The INFINITE Study: A Prospective Investigation of a Nutrient-dense Diet in Early Addiction Recovery
Primary Purpose
Mental Health Issue, Addiction
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Plant-based diet + nutrition education
Sponsored by
About this trial
This is an interventional treatment trial for Mental Health Issue
Eligibility Criteria
Inclusion Criteria:
- Age 18 or older
- Entering inpatient treatment at Infinite Recovery Addiction Treatment Facility
Exclusion Criteria:
- Pregnant
- Psychiatrically unstable.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment group
Control group
Arm Description
The treatment group will eat a nutrient-dense plant-based diet and attend weekly nutrition education sessions.
Outcomes
Primary Outcome Measures
Resilience
Measured by the Connor-Davidson Resilience Scale (CD-RISC); scale scores range 0-100, with higher values representing better outcomes.
Resilience
Measured by the Connor-Davidson Resilience Scale (CD-RISC); scale scores range 0-100, with higher values representing better outcomes.
Secondary Outcome Measures
Full Information
NCT ID
NCT04030858
First Posted
June 5, 2019
Last Updated
July 22, 2019
Sponsor
Northern Arizona University
1. Study Identification
Unique Protocol Identification Number
NCT04030858
Brief Title
The INFINITE Study: A Prospective Investigation of a Nutrient-dense Diet in Early Addiction Recovery
Official Title
The INFINITE Study: A Prospective Investigation of a Nutrient-dense Diet in Early Addiction Recovery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 3, 2019 (Anticipated)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northern Arizona University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Issue, Addiction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized controlled trial with an intervention and control group comparison.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
The treatment group will eat a nutrient-dense plant-based diet and attend weekly nutrition education sessions.
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Plant-based diet + nutrition education
Intervention 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.
Primary Outcome Measure Information:
Title
Resilience
Description
Measured by the Connor-Davidson Resilience Scale (CD-RISC); scale scores range 0-100, with higher values representing better outcomes.
Time Frame
Change from baseline to week 3
Title
Resilience
Description
Measured by the Connor-Davidson Resilience Scale (CD-RISC); scale scores range 0-100, with higher values representing better outcomes.
Time Frame
Change from baseline to week 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18 or older
Entering inpatient treatment at Infinite Recovery Addiction Treatment Facility
Exclusion Criteria:
Pregnant
Psychiatrically unstable.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tara Kemp, BA
Phone
7249726224
Email
tk479@nau.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jay Sutliffe, PhD
Phone
928-523-7450
Email
jay.sutliffe@nau.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The INFINITE Study: A Prospective Investigation of a Nutrient-dense Diet in Early Addiction Recovery
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