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

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

Study Overview

• Status: Completed
• Conditions: Aging; Antioxidative Stress
• Intervention / Treatment: Dietary supplement: Placebo drink; Dietary supplement: MelaGene drink

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Pingtung, Taiwan, 912
    • Bo Han Wu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo drink	Dietary supplement: Placebo drink; consume 1 bottle per day for 8 weeks
EXPERIMENTAL: MelaGene drink	Dietary supplement: MelaGene drink; consume 1 bottle per day for 8 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: TCI Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 15, 2021
• Primary Completion (ACTUAL): January 10, 2022
• Study Completion (ACTUAL): February 28, 2022

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (ACTUAL): January 13, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: TSMH IRB No. 21-057-A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No