AgingNCT05191056
Anti-aging and Anti-oxidant Efficacy Evaluation of the MelaGene
A study testing MelaGene drink in people with Aging and Antioxidative Stress, run by TCI Co., Ltd. at 1 site in Taiwan.
Trial summary
The primary purpose of the present study is to evaluate the effects of MelaGene on anti-aging and anti-oxidant. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Antioxidative Stress
- What is being tested?
- MelaGene drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Sep 2021to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- Pregnant or breast-feeding women;
- Take anti-oxidant supplements;
- Undergoing hormone replacement therapy.
Trial locations and contacts
1 site in 1 country.
About this study
The primary purpose of the present study is to evaluate the effects of MelaGene on anti-aging and anti-oxidant.
- Conditions
- Aging, Antioxidative Stress
- Being tested
- Placebo drink, MelaGene drink
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo drinkDietary supplement
consume 1 bottle per day for 8 weeks
MelaGene drinkDietary supplement
consume 1 bottle per day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo drink | Placebo comparator | Not described Receives: Dietary Supplement: Placebo drink |
| MelaGene drink | Experimental | Not described Receives: Dietary Supplement: MelaGene drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Days 1, 28, and 56
The change of ALT and AST
Venous blood is sampled to measure concentrations of ALT and AST
Measured: Days 1, 28, and 56
The change of MDA
Venous blood is sampled to measure concentrations of MDA
Measured: 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)
Measured: Days 1, 28, and 56
The change of anti-aging gene expression
Venous blood is sampled to measure expression of anti-aging gene
Measured: Days 1, 28, and 56
The change of cardiovascular endurance
Step test is designed to assess cardiovascular endurance
Measured: Days 1, 28, and 56
Secondary outcomes (2)
The change of continuous attention test
Continuous attention test is designed to assess cognitive performance
Measured: Days 1, 28, and 56
The change of fatigue condition
BFI-Taiwan Form is collected to assess fatigue condition
Measured: Days 1, 28, and 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start15 Sep 2021
- Primary completion10 Jan 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCI Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bo han Wu, Ph.D, Principal investigator, Pingtung University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191056
- Sponsor's protocol ID
- TSMH IRB No. 21-057-A
- Status last verified
- Mar 2022
- First submitted
- 4 Jan 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-aging and Anti-oxidant Efficacy Evaluation of the MelaGene
- ClinicalTrials.gov ID
- NCT05191056
- Acronym / sponsor ID
- TSMH IRB No. 21-057-A
- Conditions
- Aging, Antioxidative Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- TCI Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 13 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of the present study is to evaluate the effects of MelaGene on anti-aging and anti-oxidant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo drink | Placebo comparator | Dietary Supplement: Placebo drink |
| MelaGene drink | Experimental | Dietary Supplement: MelaGene drink |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo drinkconsume 1 bottle per day for 8 weeks | Dietary supplement | Placebo drink |
| MelaGene drinkconsume 1 bottle per day for 8 weeks | Dietary supplement | MelaGene drink |
Primary outcome
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)
The change of ALT and AST
Time frame: Days 1, 28, and 56
Venous blood is sampled to measure concentrations of ALT and AST
The change of MDA
Time frame: Days 1, 28, and 56
Venous blood is sampled to measure concentrations of MDA
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)
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
The change of cardiovascular endurance
Time frame: Days 1, 28, and 56
Step test is designed to assess cardiovascular endurance
2 secondary outcomes
The change of continuous attention test
Time frame: Days 1, 28, and 56
The change of fatigue condition
Time frame: Days 1, 28, and 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo han Wu, Ph.D principal investigator
Pingtung University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MelaGene drink in people with Aging and Antioxidative Stress, run by TCI Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of blood lipid (Triglyceride, total cholestrol, HDL-C, LDL-C) (time frame: Days 1, 28, and 56). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.