Inulin-Spirulina Co-intervention for Insomnia Disorder (NCT07537192) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Inulin-Spirulina Co-intervention for Insomnia Disorder
180 participantsStarted 2026-05-01
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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;
✕. Severe gastrointestinal diseases or malnutrition;
What they're measuring
1
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Timeframe: Baseline to Week 12
Trial details
NCT IDNCT07537192
SponsorFirst Affiliated Hospital of Zhejiang University