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Evaluation of the Sleep-relieving Effect of Banana Peel Extract

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05130359
Recruitment Status : Recruiting
First Posted : November 23, 2021
Last Update Posted : September 29, 2022
Sponsor:
Information provided by (Responsible Party):
TCI Co., Ltd.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Impaired Attention Dietary Supplement: Placebo Dietary Supplement: Banana peel extract Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Explore Whether Banana Peel Extract Can Improve Sleep
Actual Study Start Date : September 1, 2022
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : January 16, 2023
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
consume 2 sachet per day for 4 weeks
 Dietary Supplement: Placebo
consume 2 sachet per day for 4 weeks
Experimental: Banana peel extract
consume 2 sachet per day for 4 weeks
 Dietary Supplement: Banana peel extract
consume 2 sachet per day for 4 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Blood pressure [ Time Frame: at 4 week after taking test sample ]
    Blood pressure measurement via automatic sphygmomanometer

  2. Total-Cholesterol [ Time Frame: at 4 week after taking test sample ]
    Venous blood was sampled to measure concentrations of total-Cholesterol

  3. Triglyceride [ Time Frame: at 4 week after taking test sample ]
    Venous blood was sampled to measure concentrations of triglyceride

  4. HDL-C [ Time Frame: at 4 week after taking test sample ]
    Venous blood was sampled to measure concentrations of HDL-C

  5. LDL-C [ Time Frame: at 4 week after taking test sample ]
    Venous blood was sampled to measure concentrations of LDL-C

  6. 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

  7. Serotonin [ Time Frame: at 4 week after taking test sample ]
    Venous blood was sampled to measure concentrations of Serotonin

  8. Melatonin [ Time Frame: at 4 week after taking test sample ]
    Venous blood was sampled to measure concentrations of Melatonin


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Taking sleeping pills and melatonin
  2. People suffering from mental illness
  3. Pregnant or breastfeeding women
  4. People who are known to be allergic to bananas
  5. Have heart-related diseases
  6. People with symptoms of sleep cessation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05130359


Contacts
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Contact: Chi Fu Chiang, Ph.D 02 8797 7811 Jimmy.Chiang@tci-bio.com

Locations
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Taiwan
Taipei Medical University Recruiting
Taipei, Taiwan
Contact: Hsin-Chien Lee         
Sponsors and Collaborators
TCI Co., Ltd.
Investigators
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Principal Investigator: Hsin-Chien Lee, Doctor Taipei Medical University
More Information
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Responsible Party: TCI Co., Ltd.
ClinicalTrials.gov Identifier: NCT05130359    
Other Study ID Numbers: N202103033
First Posted: November 23, 2021    Key Record Dates
Last Update Posted: September 29, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No