Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-25 @ 8:11 PM
Study NCT ID:
NCT07239635
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2025-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Perch Essence on Cognitive Function Status in Subjects With Mild Cognitive Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2025-11-13', 'studyFirstSubmitQcDate': '2025-11-18', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive Abilities Screening Instrument (CASI)', 'timeFrame': 'Week 0, 12, and 24', 'description': 'Cognitive assessments, ranges from 0 to 100, with higher scores indicating better cognitive function, lower than 74 may indicate cognitive impairment, and scores are also affected by age and education level.'}, {'measure': 'Montreal Cognitive Assessment', 'timeFrame': 'Week 0, 12, and 24', 'description': 'Cognitive assessments, 30 score as full, scoring ≥26 considered as normal, below 26 may indicate impairment, with a score of 18-25 suggesting mild impairment, 10-17 moderate impairment, and below 10 indicating severe impairment.'}], 'secondaryOutcomes': [{'measure': 'Anthropometric data', 'timeFrame': 'Week 0, 12, and 24', 'description': 'Weight and height will be combined to calculate BMI (kg/m2)'}, {'measure': 'Blood biochemistry: Nutritional status', 'timeFrame': 'Week 0, 12, and 24', 'description': 'Albumin, total protein, Vitamin B12, folate, magnesium'}, {'measure': 'Blood biochemistry: Glycemic profiles', 'timeFrame': 'Week 0, 12, and 24', 'description': 'fasting blood glucose'}, {'measure': 'Blood biochemistry: Lipid profiles', 'timeFrame': 'Week 0, 12, and 24', 'description': 'total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), triglycerides (TG)'}, {'measure': 'Blood biochemistry: Complete blood counts', 'timeFrame': 'Week 0, 12, and 24', 'description': 'white blood cells (WBC), red blood cells (RBC), hemoglobin (HB), platelet count (PLT), hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC)'}, {'measure': 'Blood biochemistry: BDNF and oxidative stress', 'timeFrame': 'Week 0, 12, and 24', 'description': 'Brain derived neurotrophic factor (BDNF), malondialdehyde (MDA)'}, {'measure': 'Nutrition status', 'timeFrame': 'Week 0, 24', 'description': 'Mini-nutritional assessments (MNA): Maximum scores are at 30; scores ≥ 24: not in malnutrition risk; 17-23.5: risk in malnutrition, \\<17: malnutrition.\n\n3-day dietary recall'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mild Cognitive Impairment']}, 'descriptionModule': {'briefSummary': "With global population aging, cognitive impairment and dementia have become major public health issues worldwide. According to the 2019 World Alzheimer Report by the Alzheimer's Disease International, there are more than 50 million people living with dementia globally, and this number is projected to rise to 152 million by 2050, with one new case occurring every three seconds. Our research is to investigate the intervention effects of perch essence on cognitive function in mild-cognitive impairment patients.\n\n1\\. Study population: 54 MCI patients were recruited and the inclusion criteria are: (1) aged ≥ 45, (2) diagnosed with mild cognitive impairment by clinical dementia rating (CDR) with a scoring of 0.5, and (3) have the ability to communicate, reading and writing. The exclusion criteria are: (1) diagnosed with dementia, (2) diagnosed with terminal diseases or severe psychological symptoms (lifespan ≤ 2 years, cancer, severe stroke, heart disease, liver cirrhosis, ESRD, severe depression, etc.), (3) Severe blindness, hearing impairment, or communication disability, (4) Branched-chain organic aciduria (e.g., maple syrup urine disease), (5) Individuals who do not consume fish or are allergic to fish products 2. Study design: A two-arm single-blind randomized controlled clinical trial will be performed for 24 weeks and the subjects will be divided in to 2 groups: (1) control group, (2) treatment group. S The treatment group were asked to consume 60mL/packet of perch essence, twice daily for 24 weeks, whereas the control group were provided with the same appearance, flavor, and color of fish stock. Participants were asked to maintain their dietary habit, lifestyle, and used of medication.\n\n3\\. Outcome assessment:\n\n1. Anthropometry data: height, weight, body mass index\n2. Blood biochemistry:\n\n A. Nutritional status: albumin, total protein, Vitamin B12, folate, magnesium B. Glycemic profiles: fasting blood glucose C. Lipid profiles: total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), triglycerides (TG).\n\n D. Complete blood counts: white blood cells (WBC), red blood cells (RBC), hemoglobin (HB), platelet count (PLT), hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC).\n\n E. Brain derived neurotrophic factor (BDNF), malondialdehyde (MDA)\n3. Urine test Urine color, appearance, specific gravity, pH, glucose, creatinine\n4. Cognitive function: Montreal cognitive assessment (MoCA), Cognitive abilities screening instruments (CASI)\n5. Nutrition status Mini-nutritional assessments (MNA), 3-day dietary recall The purpose of the study investigated the intervention of perch essence supplement on cognitive function and its correlation with nutritional status in MCI patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged ≥ 45\n* diagnosed with mild cognitive impairment by clinical dementia rating (CDR) with a scoring of 0.5\n* have the ability to communicate, reading and writing\n\nExclusion Criteria:\n\n* diagnosed with dementia\n* diagnosed with terminal diseases or severe psychological symptoms (lifespan ≤ 2 years, cancer, severe stroke, heart disease, liver cirrhosis, ESRD, severe depression, etc.)\n* Severe blindness, hearing impairment, or communication disability\n* Branched-chain organic aciduria (e.g., maple syrup urine disease)\n* Individuals who do not consume fish or are allergic to fish products'}, 'identificationModule': {'nctId': 'NCT07239635', 'briefTitle': 'Effect of Perch Essence on Cognitive Function Status in Subjects With Mild Cognitive Impairment', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University'}, 'officialTitle': 'Effect of Perch Essence on Cognitive Function Status in Subjects With Mild Cognitive Impairment', 'orgStudyIdInfo': {'id': 'N202401063'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Control group were asked to maintain their dietary habit, lifestyle, and used of medication, and were provided 60 mL/packet, twice daily for 24 weeks of fish stock with the same appearance, flavor, and color similar to perch essence as placebo.', 'interventionNames': ['Dietary Supplement: Fish stock']}, {'type': 'EXPERIMENTAL', 'label': 'Perch essence', 'description': 'Treatment group were asked to maintain their dietary habit, lifestyle, and used of medication, and were provided 60 mL/packet, twice daily for 24 weeks of perch essence.', 'interventionNames': ['Dietary Supplement: Perch essence']}], 'interventions': [{'name': 'Perch essence', 'type': 'DIETARY_SUPPLEMENT', 'description': '60mL/packet of perch essence, twice daily for 24 weeks', 'armGroupLabels': ['Perch essence']}, {'name': 'Fish stock', 'type': 'DIETARY_SUPPLEMENT', 'description': '60mL/packet of fish stock, twice daily for 24 weeks, with the same appearance, flavor, and color compared to perch essence', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110', 'city': 'Taipei', 'state': 'Xinyi', 'country': 'Taiwan', 'facility': 'School of Nutrition and Health Sciences', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}