Impaired AttentionNCT05130359
Evaluation of the Sleep-relieving Effect of Banana Peel Extract
A study testing Banana peel extract in people with Impaired Attention, run by TCI Co., Ltd. at 1 site in Taiwan.
Trial summary
Banana peel has the potential to improve sleep quality. The purpose of this research is to test the effect of banana peel on improving sleep quality. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Impaired Attention
- What is being tested?
- Banana peel extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2022to 31 May 2025
- 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
- 1.20 to 65-year-old males or non-pregnant females who are willing to sign the subject's consent.
- 2.Pittsburgh Sleep Quality Index (PSQI) score> 5
Who cannot join
- Taking sleeping pills and melatonin
- People suffering from mental illness
- Pregnant or breastfeeding women
- People who are known to be allergic to bananas
- Have heart-related diseases
- People with symptoms of sleep cessation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Explore Whether Banana Peel Extract Can Improve Sleep
Banana peel has the potential to improve sleep quality. The purpose of this research is to test the effect of banana peel on improving sleep quality.
Read the detailed description
Insomnia is one of the most frequently complained sleep problems in sleep disorders, and in recent years has been regarded by the medical community as a disease that seriously affects people's lives and quality of life. The problem of perishable and perishable causes a great burden on the environment. However, banana peels actually contain many functional ingredients, such as dietary fiber, minerals, alkaloids, flavonoids, phenols, saponins, tannins and dopamine, etc. Banana peel contains more total phenols and total flavonoids than banana pulp. Studies have pointed out that banana peel extraction can inhibit the growth of fungi and bacteria. In addition, it also has antioxidant, anti-depressant, and diuretic functions. Banana peel can also improve the performance of tryptophan metabolism-related genes
- Conditions
- Impaired Attention
- Being tested
- Placebo, Banana peel extract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
take 2 tablets 2 hours before bedtime for 4 consecutive weeks
Banana peel extractDietary supplement
Also called Happy Banana
take 2 tablets 2 hours before bedtime for 4 consecutive weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | take 2 tablets 2 hours before bedtime for 4 consecutive weeks Receives: Dietary Supplement: Placebo |
| Banana peel extract | Experimental | take 2 tablets 2 hours before bedtime for 4 consecutive weeks Receives: Dietary Supplement: Banana peel extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep monitoring
Detect the electrical activity of the heart in the potential difference between two specific points on the body surface to reflect the state of sleep
Measured: at 4 week after taking test sample
Serotonin
Venous blood was sampled to measure concentrations of Serotonin
Measured: at 4 week after taking test sample
Melatonin
Collect saliva samples in the morning upon waking to measure melatonin concentration.
Measured: at 4 week after taking test sample
Sleeping quality
The Pittsburgh Sleep Quality Index (PSQI) will be utilized to assess sleeping quality. The minimum value is 0, the maximum value is 42. The higher the score, the worse the outcome.
Measured: at 4 week after taking test sample
Insomnia Severity
The Insomnia Severity Index (ISI) will be utilized to assess insomnia severity. The minimum value is 0, the maximum value is 28. The higher the score, the worse the outcome.
Measured: at 4 week after taking test sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start1 Sep 2022
- Primary completion31 May 2024
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired AttentionStudies 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCI Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hsin-Chien Lee, Doctor, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130359
- Sponsor's protocol ID
- N202103033
- Status last verified
- Jul 2025
- First submitted
- 21 Oct 2021
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore Whether Banana Peel Extract Can Improve Sleep
- ClinicalTrials.gov ID
- NCT05130359
- Acronym / sponsor ID
- N202103033
- Conditions
- Impaired Attention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- TCI Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 23 Nov 2021 (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.
Banana peel has the potential to improve sleep quality. The purpose of this research is to test the effect of banana peel on improving sleep quality.
Detailed description
Insomnia is one of the most frequently complained sleep problems in sleep disorders, and in recent years has been regarded by the medical community as a disease that seriously affects people's lives and quality of life. The problem of perishable and perishable causes a great burden on the environment. However, banana peels actually contain many functional ingredients, such as dietary fiber, minerals, alkaloids, flavonoids, phenols, saponins, tannins and dopamine, etc. Banana peel contains more total phenols and total flavonoids than banana pulp. Studies have pointed out that banana peel extraction can inhibit the growth of fungi and bacteria. In addition, it also has antioxidant, anti-depressant, and diuretic functions. Banana peel can also improve the performance of tryptophan metabolism-related genes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebotake 2 tablets 2 hours before bedtime for 4 consecutive weeks |
| Banana peel extract | Experimental | Dietary Supplement: Banana peel extracttake 2 tablets 2 hours before bedtime for 4 consecutive weeks |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1.20 to 65-year-old males or non-pregnant females who are willing to sign the subject's consent.
- 2.Pittsburgh Sleep Quality Index (PSQI) score> 5
Key exclusion criteria (6 listed)
- Taking sleeping pills and melatonin
- People suffering from mental illness
- Pregnant or breastfeeding women
- People who are known to be allergic to bananas
- Have heart-related diseases
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 |
|---|---|---|
| Placebotake 2 tablets 2 hours before bedtime for 4 consecutive weeks | Dietary supplement | Placebo |
| Banana peel extractAlso: Happy Bananatake 2 tablets 2 hours before bedtime for 4 consecutive weeks | Dietary supplement | Banana peel extract |
Primary outcome
Sleep monitoring
Time frame: at 4 week after taking test sample
Detect the electrical activity of the heart in the potential difference between two specific points on the body surface to reflect the state of sleep
Serotonin
Time frame: at 4 week after taking test sample
Venous blood was sampled to measure concentrations of Serotonin
Melatonin
Time frame: at 4 week after taking test sample
Collect saliva samples in the morning upon waking to measure melatonin concentration.
Sleeping quality
Time frame: at 4 week after taking test sample
The Pittsburgh Sleep Quality Index (PSQI) will be utilized to assess sleeping quality. The minimum value is 0, the maximum value is 42. The higher the score, the worse the outcome.
Insomnia Severity
Time frame: at 4 week after taking test sample
The Insomnia Severity Index (ISI) will be utilized to assess insomnia severity. The minimum value is 0, the maximum value is 28. The higher the score, the worse the outcome.
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 30 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Hsin-Chien Lee, Doctor principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Banana peel extract in people with Impaired Attention, 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 2 inclusion and 6 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 30 Jul 2025. 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?
Sleep monitoring (time frame: at 4 week after taking test sample). The study lists 5 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 30 Jul 2025.