Evaluation of the Sleep-relieving Effect of Banana Peel Extract

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.

Study Overview

• Status: Completed
• Conditions: Impaired Attention
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Banana peel extract

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Taipei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; take 2 tablets 2 hours before bedtime for 4 consecutive weeks	Dietary supplement: Placebo; take 2 tablets 2 hours before bedtime for 4 consecutive weeks
Experimental: Banana peel extract; take 2 tablets 2 hours before bedtime for 4 consecutive weeks	Dietary supplement: Banana peel extract; take 2 tablets 2 hours before bedtime for 4 consecutive weeks; Other Names: Happy Banana

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at 4 week after taking test sample
Serotonin	Venous blood was sampled to measure concentrations of Serotonin	at 4 week after taking test sample
Melatonin	Collect saliva samples in the morning upon waking to measure melatonin concentration.	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.	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.	at 4 week after taking test sample

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of liver function biomarkers (AST, ALT) of blood	Fasting venous blood was sampled to measure liver function biomarkers	at 4 week after taking test sample
The change of renal function biomarkers (creatinine, BUN) of blood	Fasting venous blood was sampled to measure renal function biomarkers	at 4 week after taking test sample
The change of fasting blood glucose	Fasting venous blood was sampled to measure concentrations of blood glucose	at 4 week after taking test sample
The change of Blood lipids profiles (Total-Cholesterol, HDL-C, LDL-C, triglycerides)	Fasting venous blood was sampled to measure concentrations of Blood lipids profiles (Total-Cholesterol, HDL-C, LDL-C, triglycerides)	at 4 week after taking test sample

Collaborators and Investigators

• Sponsor: TCI Co., Ltd.
• Investigators: Principal Investigator: Hsin-Chien Lee, Doctor, Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): May 31, 2024
• Study Completion (Actual): May 31, 2025

Study Registration Dates

• First Submitted: October 21, 2021
• First Submitted That Met QC Criteria: November 11, 2021
• First Posted (Actual): November 23, 2021

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: N202103033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No