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

Cognitive Change Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05988593
• Other study ID #: CMUH111-REC3-127
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: August 2023
• Source: TCI Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the efficacy of MelaGene+ on cognitive performance

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 31, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Change

Intervention

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

Locations

Country	Name	City	State
Taiwan	China Medical University	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
TCI Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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