Evaluation of the Sleep-relieving Effect of Banana Peel Extract

NCT05130359 | Completed

• 1 other identifier: N202103033
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Impaired Attention

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

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

  at 4 week after taking test sample

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

  at 4 week after taking test sample

• The change of fasting blood glucose

  at 4 week after taking test sample

Study Arms (2)

Placebo

PLACEBO COMPARATOR

take 2 tablets 2 hours before bedtime for 4 consecutive weeks

Dietary Supplement: Placebo

Banana peel extract

EXPERIMENTAL

take 2 tablets 2 hours before bedtime for 4 consecutive weeks

Dietary Supplement: Banana peel extract

Interventions

Placebo DIETARY_SUPPLEMENT

take 2 tablets 2 hours before bedtime for 4 consecutive weeks

Placebo

Banana peel extract DIETARY_SUPPLEMENT

take 2 tablets 2 hours before bedtime for 4 consecutive weeks

Also known as: Happy Banana

Banana peel extract

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 65-year-old males or non-pregnant females who are willing to sign the subject's consent.
• Pittsburgh Sleep Quality Index (PSQI) score\> 5

You may not qualify if:

• 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

Sponsors & Collaborators

• TCI Co., Ltd.: lead

Study Sites (1)

Taipei Medical University

Taipei, Taiwan

Location

Study Officials

• Hsin-Chien Lee, Doctor

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 23, 2021
• Study Start: September 1, 2022
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)