Avance eZZe drink for improving sleep in adults with insomnia

The Effect of Avnace eZZe on Sleep Improvement

This trial tests whether drinking Avance eZZe with liposomal technology one hour before bed helps adults with insomnia sleep better over 28 days.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: TCI Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Taipei)
• Trial ID: NCT07172607 on ClinicalTrials.gov

What this trial studies

This randomized, interventional trial assigns adults with DSM-5 insomnia to one of three groups—Avance eZZe with liposomal technology, Avance eZZe without liposomes, or a placebo—with 25 participants per group. Participants complete baseline questionnaires and use a sleep monitoring system to record sleep and autonomic nervous system measures, then consume their assigned drink nightly one hour before bedtime for 28 days. Follow-up questionnaires and sleep monitoring are repeated on day 14 and day 28 to track changes in sleep quality and stress-related measures. Eligible participants must be 18 or older, have an Insomnia Severity Index score ≥15, maintain regular bed/wake times, and keep stable medications or interventions for at least four weeks.

Who should consider this trial

Good fit: Adults aged 18 or older who meet DSM-5 criteria for insomnia, have an ISI score ≥15, maintain stable medication/supplement regimens, and have regular bed and wake times are ideal candidates.

Not a fit: Patients with sleep-related breathing disorders, restless legs syndrome, circadian rhythm disorders, severe depression or anxiety, or those unwilling to maintain stable treatments or attend in-person visits are unlikely to benefit.

Why it matters

Potential benefit: If effective, the drink could provide a simple nightly supplement that improves sleep quality and reduces insomnia severity for some patients.

How similar studies have performed: Prior studies of oral nutritional or liposomal sleep formulations have shown mixed and limited results, so this specific liposomal Avance eZZe formulation is relatively untested.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where this trial is running

Taipei

• Taipei Medical University — Taipei, Taiwan (Recruiting)

Study contacts

• Principal investigator: Hsin-Chien Lee, Doctor — Taipei Medical University
• Study coordinator: Hsin-Chien Lee, Doctor

Conditions Sleep Disorder; Anxiety Depression Disorder