The Effect of Avnace eZZe on Sleep Improvement

Обзор

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.

Вмешательства

• Пищевая добавка Avance eZZe drink
  25 mL liquid sachet, 1 sachet/day, consume 1 sachet of the sample 1 hour before sleep daily
• Пищевая добавка Avance eZZe drink (without liposomal)
  25 mL liquid sachet, 1 sachet/day, consume 1 sachet of the sample 1 hour before sleep daily
• Пищевая добавка Placebo drink
  25 mL liquid sachet, 1 sachet/day, consume 1 sachet of the sample 1 hour before sleep daily

Первичные конечные точки

• Sleep monitoring [Срок оценки: Day-0 (baseline), Day-1, Day-14, Day-28]
• Sleeping quality [Срок оценки: Day-0 (baseline), Day-14, Day-28]
• Insomnia Severity [Срок оценки: Day-0 (baseline), Day-14, Day-28]

Вторичные конечные точки (4)

• General level of daytime sleepiness [Срок оценки: Day-0 (baseline), Day-14, Day-28]
• Depression severity [Срок оценки: Day-0 (baseline), Day-14, Day-28]
• Anxiety severity [Срок оценки: Day-0 (baseline), Day-14, Day-28]
• Low Frequency/High Frequence (LF/HF) ratio [Срок оценки: Day-0 (Baseline), Day-1, Day-14, Day-28]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• Taipei Medical University — Taipei

Идентификаторы

NCT: NCT07172607 · N202505031

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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