines);
Severe hepatic or renal dysfunction, hematologic disorders, or respiratory diseases;
Trial design
Design model
Parallel
Treatments tested in this trial
Inulin
Dietary supplementInulin is a prebiotic dietary fiber used in this study to modulate gut microbiota and metabolic activity.
Spirulina
Dietary supplementSpirulina is a nutrient-rich microalga with antioxidant and anti-inflammatory properties, used in this study as a dietary supplement.
Maltodextrin
Dietary supplementMaltodextrin is used as a placebo control in this study and is matched in appearance and administration to the active interventions.
Treatment groups
180 Participants
are divided into 4 treatment groupsGroup A: Inulin plus SpirulinaExperimental treatment 2 interventions
Group B: InulinExperimental treatment 2 interventions
Group C: SpirulinaExperimental treatment 2 interventions
Group D: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Pittsburgh Sleep Quality Index (PSQI) Score
The primary outcome is the change in Pittsburgh Sleep Quality Index (PSQI) total score from baseline to week 12. The PSQI is a validated self-reported questionnaire assessing sleep quality, with higher scores indicating worse sleep. The outcome will be analyzed as the difference between baseline and post-intervention scores.
Time frame
Baseline to Week 12Secondary outcomes
1
Change in Total Sleep Time Assessed by Polysomnography
Change in total sleep time measured by overnight polysomnography. Total sleep time will be reported in minutes.
Time frame
Baseline, Week 2, Week 4, Week 8, and Week 122
Change in Sleep Latency Assessed by Polysomnography
Change in sleep latency measured by overnight polysomnography. Sleep latency will be reported in minutes.
Time frame
Baseline, Week 2, Week 4, Week 8, and Week 123
Change in Wake After Sleep Onset Assessed by Polysomnography
Change in wake after sleep onset measured by overnight polysomnography. Wake after sleep onset will be reported in minutes.
Time frame
Baseline, Week 2, Week 4, Week 8, and Week 124
Change in Hamilton Depression Rating Scale-24 (HAMD-24) Total Score
Change in Hamilton Depression Rating Scale-24 total score from baseline to week 12. The Hamilton Depression Rating Scale-24 is a clinician-rated scale for depressive symptom severity with a total score range of 0 to 76, where higher scores indicate worse depressive symptoms.
Time frame
Baseline, Week 2, Week 4, Week 8, and Week 12Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: