Inulin-Spirulina Co-intervention for Insomnia Disorder
Summary
NIH National Library of Medicine registered a clinical trial (NCT07537192) on ClinicalTrials.gov investigating inulin and spirulina dietary supplements as co-interventions for insomnia disorder in adults aged 18 to 60 years. The 12-week randomized controlled trial will enroll participants in four arms (inulin, spirulina, combined, placebo) and measure sleep quality, mood, anxiety, and cognitive outcomes. Researchers will monitor adverse events and collect polysomnography and biospecimen data at baseline and week 12.
What changed
NIH registered a new clinical trial (NCT07537192) on ClinicalTrials.gov studying inulin and spirulina dietary supplements as interventions for insomnia disorder in adults aged 18-60. The 12-week randomized controlled trial will evaluate four groups (inulin alone, spirulina alone, combined treatment, placebo) using sleep quality scores, polysomnography, and biospecimen collection as primary endpoints.
Institutions conducting dietary supplement or insomnia disorder research should note this trial registration for compliance awareness. Sponsors and investigators conducting applicable clinical trials should verify NIH ClinicalTrials.gov registration requirements are met, including appropriate study design classification and adverse event monitoring protocols per GxP standards.
Archived snapshot
Apr 18, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Inulin-Spirulina Co-intervention for Insomnia Disorder
N/A NCT07537192 Kind: NA Apr 17, 2026
Abstract
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.
Conditions: Insomnia Disorder, Sleep Initiation and Maintenance Disorders
Interventions: Inulin, Spirulina, Maltodextrin
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