Insomnia DisorderNCT07537192
Inulin-Spirulina Co-intervention for Insomnia Disorder
A study testing Inulin, Spirulina and Maltodextrin in people with Insomnia Disorder and Sleep Initiation and Maintenance Disorders, run by First Affiliated Hospital of Zhejiang University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Insomnia Disorder, Sleep Initiation and Maintenance Disorders
- What is being tested?
- Inulin, Spirulina and Maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
- Pregnancy or breastfeeding;
Show all 9Show fewer
- Apnea-hypopnea index > 10, or periodic limb movement index > 15/hour on polysomnography;
- Known allergy or intolerance to inulin, spirulina, or maltodextrin;
- Participation in another clinical trial within the past 3 months.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Investigation of the Therapeutic Efficacy and Mechanistic Pathways of Inulin-Spirulina Co-intervention in Patients With Insomnia Disorder: A Randomized Controlled 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.
Read more
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.
Read the 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.
- Being tested
- Inulin, Spirulina, Maltodextrin
- Keywords
- Inulin, Spirulina, Gut Microbiota, Gut-Brain Axis, Insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InulinDietary supplement
Also called Fructooligosaccharide
Inulin is a prebiotic dietary fiber used in this study to modulate gut microbiota and metabolic activity.
SpirulinaDietary supplement
Also called Arthrospira platensis
Spirulina is a nutrient-rich microalga with antioxidant and anti-inflammatory properties, used in this study as a dietary supplement.
MaltodextrinDietary supplement
Also called Placebo
Maltodextrin is used as a placebo control in this study and is matched in appearance and administration to the active interventions.
| Study group | Role | What they receive |
|---|---|---|
| Inulin plus Spirulina | Experimental | Participants receive 15 g inulin plus 5 g spirulina dissolved in warm water, taken orally once daily after breakfast for 12 weeks. Receives: Dietary Supplement: Inulin; Dietary Supplement: Spirulina |
| Inulin | Experimental | Participants receive 15 g inulin plus 5 g maltodextrin dissolved in warm water, taken orally once daily after breakfast for 12 weeks. Receives: Dietary Supplement: Inulin; Dietary Supplement: Maltodextrin |
| Spirulina | Experimental | Participants receive 5 g spirulina plus 15 g maltodextrin dissolved in warm water, taken orally once daily after breakfast for 12 weeks. Receives: Dietary Supplement: Spirulina; Dietary Supplement: Maltodextrin |
| Placebo | Placebo comparator | Participants receive 20 g maltodextrin dissolved in warm water, taken orally once daily after breakfast for 12 weeks. Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 12
Secondary outcomes (7)
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.
Measured: Baseline, Week 2, Week 4, Week 8, and Week 12
Change in Sleep Latency Assessed by Polysomnography
Change in sleep latency measured by overnight polysomnography. Sleep latency will be reported in minutes.
Measured: Baseline, Week 2, Week 4, Week 8, and Week 12
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.
Measured: Baseline, Week 2, Week 4, Week 8, and Week 12
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.
Measured: Baseline, Week 2, Week 4, Week 8, and Week 12
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score
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.
Measured: Baseline, Week 2, Week 4, Week 8, and Week 12
Change in MATRICS Consensus Cognitive Battery (MCCB) Overall Composite T Score
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.
Measured: Baseline, Week 2, Week 4, Week 8, and Week 12
Change in Relative Abundance of Gut Microbiota Taxa Assessed by 16S rRNA Sequencing
Change in relative abundance of gut microbiota taxa in stool samples from baseline to week 12, assessed by 16S rRNA sequencing.
Measured: Baseline, Week 2, Week 4, Week 8, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Lu, PhD, First Affiliated Hospital of Zhejiang University
- Investigators
- Jing Lu, PhD, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537192
- Sponsor's protocol ID
- IIT20250259C-R2
- Status last verified
- May 2026
- First submitted
- 6 Apr 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Therapeutic Efficacy and Mechanistic Pathways of Inulin-Spirulina Co-intervention in Patients With Insomnia Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07537192
- Acronym / sponsor ID
- IIT20250259C-R2
- Keywords
- Inulin, Spirulina, Gut Microbiota, Gut-Brain Axis, Insomnia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Inulin plus Spirulina | Experimental | Dietary Supplement: Inulin, Dietary Supplement: SpirulinaParticipants receive 15 g inulin plus 5 g spirulina dissolved in warm water, taken orally once daily after breakfast for 12 weeks. |
| Inulin | Experimental | Dietary Supplement: Inulin, Dietary Supplement: MaltodextrinParticipants receive 15 g inulin plus 5 g maltodextrin dissolved in warm water, taken orally once daily after breakfast for 12 weeks. |
| Spirulina | Experimental | Dietary Supplement: Spirulina, Dietary Supplement: MaltodextrinParticipants receive 5 g spirulina plus 15 g maltodextrin dissolved in warm water, taken orally once daily after breakfast for 12 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: MaltodextrinParticipants receive 20 g maltodextrin dissolved in warm water, taken orally once daily after breakfast for 12 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InulinAlso: FructooligosaccharideInulin is a prebiotic dietary fiber used in this study to modulate gut microbiota and metabolic activity. | Dietary supplement | Inulin, Inulin plus Spirulina |
| SpirulinaAlso: Arthrospira platensisSpirulina is a nutrient-rich microalga with antioxidant and anti-inflammatory properties, used in this study as a dietary supplement. | Dietary supplement | Inulin plus Spirulina, Spirulina |
| MaltodextrinAlso: PlaceboMaltodextrin is used as a placebo control in this study and is matched in appearance and administration to the active interventions. | Dietary supplement | Inulin, Placebo, Spirulina |
Primary outcome
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: 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.
7 secondary outcomes
Change in Total Sleep Time Assessed by Polysomnography
Time frame: Baseline, Week 2, Week 4, Week 8, and Week 12
Change in Sleep Latency Assessed by Polysomnography
Time frame: Baseline, Week 2, Week 4, Week 8, and Week 12
Change in Wake After Sleep Onset Assessed by Polysomnography
Time frame: Baseline, Week 2, Week 4, Week 8, and Week 12
Change in Hamilton Depression Rating Scale-24 (HAMD-24) Total Score
Time frame: Baseline, Week 2, Week 4, Week 8, and Week 12
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score
Time frame: Baseline, Week 2, Week 4, Week 8, and Week 12
Change in MATRICS Consensus Cognitive Battery (MCCB) Overall Composite T Score
Time frame: Baseline, Week 2, Week 4, Week 8, and Week 12
Change in Relative Abundance of Gut Microbiota Taxa Assessed by 16S rRNA Sequencing
Time frame: Baseline, Week 2, Week 4, Week 8, and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jing Lu, PhD principal investigator
First Affiliated Hospital of Zhejiang University
Questions about this trial
What is this clinical trial studying?
A study testing Inulin, Spirulina and Maltodextrin in people with Insomnia Disorder and Sleep Initiation and Maintenance Disorders, run by First Affiliated Hospital of Zhejiang University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Lu, PhD (15858200010, Lujing2016@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pittsburgh Sleep Quality Index (PSQI) Score (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026; AzTrials last refreshed its copy on 31 Oct 2026.