Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT07103993
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-25
First Post:
2025-07-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Food Intake and Thermogenesis in High Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2025-07-29', 'studyFirstSubmitQcDate': '2025-07-29', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diet induced thermogenesis (DIT)', 'timeFrame': 'up to 3 weeks (collected during each of the intervention visits)', 'description': 'Diet-induced thermogenesis (DIT) will be measured using indirect calorimetry. A portable mask-based metabolic system, which will measure expired air to calculate dietary-induced thermogenesis defined as the energy expended above resting and the proportion of meal energy expended postprandially (postprandial kilocalorie (kcal) expended/total meal kcal) where a higher value means more energy is expended.'}, {'measure': 'Hunger Series Visual Analog Scale', 'timeFrame': 'up to 3 weeks (collected during each of the intervention visits)', 'description': 'Satiety will be measured using the Hunger Series Visual Analog Scale (HSVAS), which assesses subjective appetite. Each scale is defined at 0 as "not at all hungry" and 100 as "totally/a lot/very hungry". A sum score will be calculated.'}, {'measure': 'Post ad-libitum energy intake measured in grams', 'timeFrame': 'up to 3 weeks (collected during each of the intervention visits)', 'description': 'This value will be expressed as a ratio of energy consumed to energy requirements (energy intake/energy requirements x 100) and will be recorded in grams.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SCI - Spinal Cord Injury']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to determine the effects of food on cardiovascular and metabolic health in men with and without spinal cord injury (SCI).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Male subjects', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSCI and Controls\n\n* Men\n* Physically inactive (\\<150 minutes per week of moderate-vigorous activity intensity for the preceding 3 months)\n* Weight stable: body mass ±3 kilograms (kg) for past 3 months\n\nSCI Only\n\n* Chronic SCI (≥ 1-year post-injury)\n* Motor-complete SCI American Spinal Injury Association Impairment Scale (AIS) A and B\n* T6 injuries and above that can independently feed themselves\n\nExclusion Criteria:\n\nSCI and Controls\n\n* Uncompensated thyroid disease\n* Diabetes\n* Swallowing or gastrointestinal pathologies\n* Allergies or aversions to foods/ingredients\n* Prescribed prokinetic, antipsychotic, or anti-obesity agents\n\nSCI Only\n\n* Incomplete SCI AIS C or D\n* Ventilator-dependent'}, 'identificationModule': {'nctId': 'NCT07103993', 'briefTitle': 'Food Intake and Thermogenesis in High Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Food Intake and Thermogenesis in High Spinal Cord Injury', 'orgStudyIdInfo': {'id': '20250335'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low meal condition group', 'description': 'Subjects will be in this group for up to 3 weeks.', 'interventionNames': ['Other: Low meal condition', 'Other: Ad-libitum control condition']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate meal condition group', 'description': 'Subjects will be in this group for up to 3 weeks.', 'interventionNames': ['Other: Moderate meal condition', 'Other: Ad-libitum control condition']}, {'type': 'EXPERIMENTAL', 'label': 'High meal condition group', 'description': 'Subjects will be in this group for up to 3 weeks.', 'interventionNames': ['Other: High meal condition', 'Other: Ad-libitum control condition']}], 'interventions': [{'name': 'Low meal condition', 'type': 'OTHER', 'description': 'Participants will consume a standardized meal (500 grams) with a low nutrient modification one time at one visit. Participants will attend one visit per week for 3 weeks. Each is visit separated by one week and each visit will take approximately 6 hours', 'armGroupLabels': ['Low meal condition group']}, {'name': 'Moderate meal condition', 'type': 'OTHER', 'description': 'Participants will consume a standardized meal (500 grams) with a moderate nutrient modification one time at one visit. Participants will attend one visit per week for 3 weeks. Each is visit separated by one week and each visit will take approximately 6 hours.', 'armGroupLabels': ['Moderate meal condition group']}, {'name': 'High meal condition', 'type': 'OTHER', 'description': 'Participants will consume a standardized meal (500 grams) with a high nutrient modification one time at one visit. Participants will attend one visit per week for 3 weeks. Each is visit separated by one week and each visit will take approximately 6 hours.', 'armGroupLabels': ['High meal condition group']}, {'name': 'Ad-libitum control condition', 'type': 'OTHER', 'description': 'The ad-libitum meal consists of 600-700 g of a standardized control meal one time at all visits. Participants will attend one visit per week for 3 weeks. Each visit is separated by one week and each visit will take approximately 6 hours.', 'armGroupLabels': ['High meal condition group', 'Low meal condition group', 'Moderate meal condition group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'contacts': [{'name': 'Gary J Farkas, PhD', 'role': 'CONTACT', 'email': 'gjf50@med.miami.edu', 'phone': '305-243-4518'}, {'name': 'Guillermo Mederos', 'role': 'CONTACT', 'email': 'gxm1228@med.miami.edu', 'phone': '305-243-3543'}, {'name': 'Gary J Farkas, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Miami - Miami Project to Cure Paralysis', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'centralContacts': [{'name': 'Guillermo Mederos', 'role': 'CONTACT', 'email': 'gxm1228@med.miami.edu', 'phone': '(305) 243-4518'}, {'name': 'Gary J Farkas, PhD', 'role': 'CONTACT', 'email': 'gjf50@med.miami.edu', 'phone': '(305) 243-4518'}], 'overallOfficials': [{'name': 'Gary J Farkas, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Craig H. Neilsen Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Gary Farkas', 'investigatorAffiliation': 'University of Miami'}}}}