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

NCT05988593 | Completed

• 1 other identifier: CMUH111-REC3-127
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the efficacy of MelaGene+ on cognitive performance

Conditions

Cognitive Change

Outcome Measures

Primary Outcomes (8)

• The change of Match to sample test

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

  Change from Baseline match to sample test value at 8 weeks

• The change of Trail making test

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

  Change from Baseline Trail making test value at 8 weeks

• The change of Processing speed test

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

  Change from Baseline Processing speed test value at 8 weeks

• The change of Mnemonic Similarity Task

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

  Change from Baseline Mnemonic Similarity Task value at 8 weeks

• The change of facial expression cuing task

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

  Change from Baseline facial expression cuing task value at 8 weeks

• The change of State-trait anxiety inventory

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

  Change from Baseline State-trait anxiety inventory value at 8 weeks

• The change of score of fatigue

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

  Change from Baseline PSS (The Perceived Stress Scale)-14 value at 8 weeks

• The change of score of life quality

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

  Change from Baseline WHOQOL-BREF (The World Health Organization Quality of Life Brief Version) value at 8 weeks

Study Arms (2)

placebo drink

PLACEBO COMPARATOR

Dietary Supplement: placebo

MelaGene+

EXPERIMENTAL

Dietary Supplement: MelaGene+

Interventions

placebo DIETARY_SUPPLEMENT

consume one bottle (30 mL) per day

placebo drink

MelaGene+ DIETARY_SUPPLEMENT

consume one bottle (30 mL) per day

Also known as: Melaleuca-MelaGene+

MelaGene+

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 65-year-old males or females

You may not qualify if:

• 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

Sponsors & Collaborators

• TCI Co., Ltd.: lead

Study Sites (1)

China Medical University

Taichung, Taiwan

Location

Study Officials

• Jing-Ling Li

  China Medical University, China

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 14, 2023
• Study Start: September 1, 2022
• Primary Completion: November 30, 2022
• Study Completion: May 31, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

TW (1)