The Effect of Adaptogen Elixir on Sleep Improvement

This study aims to examine the effectiveness of Adaptogen Elixir herbal drink in relieving emotions and improving sleep quality. Participants will be randomly assigned to either the placebo group or the Adaptogen Elixir herbal drink group, with 25 participants in each group. On the day of the experiment (week 0), participants are required to collect blood and saliva samples, 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 continuously for 4 weeks following the instruction. Follow-up assessments will be conducted in the 2nd and 4th weeks, participants are required to collect blood and saliva samples, fill out questionnaires assessing sleep disorders and stress condition, and use a sleep monitoring system to track their sleep and autonomic nervous system conditions.

Study Overview

• Status: Recruiting
• Conditions: Sleep Disorder; Anxiety Disorders
• Intervention / Treatment: Dietary supplement: Placebo drink; Dietary supplement: Adaptogen Elixir drink

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ping Lin; Phone Number: +886-02-87977811; Email: candice.lin@tci-bio.com
• Study Contact Backup: Name: Hsin-Chien Lee, Doctor; Phone Number: 79213/8158 +886-02-22490088; Email: ellalee@tmu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Taipei Medical University
    • Contact: Hsin-Chien Lee, Doctor; Phone Number: 79213/8158 +886-02-22490088; Email: ellalee@tmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adults aged above 18 years old.
• Individuals experiencing insomnia issues (PSQI > 5) or high levels of anxiety (GAD-7 > 9).
• No medication use or regular use of sleeping pills or antidepressants in the past month.
• No ongoing mental illnesses.
• No ongoing physical illnesses.
• No other sleep disorders.
• No circadian rhythm issues.
• No consumption of sleep or stress-related supplements in the past month.

Exclusion Criteria:

• Pregnant or breastfeeding women.
• Individuals with significant organic diseases such as organ transplants, epilepsy or seizures, liver or kidney diseases, malignant tumors, endocrine disorders, or a history of alcohol or substance use disorders.
• Individuals known to be allergic to any components of the product.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo drink; consume 1 drink per day for 4 weeks	Dietary supplement: Placebo drink; consume 1 drink per day for 4 weeks
Experimental: Adaptogen Elixir drink; consume 1 drink per day for 4 weeks	Dietary supplement: Adaptogen Elixir drink; consume 1 drink per day for 4 weeks; Other Names: Isagenix-Adaptogen Elixir

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep monitoring	The difference of electrocardiosignal between two specific points on the body surface will be used to reflect sleep state.	Week 0 (Baseline), Week 2, Week 4
Sleeping qualityy	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.	Week 0 (Baseline), Week 2, Week 4
Sleeping disorders	Insomnia Severity Index (ISI) will be utilized to assess sleeping disorders. The minimum value is 0, the maximum value is 28. The higher the score, the worse the outcome.	Week 0 (Baseline), Week 2, Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropeptide Y concentration	Venous blood samples will be collected to measure concentrations of Neuropeptide Y.	Week 0 (Baseline), Week 2, Week 4
Cortisol concentration	Saliva samples will be collected to measure concentrations of cortisol.	Week 0 (Baseline), Week 2, Week 4
Anxiety	Generalized Anxiety Disorder-7 (GAD-7) will be utilized to assess anxiety. The minimum value is 0, the maximum value is 21. The higher the score, the worse the outcome.	Week 0 (Baseline), Week 2, Week 4
Low Frequency/High Frequence (LF/HF) ratio	A sleep monitoring system will be utilized to measure LF/HF ratio	Week 0 (Baseline), Week 2, Week 4

Collaborators and Investigators

• Sponsor: TCI Co., Ltd.
• Investigators: Principal Investigator: Hsin-Chien Lee, Doctor, Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2024
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 19, 2024
• First Submitted That Met QC Criteria: February 26, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Adaptogen
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders; Anxiety Disorders
• Other Study ID Numbers: N202311065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No