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

NCT05191056 | Completed

• 1 other identifier: TSMH IRB No. 21-057-A
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• The change of continuous attention test

  Days 1, 28, and 56

• The change of fatigue condition

  Days 1, 28, and 56

Study Arms (2)

Placebo drink

PLACEBO COMPARATOR

Dietary Supplement: Placebo drink

MelaGene drink

EXPERIMENTAL

Dietary Supplement: MelaGene drink

Interventions

Placebo drink DIETARY_SUPPLEMENT

consume 1 bottle per day for 8 weeks

Placebo drink

MelaGene drink DIETARY_SUPPLEMENT

consume 1 bottle per day for 8 weeks

MelaGene drink

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TCI Co., Ltd.: lead

Study Sites (1)

Bo Han Wu

Pingtung City, 912, Taiwan

Location

Study Officials

• Bo han Wu, Ph.D

  Pingtung University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 13, 2022
• Study Start: September 15, 2021
• Primary Completion: January 10, 2022
• Study Completion: February 28, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

TW (1)