Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-01 @ 8:27 PM
Study NCT ID:
NCT05620667
Status:
UNKNOWN
Last Update Posted:
2022-11-17
First Post:
2022-11-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Citrus Reticulate Unripe Fruit Extraction on Body Weight and Body Fat.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-10', 'studyFirstSubmitDate': '2022-11-10', 'studyFirstSubmitQcDate': '2022-11-10', 'lastUpdatePostDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline body weight at week 8', 'timeFrame': 'Week 0, Week 8', 'description': 'Compared the difference of body weight between the week 8 and 0.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline body fat at week 8', 'timeFrame': 'Week 0, Week 8', 'description': 'Compared the difference of body fat between the week 8 and 0.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight and Obesity']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effects of immature ponkan (Citrus reticulate) extract on body weight and body fat in overweight and obese adults.', 'detailedDescription': 'This randomized, placebo-controlled clinical trial will be conduct for 8 weeks with three hundred adults. Subjects will be recruited and randomly assigned into three groups: (1) placebo, n = 100; (2) immature ponkan extract, n=100; (3) immature ponkan extract with time restricted feeding, n=100. During the 8 weeks intervention, the subjects should take 25mL liquid of placebo or immature ponkan extract a day (drink 25mL for once, and once a day). The two drinks are supplied in aluminum foil packages, and both the products taste the same. Subjects also should complete the assessment of anthropometric measurement, intestinal questionnaire , food record, feces and blood collection at week 0, 4 and week 8.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male or female\n* aged 20-60 years old\n* body mass index is greater than or equal to 24 kg/m2, or body fat more than 30%\n\nExclusion Criteria:\n\n* Subjects diagnosed with cancer and on curative care.\n* Subjects diagnosed with heart disease and on curative care.\n* Subjects who use other drugs whose pharmacological effects may affect the experiment or may aggravate the effects of the drug.\n* Subjects with systemic infection requiring antibiotics.'}, 'identificationModule': {'nctId': 'NCT05620667', 'briefTitle': 'Effects of Citrus Reticulate Unripe Fruit Extraction on Body Weight and Body Fat.', 'organization': {'class': 'OTHER', 'fullName': 'Chung Shan Medical University'}, 'officialTitle': 'Effects of Citrus Reticulate Unripe Fruit Extraction on Body Weight and Body Fat in Human Trial.', 'orgStudyIdInfo': {'id': 'CS2-22066'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Placebo 25mL, without any ingredients of immature ponkan extract. Drink 25mL for once, and once a day.', 'interventionNames': ['Dietary Supplement: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'immature ponkan (Citrus reticulate) extract', 'description': 'Immature ponkan (Citrus reticulate) extract 25 mL, drink 25mL for once, and once a day.', 'interventionNames': ['Dietary Supplement: immature ponkan (Citrus reticulate) extract']}, {'type': 'EXPERIMENTAL', 'label': 'immature ponkan (Citrus reticulate) extract with time restricted feeding', 'description': 'Immature ponkan (Citrus reticulate) extract 25 mL, drink 25mL for once, and once a day, adding time restricted feeding.', 'interventionNames': ['Dietary Supplement: immature ponkan (Citrus reticulate) extract', 'Behavioral: time restricted feeding']}], 'interventions': [{'name': 'immature ponkan (Citrus reticulate) extract', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Drink 25mL for once, and once a day.', 'armGroupLabels': ['immature ponkan (Citrus reticulate) extract', 'immature ponkan (Citrus reticulate) extract with time restricted feeding']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Drink 25mL for once, and once a day.', 'armGroupLabels': ['placebo']}, {'name': 'time restricted feeding', 'type': 'BEHAVIORAL', 'description': 'Controlling a shortened period of time for eating within 8 hour each day.', 'armGroupLabels': ['immature ponkan (Citrus reticulate) extract with time restricted feeding']}]}, 'contactsLocationsModule': {'locations': [{'zip': '402', 'city': 'Taichung', 'state': 'South', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chin-Lin Hsu, Professor', 'role': 'CONTACT', 'email': 'clhsu@csmu.edu.tw', 'phone': '04-24730022', 'phoneExt': '12222'}], 'facility': 'Chung Shan Medical University', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Chin-Lin Hsu, Professor', 'role': 'CONTACT', 'email': 'clhsu@csmu.edu.tw', 'phone': '04-24730022', 'phoneExt': '12222'}], 'overallOfficials': [{'name': 'Yu-Jou Chien, PhD student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chung Shan Medical University'}, {'name': 'Ying-Ching Feng, MS student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chung Shan Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chung Shan Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'TCI Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Chin-Lin Hsu', 'investigatorAffiliation': 'Chung Shan Medical University'}}}}