Anti-aging and Anti-oxidant Efficacy Evaluation of the MelaGene

Not Applicable

Completed

• Conditions: Aging; Antioxidative Stress
• Interventions: Dietary Supplement: Placebo drink; Dietary Supplement: MelaGene drink

• Registration Number: NCT05191056
• Lead Sponsor: TCI Co., Ltd.

Brief Summary

The primary purpose of the present study is to evaluate the effects of MelaGene on anti-aging and anti-oxidant.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-15
• Study First Submitted: 2022-01-04
• Study First Submitted QC: 2022-01-04
• Primary Completion: 2022-01-10
• Study First Posted: 2022-01-13
• Study Completion: 2022-02-28
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• 30 to 65-year-old;
• Must read and sign the informed consent form before the experiment;
• People who are willing to cooperate with contraception during the trial period;
• Do not change lifestyle and eating habits arbitrarily during the trial period;
• Do not take supplementary foods and health supplements with the same efficacy two weeks before and during the test;
• If any adverse reaction occurs during the experiment, subjects should be notified the researcher immediately.

Exclusion Criteria

• Subject who is not willing to participate in this study;
• Vegetarians;
• People with a history of organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine diseases, mental illness, alcohol or drug abuse, and other major organic diseases (according to medical history);
• Participate in other clinical trials related to antioxidants and anti-aging four weeks before and during the test;
• People with a history of dyspepsia would affect the absorption of the test product;
• Allergic to the components of the test product;
• Pregnant or breast-feeding women;
• Take anti-oxidant supplements;
• Undergoing hormone replacement therapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo drink	Placebo drink	-
MelaGene drink	MelaGene drink	-

Primary Outcome Measures

Name	Time	Method
The change of blood lipid (Triglyceride, total cholestrol, HDL-C, LDL-C)	Days 1, 28, and 56	Venous blood is sampled to measure concentrations of blood lipid (Triglyceride, total cholestrol, HDL-C, LDL-C)
The change of ALT and AST	Days 1, 28, and 56	Venous blood is sampled to measure concentrations of ALT and AST
The change of MDA	Days 1, 28, and 56	Venous blood is sampled to measure concentrations of MDA
The change of blood antioxidants(f-Thiols, t-GSH, GST-RBC, SOD, Total Anit-oxidative Capicity)	Days 1, 28, and 56	Venous blood is sampled to measure concentrations of blood antioxidants(f-Thiols, t-GSH, GST-RBC, SOD, Total Anit-oxidative Capicity)
The change of anti-aging gene expression	Days 1, 28, and 56	Venous blood is sampled to measure expression of anti-aging gene
The change of cardiovascular endurance	Days 1, 28, and 56	Step test is designed to assess cardiovascular endurance

Secondary Outcome Measures

Name	Time	Method
The change of fatigue condition	Days 1, 28, and 56	BFI-Taiwan Form is collected to assess fatigue condition
The change of continuous attention test	Days 1, 28, and 56	Continuous attention test is designed to assess cognitive performance

Trial Locations

Locations (1)

Bo Han Wu; 🇨🇳 Pingtung, Taiwan