Clincosm LogoSign in Get a demo

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

Sponsor
TCI Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT05191056
Collaborator
(none)
51
Enrollment
1
Location
2
Arms
5.5
Actual Duration (Months)
9.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Placebo drink
  • Dietary Supplement: MelaGene drink
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
51 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Anti-aging and Anti-oxidant Efficacy Evaluation of the MelaGene
Actual Study Start Date :
Sep 15, 2021
Actual Primary Completion Date :
Jan 10, 2022
Actual Study Completion Date :
Feb 28, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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)

  2. The change of ALT and AST [Days 1, 28, and 56]

    Venous blood is sampled to measure concentrations of ALT and AST

  3. The change of MDA [Days 1, 28, and 56]

    Venous blood is sampled to measure concentrations of MDA

  4. 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)

  5. The change of anti-aging gene expression [Days 1, 28, and 56]

    Venous blood is sampled to measure expression of anti-aging gene

  6. The change of cardiovascular endurance [Days 1, 28, and 56]

    Step test is designed to assess cardiovascular endurance

Secondary Outcome Measures

  1. The change of continuous attention test [Days 1, 28, and 56]

    Continuous attention test is designed to assess cognitive performance

  2. The change of fatigue condition [Days 1, 28, and 56]

    BFI-Taiwan Form is collected to assess fatigue condition

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bo Han Wu Pingtung Taiwan 912

Sponsors and Collaborators

  • TCI Co., Ltd.

Investigators

  • Principal Investigator: Bo han Wu, Ph.D, Pingtung University of Science and Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
TCI Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05191056
Other Study ID Numbers:
  • TSMH IRB No. 21-057-A
First Posted:
Jan 13, 2022
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 31, 2022