Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT06091033
Status:
COMPLETED
Last Update Posted:
2024-04-09
First Post:
2023-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Perceived Stress and Black Rice (Oryza Sativa L.) Extract Fermented With Lactobacillus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-07', 'studyFirstSubmitDate': '2023-10-13', 'studyFirstSubmitQcDate': '2023-10-18', 'lastUpdatePostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'stress response inventory (SRI)', 'timeFrame': '8 weeks', 'description': 'using SRI score. The minimum score was 0, and the maximum score was 195; higher scores mean a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'perceived stress scale (PSS)', 'timeFrame': '8 weeks', 'description': 'using PSS score. The minimum score was 0, and the maximum score was 40; higher scores mean a worse outcome.'}, {'measure': 'stress-Visual Analog Scale (VAS)', 'timeFrame': '8 weeks', 'description': 'using stress-VAS score. The minimum score was 0, and the maximum score was 100; higher scores mean a worse outcome.'}, {'measure': 'EuroQol (EQ)-5D-5L', 'timeFrame': '8 weeks', 'description': 'using stress-VAS score. The minimum score was 0, and the maximum score was 1; higher scores mean a worse outcome.'}, {'measure': 'Salivary cortisol (ng/dl)', 'timeFrame': '8 weeks', 'description': 'Change during 8 weeks'}, {'measure': 'Plasma cortisol (ng/dl)', 'timeFrame': '8 weeks', 'description': 'Change during 8 weeks'}, {'measure': 'Plasma serotonin (nmol/L)', 'timeFrame': '8 weeks', 'description': 'Change during 8 weeks'}, {'measure': 'Plasma dehydroepiandrosterone sulfate (µg/dL)', 'timeFrame': '8 weeks', 'description': 'Change during 8 weeks'}, {'measure': 'Plasma cortisol/dehydroepiandrosterone sulfate ratio', 'timeFrame': '8 weeks', 'description': 'Change during 8 weeks'}, {'measure': 'Plasma adrenocorticotropic hormone (pg/mL)', 'timeFrame': '8 weeks', 'description': 'Change during 8 weeks'}, {'measure': 'Fasting glucose (mg/dL)', 'timeFrame': '8 weeks', 'description': 'Change during 8 weeks'}, {'measure': 'Lactate (mmol/L)', 'timeFrame': '8 weeks', 'description': 'Change during 8 weeks'}, {'measure': 'Free fatty acid (µmol/L)', 'timeFrame': '8 weeks', 'description': 'Change during 8 weeks'}, {'measure': 'Heart rate (beats per minute)', 'timeFrame': '8 weeks', 'description': 'Change during 8 weeks'}, {'measure': 'Systolic blood pressure (BP) (mmHg)', 'timeFrame': '8 weeks', 'description': 'Change during 8 weeks'}, {'measure': 'Diastolic BP(mmHg)', 'timeFrame': '8 weeks', 'description': 'Change during 8 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Perceived Stress']}, 'descriptionModule': {'briefSummary': 'The investigators will conduct a randomized, double-blind, placebo-controlled study to investigate the effects and tolerability of black rice (Oryza Sativa L.) extract fermented with Lactobacillus on patients with perceived stress for 8 weeks.', 'detailedDescription': 'A previous animal study has indicated that black rice (Oryza Sativa L.) extract fermented with Lactobacillus relieved stressful situations in a 7-week-old C57BL/6 mice model. Therefore, the investigators will conduct a randomized, double-blind, placebo-controlled study to investigate the effects and tolerability of black rice (Oryza Sativa L.) extract fermented with Lactobacillus on patients with perceived stress for 8 weeks; the safety of the compound is also evaluated. The Investigators examine stress response inventory (SRI), perceived stress scale (PSS), stress-visual analog scale (VAS), EQ-5D-5L, salivary cortisol, plasma cortisol, serotonin, dehydroepiandrosterone sulfate (DHEAS), cortisol/DHEAS ratio, adrenocorticotropic hormone (ACTH), glucose, lactate, free fatty acid (FFA), malondialdehyde (MDA) superoxide dismutase (SOD), heart rate, systolic blood pressure (BP), and diastolic BP at baseline and after 8 weeks of intervention. Eighty adults were administered either 1,000 mg of black rice (Oryza Sativa L.) extract fermented with Lactobacillus or a placebo each day for 8 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- the Perceived Stress Scale between 13-18\n\nExclusion Criteria:\n\n* People with alcohol use/induced disorders\n* Persons with brain disease or undergoing rehabilitation treatment for brain disease\n* Patients with mental illnesses such as major affective disorder, post-traumatic stress disorder, uncontrolled obsessive-compulsive disorder, schizophrenia, dementia, drug addiction, etc.\n* Those who have taken psychotropic drugs, sleeping pills, appetite suppressants, oral steroids, and corticosteroids within 1 month before starting the trial\n* Those who have taken functional health foods recognized by the Ministry of Food and Drug Safety related to relieving tension caused by stress and improving sleep within 1 month before the start of the test\n* Those who show withdrawal symptoms due to abstinence from drinking or smoking within 1 month before starting the trial.'}, 'identificationModule': {'nctId': 'NCT06091033', 'briefTitle': 'Perceived Stress and Black Rice (Oryza Sativa L.) Extract Fermented With Lactobacillus', 'organization': {'class': 'OTHER', 'fullName': 'Pusan National University Yangsan Hospital'}, 'officialTitle': 'Perceived Stress and Black Rice (Oryza Sativa L.) Extract Fermented With Lactobacillus: a Double-blind, Randomized, Placebo-controlled Study', 'orgStudyIdInfo': {'id': 'IRB 02-2021-041'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fermented rice group', 'description': 'This group takes black rice (Oryza Sativa L.) extract fermented with Lactobacillus for 8 weeks.', 'interventionNames': ['Dietary Supplement: Fermented rice']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'This group takes a placebo for 8 weeks.', 'interventionNames': ['Dietary Supplement: placebo']}], 'interventions': [{'name': 'Fermented rice', 'type': 'DIETARY_SUPPLEMENT', 'description': '1,000 mg of black rice (Oryza Sativa L.) extract fermented with Lactobacillus for 8 weeks', 'armGroupLabels': ['Fermented rice group']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '1,000 mg of a placebo for 8 weeks', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50612', 'city': 'Yangsan', 'state': 'Gyeungsangnam-do', 'country': 'South Korea', 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}], 'overallOfficials': [{'name': 'Sang Yeoup Lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pusan National University Yangsan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pusan National University Yangsan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sang Yeoup Lee', 'investigatorAffiliation': 'Pusan National University Yangsan Hospital'}}}}