Cognitive ChangeNCT05988593
Testing the Cognitive Facilitation Effect by Dietary Supplementation of MelaGene+ Drink
A study testing MelaGene+ in people with Cognitive Change, run by TCI Co., Ltd. at 1 site in Taiwan.
Trial summary
To assess the efficacy of MelaGene+ on cognitive performance Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- MelaGene+
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2022to 31 May 2023
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 20 to 65-year-old males or females
Who cannot join
- Participants are breastfeeding, pregnant or planning to become pregnant during the test (self-report)
- Participants with heart, liver, kidney, endocrine and other major organic diseases (self-reported)
- Participants take drugs for a long time (self-report)
- Participants with mental illness or have undergone brain surgery
- Participants still can not clearly see words with 12pt on computer after corrected vision
Trial locations and contacts
1 site in 1 country.
About this study
To assess the efficacy of MelaGene+ on cognitive performance
- Conditions
- Cognitive Change
- Being tested
- placebo, MelaGene+
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDietary supplement
consume one bottle (30 mL) per day
MelaGene+Dietary supplement
Also called Melaleuca-MelaGene+
consume one bottle (30 mL) per day
| Study group | Role | What they receive |
|---|---|---|
| placebo drink | Placebo comparator | Not described Receives: Dietary Supplement: placebo |
| MelaGene+ | Experimental | Not described Receives: Dietary Supplement: MelaGene+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of Match to sample test
The number of memorized cards was utilized to measure Match to sample test value.
Measured: Change from Baseline match to sample test value at 8 weeks
The change of Trail making test
The time of finishing actions was utilized to measure Trail making test value.
Measured: Change from Baseline Trail making test value at 8 weeks
The change of Processing speed test
The number of pressing buttons was utilized to measure Processing speed test value.
Measured: Change from Baseline Processing speed test value at 8 weeks
The change of Mnemonic Similarity Task
The proportion of correction about ability on memorizing old things was utilized to measure Mnemonic Similarity Task value.
Measured: Change from Baseline Mnemonic Similarity Task value at 8 weeks
The change of facial expression cuing task
The correction of evaluation on facial emotion was utilized to measure facial expression cuing task value.
Measured: Change from Baseline facial expression cuing task value at 8 weeks
The change of State-trait anxiety inventory
The scores of anxiety state was utilized to measure State-trait anxiety inventory value.
Measured: Change from Baseline State-trait anxiety inventory value at 8 weeks
The change of score of fatigue
The PSS (The Perceived Stress Scale)-14 questionnaire was utilized to measure fatigue condition.
Measured: Change from Baseline PSS (The Perceived Stress Scale)-14 value at 8 weeks
The change of score of life quality
The WHOQOL-BREF (The World Health Organization Quality of Life Brief Version) questionnaire was utilized to measure life quality.
Measured: Change from Baseline WHOQOL-BREF (The World Health Organization Quality of Life Brief Version) value at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Sep 2022
- Primary completion30 Nov 2022
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCI Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jing-Ling Li, Principal investigator, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988593
- Sponsor's protocol ID
- CMUH111-REC3-127
- Status last verified
- Aug 2023
- First submitted
- 4 Aug 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Cognitive Facilitation Effect by Dietary Supplementation of MelaGene+ Drink
- ClinicalTrials.gov ID
- NCT05988593
- Acronym / sponsor ID
- CMUH111-REC3-127
- Conditions
- Cognitive Change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- TCI Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 14 Aug 2023 (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.
To assess the efficacy of MelaGene+ on cognitive performance
Study design
- Primary purpose
- Other
- 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 |
| MelaGene+ | Experimental | Dietary Supplement: MelaGene+ |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 20 to 65-year-old males or females
Key exclusion criteria (5 listed)
- Participants are breastfeeding, pregnant or planning to become pregnant during the test (self-report)
- Participants with heart, liver, kidney, endocrine and other major organic diseases (self-reported)
- Participants take drugs for a long time (self-report)
- Participants with mental illness or have undergone brain surgery
- Participants still can not clearly see words with 12pt on computer after corrected vision
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 |
|---|---|---|
| placeboconsume one bottle (30 mL) per day | Dietary supplement | placebo drink |
| MelaGene+Also: Melaleuca-MelaGene+consume one bottle (30 mL) per day | Dietary supplement | MelaGene+ |
Primary outcome
The change of Match to sample test
Time frame: Change from Baseline match to sample test value at 8 weeks
The number of memorized cards was utilized to measure Match to sample test value.
The change of Trail making test
Time frame: Change from Baseline Trail making test value at 8 weeks
The time of finishing actions was utilized to measure Trail making test value.
The change of Processing speed test
Time frame: Change from Baseline Processing speed test value at 8 weeks
The number of pressing buttons was utilized to measure Processing speed test value.
The change of Mnemonic Similarity Task
Time frame: Change from Baseline Mnemonic Similarity Task value at 8 weeks
The proportion of correction about ability on memorizing old things was utilized to measure Mnemonic Similarity Task value.
The change of facial expression cuing task
Time frame: Change from Baseline facial expression cuing task value at 8 weeks
The correction of evaluation on facial emotion was utilized to measure facial expression cuing task value.
The change of State-trait anxiety inventory
Time frame: Change from Baseline State-trait anxiety inventory value at 8 weeks
The scores of anxiety state was utilized to measure State-trait anxiety inventory value.
The change of score of fatigue
Time frame: Change from Baseline PSS (The Perceived Stress Scale)-14 value at 8 weeks
The PSS (The Perceived Stress Scale)-14 questionnaire was utilized to measure fatigue condition.
The change of score of life quality
Time frame: Change from Baseline WHOQOL-BREF (The World Health Organization Quality of Life Brief Version) value at 8 weeks
The WHOQOL-BREF (The World Health Organization Quality of Life Brief Version) questionnaire was utilized to measure life quality.
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 14 Aug 2023.
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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.
Jing-Ling Li principal investigator
China Medical University, China
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+ in people with Cognitive Change, 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 1 inclusion and 5 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 14 Aug 2023. 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 Match to sample test (time frame: Change from Baseline match to sample test value at 8 weeks). The study lists 8 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 14 Aug 2023.