The Effect of Avnace eZZe on Sleep Improvement

NCT07172607 | Recruiting

• 1 other identifier: N202505031
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to examine the effectiveness of Avance eZZe drink with liposomal technology in improving sleep quality. Participants will be randomly assigned to either the placebo group, Avance eZZe drink group, and Avance eZZe drink without liposomal group, with 25 participants in each group. On the day of the experiment (day 0), participants are required to fill out questionnaires assessing sleep disorders and stress condition, and use a sleep monitoring system to track their sleep and autonomic nervous system conditions. Subsequently, participants will be given the experimental samples and instructed to consume them 1 hour before sleep daily for 28 days. Follow-up assessments will be conducted in the day-1, day-14 and day-28, participants are required to fill out questionnaires assessing sleep disorders and stress condition, and use a sleep monitoring system to track their sleep and autonomic nervous system conditions.

Conditions

Sleep Disorder (Disorder); Anxiety Depression Disorder

Outcome Measures

Primary Outcomes (3)

• Sleep monitoring

  The difference of electrocardiosignal between two specific points on the body surface will be used to reflect sleep state.

  Day-0 (baseline), Day-1, Day-14, Day-28

• Sleeping quality

  The Pittsburgh Sleep Quality Index (PSQI) will be utilized to assess sleeping quality. The minimum value is 0, the maximum value is 42. The higher the score, the worse the outcome.

  Day-0 (baseline), Day-14, Day-28

• Insomnia Severity

  The Insomnia Severity Index (ISI) will be utilized to assess insomnia severity. The total score ranges from 0 to 28, with higher scores indicating more severe insomnia.

  Day-0 (baseline), Day-14, Day-28

Secondary Outcomes (4)

• General level of daytime sleepiness

  Day-0 (baseline), Day-14, Day-28

• Depression severity

  Day-0 (baseline), Day-14, Day-28

• Anxiety severity

  Day-0 (baseline), Day-14, Day-28

• Low Frequency/High Frequence (LF/HF) ratio

  Day-0 (Baseline), Day-1, Day-14, Day-28

Study Arms (3)

Avance eZZe

EXPERIMENTAL

Dietary Supplement: Avance eZZe drink

Avance eZZe (without liposomal)

ACTIVE COMPARATOR

Dietary Supplement: Avance eZZe drink (without liposomal)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo drink

Interventions

Avance eZZe drink DIETARY_SUPPLEMENT

25 mL liquid sachet, 1 sachet/day, consume 1 sachet of the sample 1 hour before sleep daily

Avance eZZe

Avance eZZe drink (without liposomal) DIETARY_SUPPLEMENT

25 mL liquid sachet, 1 sachet/day, consume 1 sachet of the sample 1 hour before sleep daily

Avance eZZe (without liposomal)

Placebo drink DIETARY_SUPPLEMENT

25 mL liquid sachet, 1 sachet/day, consume 1 sachet of the sample 1 hour before sleep daily

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female age 18 years or older;
• Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) criteria for Insomnia Disorder;
• Regular bedtime, between 21:00 and 01:00 and regular wake time;
• Insomnia Severity Index (ISI) score ≥15;
• All medications or interventions for insomnia, mental or physical disorders must have been stable for at least four weeks prior to screening, and participants had to be willing to maintain a stable regimen throughout the study;
• No consumption of sleep or stress-related supplements for at least four weeks prior to screening;
• Willing and able to comply with all aspects of the protocol.

You may not qualify if:

• A current diagnosis of sleep-related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm sleep disorder;
• Depressive symptoms at screening were considered significantly severe with a PHQ-9 score \> 14
• Anxiety symptoms at screening were considered significantly severe with a GAD-7 score \> 15;
• Females who are breastfeeding or pregnant;
• Females of childbearing potential who are not practicing acceptable pregnancy prevention methods (NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal or have been sterilized surgically.);
• Excessive caffeine use that in the opinion of the investigator contributes to the participant's insomnia, or habitually consumes caffeine-containing beverages after 18:00 and is unwilling to forego caffeine after 18:00 for the duration of his/her participation in the study;
• History of drug or alcohol dependency or abuse within approximately the previous 2 years;
• Current evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal, neurological, or psychiatric disease or malignancy or chronic pain that in the opinion of the investigator could affect the participant's safety or interfere with the study assessments;
• Scheduled for major surgery during the study;
• Participants known to be allergic to any components of the product.

Sponsors & Collaborators

• TCI Co., Ltd.: lead

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

RECRUITING

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Hsin-Chien Lee, Doctor

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsin-Chien Lee, Doctor

CONTACT

+886-02-22490088; ellalee@tmu.edu.tw

Ping Lin

CONTACT

+886-02-87977811; candice.lin@tci-bio.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 15, 2025
• Study Start: September 9, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

TW (1)