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Could a Gut-Focused supplement combo cure your insomnia?

NCT ID NCT07537192

Symptom relief Sponsor: First Affiliated Hospital of Zhejiang University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether taking inulin (a prebiotic fiber) and spirulina (a nutrient-rich algae), alone or together, can improve sleep in adults aged 18 to 60 with chronic insomnia. Over 12 weeks, 180 participants will take one of four options: inulin, spirulina, both, or a placebo. They will complete sleep questionnaires, undergo sleep monitoring, and provide blood and stool samples to see how the supplements affect sleep and overall health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Inulin and spirulina dietary supplements
What this could lead to
If it works, this could point toward a natural, gut-focused supplement option for improving sleep quality in people with chronic insomnia.
What could go wrong
This is an early-stage trial with no phase, so results are uncertain. The supplements may not improve sleep more than placebo, and individual responses can vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

insomnia sleep disorder, initiating and maintaining sleep

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Insomnia disorder Sleep initiation and maintenance disorders

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.