Inulin-Spirulina Co-intervention for Insomnia Disorder

NCT07537192 | Not Yet Recruiting

• 1 other identifier: IIT20250259C-R1
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Insomnia Disorder; Sleep Initiation and Maintenance Disorders

Keywords

Inulin; Spirulina; Gut Microbiota; Gut-Brain Axis; Insomnia

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to Week 12

Secondary Outcomes (7)

• Change in Total Sleep Time Assessed by Polysomnography

  Baseline to Week 12

• Change in Sleep Latency Assessed by Polysomnography

  Baseline to Week 12

• Change in Wake After Sleep Onset Assessed by Polysomnography

  Baseline to Week 12

• Change in Hamilton Depression Rating Scale-24 (HAMD-24) Total Score

  Baseline to Week 12

• Change in Hamilton Anxiety Rating Scale (HAMA) Total Score

  Baseline to Week 12

Study Arms (4)

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.

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.

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.

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.

Dietary Supplement: Maltodextrin

Interventions

Inulin DIETARY_SUPPLEMENT

Inulin is a prebiotic dietary fiber used in this study to modulate gut microbiota and metabolic activity.

Also known as: Fructooligosaccharide

Inulin; Inulin plus Spirulina

Spirulina DIETARY_SUPPLEMENT

Spirulina is a nutrient-rich microalga with antioxidant and anti-inflammatory properties, used in this study as a dietary supplement.

Also known as: Arthrospira platensis

Inulin plus Spirulina; Spirulina

Maltodextrin DIETARY_SUPPLEMENT

Maltodextrin is used as a placebo control in this study and is matched in appearance and administration to the active interventions.

Also known as: Placebo

Inulin; Placebo; Spirulina

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Inulin; fructooligosaccharide; maltodextrin

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides

Study Officials

• Jing Lu, PhD

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Lu, PhD

CONTACT

15858200010; Lujing2016@zju.edu.cn

Wenhao Chen, MD

CONTACT

19857175751; chenwenhao@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 17, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share