Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-02-26 @ 6:53 AM
Study NCT ID:
NCT04030858
Status:
UNKNOWN
Last Update Posted:
2019-07-24
First Post:
2019-06-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The INFINITE Study: A Prospective Investigation of a Nutrient-dense Diet in Early Addiction Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016739', 'term': 'Behavior, Addictive'}], 'ancestors': [{'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000095500', 'term': 'Diet, Plant-Based'}, {'id': 'D015596', 'term': 'Nutrition Assessment'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a randomized controlled trial with an intervention and control group comparison.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-09-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-22', 'studyFirstSubmitDate': '2019-06-05', 'studyFirstSubmitQcDate': '2019-07-22', 'lastUpdatePostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resilience', 'timeFrame': 'Change from baseline to week 3', 'description': 'Measured by the Connor-Davidson Resilience Scale (CD-RISC); scale scores range 0-100, with higher values representing better outcomes.'}, {'measure': 'Resilience', 'timeFrame': 'Change from baseline to week 10', 'description': 'Measured by the Connor-Davidson Resilience Scale (CD-RISC); scale scores range 0-100, with higher values representing better outcomes.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mental Health Issue', 'Addiction']}, 'descriptionModule': {'briefSummary': 'The trial will be placed within an ongoing addiction recovery program at Infinite Recovery in Austin, TX. Members with any addiction enrolling in an inpatient treatment program at Infinite Recovery will be recruited into this 1-year study to evaluate the effectiveness of a plant-based diet to aid drug and/or alcohol addiction recovery. Volunteers willing to participate in the trial will be randomly assigned to a treatment or control group. Those in the treatment group will follow the standard protocol offered by Infinite Recovery, with the exception that they will be provided with only plant-based meals. Both groups will also receive nutrition education to support their dietary plan. Several health and wellbeing endpoints will be assessed as part of the standard care at Infinite Recovery, combined with a few additional measurements described within this study protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older\n* Entering inpatient treatment at Infinite Recovery Addiction Treatment Facility\n\nExclusion Criteria:\n\n* Pregnant\n* Psychiatrically unstable.'}, 'identificationModule': {'nctId': 'NCT04030858', 'briefTitle': 'The INFINITE Study: A Prospective Investigation of a Nutrient-dense Diet in Early Addiction Recovery', 'organization': {'class': 'OTHER', 'fullName': 'Northern Arizona University'}, 'officialTitle': 'The INFINITE Study: A Prospective Investigation of a Nutrient-dense Diet in Early Addiction Recovery', 'orgStudyIdInfo': {'id': '1410688'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'The treatment group will eat a nutrient-dense plant-based diet and attend weekly nutrition education sessions.', 'interventionNames': ['Behavioral: Plant-based diet + nutrition education']}, {'type': 'NO_INTERVENTION', 'label': 'Control group'}], 'interventions': [{'name': 'Plant-based diet + nutrition education', 'type': 'BEHAVIORAL', 'description': 'The intervention group will adopt a nutrient-dense dietary pattern and receive nutrition education sessions specific to that lifestyle. The diet protocol is comprised of minimally-processed plant foods such as fruits, vegetables, legumes, beans, nuts and seeds. No refined sugars, added salt, or oil will be included. Dietary fat intake limited to 20% of total calories or less per day. Animal products will be eliminated. This dietary pattern is expected to improve resilience, mood, inflammation, microbiome, spirituality, and overall general health (as measured by weight, cholesterol, blood pressure). The treatment group will also receive weekly nutrition education sessions to support the diet.', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Tara Kemp, BA', 'role': 'CONTACT', 'email': 'tk479@nau.edu', 'phone': '7249726224'}, {'name': 'Jay Sutliffe, PhD', 'role': 'CONTACT', 'email': 'jay.sutliffe@nau.edu', 'phone': '928-523-7450'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northern Arizona University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jay Sutliffe', 'investigatorAffiliation': 'Northern Arizona University'}}}}