Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-28 @ 4:01 AM
Study NCT ID:
NCT05130359
Status:
COMPLETED
Last Update Posted:
2025-07-30
First Post:
2021-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Sleep-relieving Effect of Banana Peel Extract
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2021-10-21', 'studyFirstSubmitQcDate': '2021-11-11', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The change of liver function biomarkers (AST, ALT) of blood', 'timeFrame': 'at 4 week after taking test sample', 'description': 'Fasting venous blood was sampled to measure liver function biomarkers'}, {'measure': 'The change of renal function biomarkers (creatinine, BUN) of blood', 'timeFrame': 'at 4 week after taking test sample', 'description': 'Fasting venous blood was sampled to measure renal function biomarkers'}, {'measure': 'The change of fasting blood glucose', 'timeFrame': 'at 4 week after taking test sample', 'description': 'Fasting venous blood was sampled to measure concentrations of blood glucose'}, {'measure': 'The change of Blood lipids profiles (Total-Cholesterol, HDL-C, LDL-C, triglycerides)', 'timeFrame': 'at 4 week after taking test sample', 'description': 'Fasting venous blood was sampled to measure concentrations of Blood lipids profiles (Total-Cholesterol, HDL-C, LDL-C, triglycerides)'}], 'primaryOutcomes': [{'measure': 'Sleep monitoring', 'timeFrame': 'at 4 week after taking test sample', 'description': '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'}, {'measure': 'Serotonin', 'timeFrame': 'at 4 week after taking test sample', 'description': 'Venous blood was sampled to measure concentrations of Serotonin'}, {'measure': 'Melatonin', 'timeFrame': 'at 4 week after taking test sample', 'description': 'Collect saliva samples in the morning upon waking to measure melatonin concentration.'}, {'measure': 'Sleeping quality', 'timeFrame': 'at 4 week after taking test sample', 'description': '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.'}, {'measure': 'Insomnia Severity', 'timeFrame': 'at 4 week after taking test sample', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Impaired Attention']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1.20 to 65-year-old males or non-pregnant females who are willing to sign the subject's consent.\n\n2.Pittsburgh Sleep Quality Index (PSQI) score\\> 5\n\nExclusion Criteria:\n\n1. Taking sleeping pills and melatonin\n2. People suffering from mental illness\n3. Pregnant or breastfeeding women\n4. People who are known to be allergic to bananas\n5. Have heart-related diseases\n6. People with symptoms of sleep cessation"}, 'identificationModule': {'nctId': 'NCT05130359', 'briefTitle': 'Evaluation of the Sleep-relieving Effect of Banana Peel Extract', 'organization': {'class': 'INDUSTRY', 'fullName': 'TCI Co., Ltd.'}, 'officialTitle': 'Explore Whether Banana Peel Extract Can Improve Sleep', 'orgStudyIdInfo': {'id': 'N202103033'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'take 2 tablets 2 hours before bedtime for 4 consecutive weeks', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Banana peel extract', 'description': 'take 2 tablets 2 hours before bedtime for 4 consecutive weeks', 'interventionNames': ['Dietary Supplement: Banana peel extract']}], 'interventions': [{'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'take 2 tablets 2 hours before bedtime for 4 consecutive weeks', 'armGroupLabels': ['Placebo']}, {'name': 'Banana peel extract', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Happy Banana'], 'description': 'take 2 tablets 2 hours before bedtime for 4 consecutive weeks', 'armGroupLabels': ['Banana peel extract']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Medical University', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Hsin-Chien Lee, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taipei Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TCI Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}