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

Not Applicable

Completed

• Conditions: Cognitive Change
• Interventions: Dietary Supplement: MelaGene+; Dietary Supplement: placebo

• Registration Number: NCT05988593
• Lead Sponsor: TCI Co., Ltd.

Brief Summary

To assess the efficacy of MelaGene+ on cognitive performance

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-01
• Primary Completion: 2022-11-30
• Study Completion: 2023-05-31
• Status Verified: 2023-08
• Study First Submitted: 2023-08-04
• Study First Submitted QC: 2023-08-04
• Last Update Submitted: 2023-08-10
• Study First Posted: 2023-08-14
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MelaGene+	MelaGene+	-
placebo drink	placebo	-

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.
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.
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.
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.

Trial Locations

Locations (1)

China Medical University; 🇨🇳 Taichung, Taiwan