Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-29 @ 2:32 AM
Study NCT ID:
NCT07161557
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-12
First Post:
2025-08-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Metabolic Health in People Aged 18 to 60 by Nutrilite Metabolic Health Index
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008659', 'term': 'Metabolic Diseases'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-05-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-07', 'studyFirstSubmitDate': '2025-08-28', 'studyFirstSubmitQcDate': '2025-09-04', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-04-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nutrilite Metabolic Health Index', 'timeFrame': 'day 1', 'description': 'Nutrilite Metabolic Health Index incorporates seven core biochemical parameters (see details in Secondary Outcome Measures): body mass index (BMI), waist circumference, fasting blood glucose (FBG) level, blood lipid profile (total cholesterol (TC), total triglycerides(TG), Low-Density Lipoprotein Cholesterol (LDL), High-Density Lipoprotein Cholesterol (HDL), blood pressure (Systolic Blood Pressure(SBP), and Diastolic Blood Pressure (BDP)), uric acid level, and history of fatty liver disease; along with four lifestyle and hereditary factors: smoking, alcohol consumption, age, and family history of metabolic diseases.\n\nAfter weighted calculation, the index score ranges from 0 to 100, divided into four grades:\n\nExcellent: 85-100 Moderate: 60-84 Poor: 40-59 Severe: 0-39'}], 'secondaryOutcomes': [{'measure': 'SBP', 'timeFrame': 'day 1', 'description': 'SBP(Systolic Blood Pressure), ideally \\<120 mmHg or still normal if less than 130mmHg'}, {'measure': 'DBP', 'timeFrame': 'day 1', 'description': 'BDP(Diastolic Blood Pressure), ideally \\<80 mmHg, or still normal if less than 89 mmHg'}, {'measure': 'Blood test - LDL-C', 'timeFrame': 'day 1', 'description': 'LDL-C(Low-Density Lipoprotein Cholesterol) concentration level in the blood sample test: normal range 0-3.1mmol/L, higher than 3.1 mmol/L is abnormal;'}, {'measure': 'Blood test - HDL-C', 'timeFrame': 'day 1', 'description': 'HDL-C(High-Density Lipoprotein Cholesterol) concentration level in the blood sample test: normal range 1.04\\~1.55 mmol/L, lower than 1.04 or higher than 1.55 mmol/L is abnormal;'}, {'measure': 'Blood test - TG', 'timeFrame': 'day 1', 'description': 'TG (Triglyceride) concentration level in the blood sample test : normal range 0\\~1.7 mmol/L, higher than 1.7mmol/L is abnormal'}, {'measure': 'Blood test - TC', 'timeFrame': 'day 1', 'description': 'TC (Total Cholesterol) concentration level in the blood sample test: normal range 3-5.2 mmol/L; higher than 5.2 mmol/L is abnormal.'}, {'measure': 'Blood test - FBG', 'timeFrame': 'day 1', 'description': 'FBG(Fasting Blood Glucose) concentration level in the blood sample test: normal range 4.-5.5mmol/L, higher than 5.5 mmol/L is abnormal.'}, {'measure': 'BMI', 'timeFrame': 'day 1', 'description': 'BMI (Body Mass Index), BMI is calculated by weight/height\\^2, where weight measured with unit kg, and height with unit meter, and weight and height will be combined to report BMI in kg/m\\^2.'}, {'measure': 'Waist Circumference', 'timeFrame': 'day 1', 'description': 'waist circumference measured in cm (centimeter)'}, {'measure': 'Uric Acid Level', 'timeFrame': 'day 1', 'description': 'uric acid level in μmol/L, the normal range for adult male：149～416μmol/L, adult female：89～357μmol/L'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diet2Me', 'Nutrilite Metabolic Health Index', 'Metabolic health omics model', 'Metabolomics testing'], 'conditions': ['Metabolic Abnormality', 'Metabolic Disorders']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to evaluate Metabolic Health by fit analysis between calculated Nutrilite Metabolic Health Index and the result of Metabolomics analysis from blood plasma samples in healthy adult participants aged between 18 and 60 years. The main question it aims to answer:\n\n\\- Does the Nutrilite Metabolic Health Index fit well with the result of Metabolomics analysis from blood plasma samples?\n\n200 eligible participants will be enrolled in a single center, one site visit will be made to finish a health questionnaire, a lifestyle questionnaire, a routine physical checkup. Blood samples will be collected for routine blood test (blood sugar, total triglycerides, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, uric acid), and for Metabolomics testing.\n\nResearchers will calculate the Nutrilite Metabolic Health Index based on participant data, and do the fit analysis against the result from Metabolomics analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male and female participants, aged 18 to 60, regardless of gender;', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female volunteers, aged 18 to 60, regardless of gender;\n* Not participating in other interventional clinical studies;\n* Have a good understanding of the nature, purpose, benefits obtained, and possible risks and side effects of the study;\n* Willing to comply with all trial requirements and procedures;\n* Sign the informed consent form.\n\nExclusion Criteria:\n\n* In the treatment of gastrointestinal symptoms;\n* Those who are lactose intolerant, allergic to fish and their products;\n* Current suffering from other organic diseases affecting bowel function, such as history of gastrointestinal resection, colon or rectal cancer, inflammatory bowel disease, diabetes, hyperthyroidism or hypothyroidism, Hirschsprung's disease, scleroderma, anorexia nervosa, etc.;\n* Diet control, exercise enhancement, or taking medications that control weight or affect appetite in the past 3 months;\n* Volunteers have any of the following medical history or have been clinically diagnosed with the following diseases that may affect the evaluation of the test results: obvious gastrointestinal disorders, liver, kidney, endocrine, blood, respiratory and cardiovascular diseases;\n* Current or past abuse of alcohol or other illicit drugs, supplements, or OTC prescriptions 3 / 11 Research content Collection of biological samples or information data Evaluation indicators Drugs may cause intestinal dysfunction or affect the evaluation of trial effects;\n* Frequent use of drugs that may affect gastrointestinal function or immune system according to the investigator's judgment."}, 'identificationModule': {'nctId': 'NCT07161557', 'briefTitle': 'Evaluating Metabolic Health in People Aged 18 to 60 by Nutrilite Metabolic Health Index', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amway (China) R&D Center'}, 'officialTitle': 'An Open Observational Study to Evaluate Metabolic Health in People Aged 18 to 60 by Nutrilite Metabolic Health Index', 'orgStudyIdInfo': {'id': '24-RD-10-AY-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All participants', 'description': 'All participants enrolled will be asked to fill out the questionnaires, have physical checkup, and take blood samples, no interventions involved.', 'interventionNames': ['Other: No Intervention: Observational Cohort']}], 'interventions': [{'name': 'No Intervention: Observational Cohort', 'type': 'OTHER', 'description': 'No intervention involved, participants will fill out some questionnaires and blood samples will drawn for test and analysis.', 'armGroupLabels': ['All participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '201900', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai MCC Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Charlie Zhang, MD', 'role': 'CONTACT', 'email': 'charlie.zhang@raisonbiotech.com', 'phone': '+8613901981272'}], 'overallOfficials': [{'name': 'Zheng Qu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai MCC Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amway (China) R&D Center', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}