Insomnia Disorder, Sleep Initiation and Maintenance Disorders
Conditions
Keywords
Inulin, Spirulina, Gut Microbiota, Gut-Brain Axis, Insomnia
Brief summary
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.
Detailed description
This study is a single-center, prospective, randomized, double-blind, four-arm parallel-group clinical trial designed to evaluate the efficacy and safety of inulin and spirulina, administered alone or in combination, in adults with chronic insomnia disorder. Insomnia disorder is associated with impaired sleep quality, emotional disturbances, and reduced cognitive function. Emerging evidence suggests that dysregulation of the gut microbiota and its metabolites may play an important role in the pathophysiology of sleep disorders through the gut-brain axis. Inulin, a prebiotic dietary fiber, and spirulina, a nutrient-rich microalga with anti-inflammatory and antioxidant properties, have both been shown to modulate gut microbiota composition and metabolic activity. Their combined use may produce synergistic effects on sleep regulation and related physiological processes. In this study, eligible participants will be randomly assigned in a 1:1:1:1 ratio to receive inulin, spirulina, inulin plus spirulina, or placebo for 12 weeks. The interventions will be administered in powder form once daily, with identical appearance and packaging to ensure blinding of participants and study personnel. The primary objective is to evaluate the effect of the interventions on sleep quality. Secondary objectives include assessing changes in sleep architecture, mood and anxiety symptoms, and cognitive function. In addition, this study aims to explore potential biological mechanisms by examining changes in gut microbiota composition before and after the intervention. Plasma samples collected at baseline and week 12 will be used for exploratory metabolomic analyses to further investigate potential biological pathways associated with treatment response. Safety will be assessed throughout the study by monitoring adverse events. The findings of this study are expected to provide evidence on whether combined inulin and spirulina supplementation offers superior clinical benefits compared with single interventions or placebo, and to improve understanding of microbiota-related pathways involved in sleep regulation.
Interventions
DIETARY_SUPPLEMENTSpirulina
Spirulina is a nutrient-rich microalga with antioxidant and anti-inflammatory properties, used in this study as a dietary supplement.
DIETARY_SUPPLEMENTMaltodextrin
Maltodextrin is used as a placebo control in this study and is matched in appearance and administration to the active interventions.
DIETARY_SUPPLEMENTInulin
Inulin is a prebiotic dietary fiber used in this study to modulate gut microbiota and metabolic activity.
Sponsors
First Affiliated Hospital of Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This is a double-blind study in which participants, care providers, investigators, and outcome assessors are unaware of group assignments. All study products are identical in appearance, packaging, weight, and taste, and are labeled with randomization codes managed by independent personnel.
Intervention model description
A randomized, double-blind, four-arm parallel-group study in which participants are assigned in a 1:1:1:1 ratio to receive inulin, spirulina, inulin plus spirulina, or placebo for 12 weeks.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18 to 60 years; 2. Meet the ICSD-3 diagnostic criteria for chronic insomnia disorder; 3. Pittsburgh Sleep Quality Index (PSQI) total score \> 5; 4. Willing to participate and provide written informed consent.
Exclusion criteria
1. Use of prebiotics, probiotics, high-fiber supplements, or microbiota-related products within the past 8 weeks; 2. Diagnosis of psychiatric disorders other than insomnia based on DSM-5 criteria, assessed using the Mini-International Neuropsychiatric Interview (MINI); 3. 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); 4. Severe hepatic or renal dysfunction, hematologic disorders, or respiratory diseases; 5. Severe gastrointestinal diseases or malnutrition; 6. Pregnancy or breastfeeding; 7. Apnea-hypopnea index \> 10, or periodic limb movement index \> 15/hour on polysomnography; 8. Known allergy or intolerance to inulin, spirulina, or maltodextrin; 9. Participation in another clinical trial within the past 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pittsburgh Sleep Quality Index (PSQI) Score | Baseline to Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Sleep Time Assessed by Polysomnography | Baseline, Week 2, Week 4, Week 8, and Week 12 | Change in total sleep time measured by overnight polysomnography. Total sleep time will be reported in minutes. |
| Change in Sleep Latency Assessed by Polysomnography | Baseline, Week 2, Week 4, Week 8, and Week 12 | Change in sleep latency measured by overnight polysomnography. Sleep latency will be reported in minutes. |
| Change in Wake After Sleep Onset Assessed by Polysomnography | Baseline, Week 2, Week 4, Week 8, and Week 12 | Change in wake after sleep onset measured by overnight polysomnography. Wake after sleep onset will be reported in minutes. |
| Change in Hamilton Depression Rating Scale-24 (HAMD-24) Total Score | Baseline, Week 2, Week 4, Week 8, and Week 12 | 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. |
| Change in Hamilton Anxiety Rating Scale (HAMA) Total Score | Baseline, Week 2, Week 4, Week 8, and Week 12 | Change in Hamilton Anxiety Rating Scale total score from baseline to week 12. The Hamilton Anxiety Rating Scale is a clinician-rated scale for anxiety severity with a total score range of 0 to 56, where higher scores indicate worse anxiety symptoms. |
| Change in MATRICS Consensus Cognitive Battery (MCCB) Overall Composite T Score | Baseline, Week 2, Week 4, Week 8, and Week 12 | Change in MATRICS Consensus Cognitive Battery overall composite T score from baseline to week 12. The MATRICS Consensus Cognitive Battery assesses cognitive performance across multiple cognitive domains. Higher scores indicate better cognitive performance. |
| Change in Relative Abundance of Gut Microbiota Taxa Assessed by 16S rRNA Sequencing | Baseline, Week 2, Week 4, Week 8, and Week 12 | Change in relative abundance of gut microbiota taxa in stool samples from baseline to week 12, assessed by 16S rRNA sequencing. |
Contacts
CONTACTJing Lu, PhD
CONTACTWenhao Chen, MD
PRINCIPAL_INVESTIGATORJing Lu, PhD
Zhejiang University
Outcome results
None listed