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

NCT ID: NCT05191056

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-15
• Study Completion Date: 2022-02-28

Brief Summary

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

Conditions

Aging; Antioxidative Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo drink

Group Type: PLACEBO_COMPARATOR

Placebo drink

Intervention Type: DIETARY_SUPPLEMENT

consume 1 bottle per day for 8 weeks

MelaGene drink

Group Type: EXPERIMENTAL

MelaGene drink

Intervention Type: DIETARY_SUPPLEMENT

consume 1 bottle per day for 8 weeks

Interventions

Placebo drink

consume 1 bottle per day for 8 weeks

Intervention Type: DIETARY_SUPPLEMENT

MelaGene drink

consume 1 bottle per day for 8 weeks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

TCI Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bo han Wu, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Pingtung University of Science and Technology

Locations

Bo Han Wu

Pingtung City, , Taiwan

Countries

Taiwan

Other Identifiers

TSMH IRB No. 21-057-A

Identifier Type: -

Identifier Source: org_study_id