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OpenTrials
Completed

NCT Number: NCT05130359

Evaluation of the Sleep-relieving Effect of Banana Peel Extract

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.

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Key information

Conditions

Impaired Attention

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University

Taipei, Taiwan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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

  • 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

Treatment and study plan

Placebo

Dietary Supplement

take 2 tablets 2 hours before bedtime for 4 consecutive weeks

Banana peel extract

Dietary Supplement

take 2 tablets 2 hours before bedtime for 4 consecutive weeks

Other names: Happy Banana

Primary outcomes

  1. 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

  2. Serotonin

    Time frame: at 4 week after taking test sample

    Venous blood was sampled to measure concentrations of Serotonin

  3. Melatonin

    Time frame: at 4 week after taking test sample

    Collect saliva samples in the morning upon waking to measure melatonin concentration.

  4. 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.

  5. 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.

Other outcomes

  1. The change of liver function biomarkers (AST, ALT) of blood

    Time frame: at 4 week after taking test sample

    Fasting venous blood was sampled to measure liver function biomarkers

  2. The change of renal function biomarkers (creatinine, BUN) of blood

    Time frame: at 4 week after taking test sample

    Fasting venous blood was sampled to measure renal function biomarkers

  3. The change of fasting blood glucose

    Time frame: at 4 week after taking test sample

    Fasting venous blood was sampled to measure concentrations of blood glucose

  4. The change of Blood lipids profiles (Total-Cholesterol, HDL-C, LDL-C, triglycerides)

    Time frame: at 4 week after taking test sample

    Fasting venous blood was sampled to measure concentrations of Blood lipids profiles (Total-Cholesterol, HDL-C, LDL-C, triglycerides)

Sponsors and collaborators

Lead sponsor

TCI Co., Ltd.

Industry

Registry information

Official study title

Explore Whether Banana Peel Extract Can Improve Sleep

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Nov 23, 2021
Registry last updated
Jul 30, 2025

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.