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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05191056
• Other study ID #: TSMH IRB No. 21-057-A
• Status: Completed
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: March 2022
• Source: TCI Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: February 28, 2022
• Est. primary completion date: January 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging

Intervention

Dietary Supplement:
• Placebo drink
consume 1 bottle per day for 8 weeks
• MelaGene drink
consume 1 bottle per day for 8 weeks

Locations

Country	Name	City	State
Taiwan	Bo Han Wu	Pingtung

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 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
Primary	The change of ALT and AST	Venous blood is sampled to measure concentrations of ALT and AST	Days 1, 28, and 56
Primary	The change of MDA	Venous blood is sampled to measure concentrations of MDA	Days 1, 28, and 56
Primary	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
Primary	The change of anti-aging gene expression	Venous blood is sampled to measure expression of anti-aging gene	Days 1, 28, and 56
Primary	The change of cardiovascular endurance	Step test is designed to assess cardiovascular endurance	Days 1, 28, and 56
Secondary	The change of continuous attention test	Continuous attention test is designed to assess cognitive performance	Days 1, 28, and 56
Secondary	The change of fatigue condition	BFI-Taiwan Form is collected to assess fatigue condition	Days 1, 28, and 56