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Completed

NCT Number: NCT05191056

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.

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Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bo Han Wu

Pingtung City, 912, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo drink

Dietary Supplement

consume 1 bottle per day for 8 weeks

MelaGene drink

Dietary Supplement

consume 1 bottle per day for 8 weeks

Primary outcomes

  1. The change of blood lipid (Triglyceride, total cholestrol, HDL-C, LDL-C)

    Time frame: 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

    Time frame: Days 1, 28, and 56

    Venous blood is sampled to measure concentrations of ALT and AST

  3. The change of MDA

    Time frame: 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)

    Time frame: 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

    Time frame: Days 1, 28, and 56

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

  6. The change of cardiovascular endurance

    Time frame: Days 1, 28, and 56

    Step test is designed to assess cardiovascular endurance

Secondary outcomes

  1. The change of continuous attention test

    Time frame: Days 1, 28, and 56

    Continuous attention test is designed to assess cognitive performance

  2. The change of fatigue condition

    Time frame: Days 1, 28, and 56

    BFI-Taiwan Form is collected to assess fatigue condition

Sponsors and collaborators

Lead sponsor

TCI Co., Ltd.

Industry

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 13, 2022
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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