Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2025-12-29 @ 12:14 PM
Study NCT ID:
NCT06305650
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2024-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotic Influence on Obesity-Related Lipidemia
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Double（Participant,Investigator）'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-11', 'studyFirstSubmitDate': '2024-03-05', 'studyFirstSubmitQcDate': '2024-03-05', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect on body mass index (BMI) values.', 'timeFrame': '12 weeks', 'description': "After the probiotic intervention, the change in body mass index (BMI) from baseline in obese/overweight individuals will be calculated. BMI is measured by dividing a person's weight in kilograms by the square of their height in meters (kg/m\\^2)."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Probiotic', 'Obesity'], 'conditions': ['Overweight or Obesity']}, 'descriptionModule': {'briefSummary': "This study aims to investigate the effects of Bifidobacterium breve BBr60 on key health indicators in overweight and obese adults. Specifically, it will assess the probiotic's impact on body composition metrics such as BMI, body fat percentage, WHR, and BMR. The inclusion criteria for participants are a BMI of ≥28 kg/m\\^2, targeting individuals who stand to benefit significantly from metabolic and body composition improvements."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Body mass index (BMI) ≥ 28 kg/m2;\n2. Voluntarily, in writing, and signing the informed consent form, agreeing to participate in this study;\n3. Those who agree to abide by the protocol and study restrictions and are able to comply with a low-carbohydrate, energy-restricted diet plan.\n4. Subjects (including male subjects) have no plans to have children from 14 days before screening to 6 months after the end of the trial and voluntarily take effective contraceptive measures;\n\nExclusion Criteria:\n\n1. Taking items with similar functions to those tested in a short period of time will affect the judgment of the results;\n2. Patients with severe allergies and immune deficiency;\n3. Women who are pregnant, breastfeeding or planning to become pregnant;\n4. Severe diseases of cardiovascular, lungs, liver, kidneys and other important organs, diabetes, thyroid disease, severe metabolic diseases, malignant tumors, and severe immune system diseases;\n5. People who have used antibiotics in the past two weeks;\n6. Those who failed to consume the test samples as required or failed to follow up on time, resulting in uncertainty in determining the efficacy;\n7. Have used laxatives or fiber supplements in the past 6 weeks;\n8. Subjects judged by other researchers to be unfit to participate. Those who meet any of the above conditions will not be selected.'}, 'identificationModule': {'nctId': 'NCT06305650', 'briefTitle': 'Probiotic Influence on Obesity-Related Lipidemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wecare Probiotics Co., Ltd.'}, 'officialTitle': 'The Efficacy and Safety of a Probiotic in Reducing Body Fat and Blood Lipids Among Overweight and Obese Individuals', 'orgStudyIdInfo': {'id': 'WK2024001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic group', 'description': 'one bag/day BBr60, before meals', 'interventionNames': ['Dietary Supplement: Probiotic']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Maltodextrin, one bag/day, before meals', 'interventionNames': ['Dietary Supplement: Probiotic']}], 'interventions': [{'name': 'Probiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': "Through oral probiotic intervention for 12 weeks, participants' BMI, body fat percentage, and waist-to-hip ratio will be measured at weeks 0, 6, and 12, and fecal samples will be collected at weeks 0 and 12 for gut microbiota analysis.", 'armGroupLabels': ['Placebo group', 'Probiotic group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '471000', 'city': 'Luoyang', 'state': 'Henan', 'country': 'China', 'facility': 'Henan University of Science and Technology', 'geoPoint': {'lat': 34.67345, 'lon': 112.43684}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wecare Probiotics Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}