Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT05443269
Status:
UNKNOWN
Last Update Posted:
2022-07-05
First Post:
2022-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Jump Start Nutrition Program on Weight Loss and Associated Measures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-04-05', 'releaseDate': '2023-10-10'}], 'estimatedResultsFirstSubmitDate': '2023-10-10'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-29', 'studyFirstSubmitDate': '2022-06-29', 'studyFirstSubmitQcDate': '2022-06-29', 'lastUpdatePostDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body Composition', 'timeFrame': 'Day 8', 'description': 'Changes in body composition as measured by dual-energy X-ray absorptiometry from baseline'}, {'measure': 'Lipids Panel', 'timeFrame': 'Day 8', 'description': 'Changes in lipids panel from baseline'}, {'measure': 'Glucose', 'timeFrame': 'Day 8', 'description': 'Changes in glucose from baseline'}, {'measure': 'Insulin', 'timeFrame': 'Day 8', 'description': 'Changes in insulin from baseline'}, {'measure': 'Body Weight', 'timeFrame': 'Day 8', 'description': 'Changes in body weight from baseline'}, {'measure': 'Body Mass Index', 'timeFrame': 'Day 8', 'description': 'Changes in body mass index from baseline'}, {'measure': 'Resting Blood pressure', 'timeFrame': 'Day 8', 'description': 'Changes in resting blood pressure from baseline'}, {'measure': 'Resting Heart Rate', 'timeFrame': 'Day 8', 'description': 'Changes in resting heart rate from baseline'}, {'measure': "Subjects' perceived wellness", 'timeFrame': 'Day 8', 'description': 'Changes in subjects perceived wellness from baseline using a visual analog scale from 0 to 10 with 0 being very low and 10 being extremely high'}, {'measure': 'Hip Circumference', 'timeFrame': 'Day 8', 'description': 'Changes in hip circumference from baseline'}, {'measure': 'Waist Circumference', 'timeFrame': 'Day 8', 'description': 'Changes in waist circumference from baseline'}, {'measure': 'Physical Appearance', 'timeFrame': 'Day 8', 'description': 'Changes in physical appearance of trunk region from bottom of neck to knee region'}], 'secondaryOutcomes': [{'measure': 'Diet', 'timeFrame': 'Day 8', 'description': 'Changes in diet from before intervention determined using food logs'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Jump Start', 'USANA'], 'conditions': ['Weight Loss']}, 'descriptionModule': {'briefSummary': 'The purpose of the proposed study is to evaluate the impact of the Jump Start program to facilitate weight loss in a sample of overweight and obese men and women. The study will not only evaluate weight loss and changes in body-shape but will also assess the type of weight lost (fat vs. lean mass) and other health measures affected by obesity including lipids, glucose, insulin, resting heart rate and blood pressure, and perceived wellness. This study will contribute to the general weight loss literature by providing evidence for or against the use of a meal replacement centered one-week weight loss program to yield weight loss and other health-specific benefits. The hypothesis is that the Jump Start program will result in an average 3-5 pound weight loss, as well as improvements in bloodborne markers of health, from day 1 to day 8.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI of 28-39.9 kg/m2\n* can fast \\>10 hours\n* maintain existing exercise regiment during study\n\nExclusion Criteria:\n\n* Weight greater than 500 lbs\n* Type I or II diabetic\n* liver disease\n* tobacco user\n* adversity to fiber or protein supplement\n* taking weight loss dietary supplements or adhering to any weight loss plan in the month prior to and during participation in the study\n* taking a multi-vitamin or pro-biotic, or if they were not recommended by a doctor, willing to stop for 4 weeks prior to the study.\n* consumption of alcohol or caffeine within 24 hours of each testing visit\n* strenuous exercise during the 24 hours period before each testing visit\n* self-reported active infection or illness of any kind\n* pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT05443269', 'briefTitle': 'Impact of Jump Start Nutrition Program on Weight Loss and Associated Measures', 'organization': {'class': 'OTHER', 'fullName': 'University of Memphis'}, 'officialTitle': 'Impact of Jump Start Nutrition Program on Weight Loss and Associated Measures of Health in Overweight and Obese Men and Women', 'orgStudyIdInfo': {'id': 'PRO-FY2022-183'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Jump Start Program', 'description': 'The intervention consists of following the Jump Start plan for 7 days', 'interventionNames': ['Dietary Supplement: Jump Start Nutritional Program']}], 'interventions': [{'name': 'Jump Start Nutritional Program', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Nutri-meal Active meal replacement shake and Metabolism pill at breakfast, lunch, and dinner, morning and evening Health Pak (multivitamin), 1 probiotic stick, and 300 calories fruits and vegetables daily', 'armGroupLabels': ['Jump Start Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38156', 'city': 'Memphis', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jacquelyn Pence, PhD', 'role': 'CONTACT', 'email': 'jpence1@memphis.edu', 'phone': '901-678-1547'}], 'facility': 'Center for Nutraceutical and Dietary Supplement Research', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'centralContacts': [{'name': 'Jacquelyn Pence, PhD', 'role': 'CONTACT', 'email': 'jpence1@memphis.edu', 'phone': '901-678-1547'}], 'overallOfficials': [{'name': 'Jacquelyn Pence, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Assistant Professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Memphis', 'class': 'OTHER'}, 'collaborators': [{'name': 'USANA Health Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-10-10', 'type': 'RELEASE'}, {'date': '2024-04-05', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University of Memphis'}}}}