Evaluation of the Sleep-relieving Effect of Banana Peel Extract

Not Applicable

Active, not recruiting

• Conditions: Impaired Attention
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Banana peel extract

• Registration Number: NCT05130359
• Lead Sponsor: TCI Co., Ltd.

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.

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 Timeline

• Study First Submitted: 2021-10-21
• Study First Submitted QC: 2021-11-11
• Study First Posted: 2021-11-23
• Study Start: 2022-09-01
• Primary Completion: 2024-05-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-11
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	consume 2 tablets per day for 4 weeks
Banana peel extract	Banana peel extract	consume 2 tablets per day for 4 weeks

Primary Outcome Measures

Name	Time	Method
Sleep monitoring	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	at 4 week after taking test sample	Venous blood was sampled to measure concentrations of Serotonin
Melatonin	at 4 week after taking test sample	Collect saliva samples in the morning upon waking to measure melatonin concentration.
Sleeping quality	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	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.

Trial Locations

Locations (1)

Taipei Medical University; 🇨🇳 Taipei, Taiwan