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Testing the Cognitive Facilitation Effect by Dietary Supplementation of MelaGene+ Drink

Sponsor
TCI Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT05988593
Collaborator
(none)
64
Enrollment
1
Location
2
Arms
8.9
Actual Duration (Months)
7.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To assess the efficacy of MelaGene+ on cognitive performance

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: placebo
  • Dietary Supplement: MelaGene+
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
Testing the Cognitive Facilitation Effect by Dietary Supplementation of MelaGene+ Drink
Actual Study Start Date :
Sep 1, 2022
Actual Primary Completion Date :
Nov 30, 2022
Actual Study Completion Date :
May 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: placebo drink

Dietary Supplement: placebo
consume one bottle (30 mL) per day
Experimental: MelaGene+

Dietary Supplement: MelaGene+
consume one bottle (30 mL) per day
Other Names:
  • Melaleuca-MelaGene+

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The change of Match to sample test [Change from Baseline match to sample test value at 8 weeks]

      The number of memorized cards was utilized to measure Match to sample test value.

    2. The change of Trail making test [Change from Baseline Trail making test value at 8 weeks]

      The time of finishing actions was utilized to measure Trail making test value.

    3. The change of Processing speed test [Change from Baseline Processing speed test value at 8 weeks]

      The number of pressing buttons was utilized to measure Processing speed test value.

    4. The change of Mnemonic Similarity Task [Change from Baseline Mnemonic Similarity Task value at 8 weeks]

      The proportion of correction about ability on memorizing old things was utilized to measure Mnemonic Similarity Task value.

    5. The change of facial expression cuing task [Change from Baseline facial expression cuing task value at 8 weeks]

      The correction of evaluation on facial emotion was utilized to measure facial expression cuing task value.

    6. The change of State-trait anxiety inventory [Change from Baseline State-trait anxiety inventory value at 8 weeks]

      The scores of anxiety state was utilized to measure State-trait anxiety inventory value.

    7. The change of score of fatigue [Change from Baseline PSS (The Perceived Stress Scale)-14 value at 8 weeks]

      The PSS (The Perceived Stress Scale)-14 questionnaire was utilized to measure fatigue condition.

    8. The change of score of life quality [Change from Baseline WHOQOL-BREF (The World Health Organization Quality of Life Brief Version) value at 8 weeks]

      The WHOQOL-BREF (The World Health Organization Quality of Life Brief Version) questionnaire was utilized to measure life quality.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 20 to 65-year-old males or females
    Exclusion Criteria:

    • Participants are breastfeeding, pregnant or planning to become pregnant during the test (self-report)

    • Participants with heart, liver, kidney, endocrine and other major organic diseases (self-reported)

    • Participants take drugs for a long time (self-report)

    • Participants with mental illness or have undergone brain surgery

    • Participants still can not clearly see words with 12pt on computer after corrected vision

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 China Medical University Taichung Taiwan

    Sponsors and Collaborators

    • TCI Co., Ltd.

    Investigators

    • Principal Investigator: Jing-Ling Li, China Medical University, China

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    TCI Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT05988593
    Other Study ID Numbers:
    • CMUH111-REC3-127
    First Posted:
    Aug 14, 2023
    Last Update Posted:
    Aug 14, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 14, 2023