The INFINITE Study: A Prospective Investigation of a Nutrient-dense Diet in Early Addiction Recovery

Study Overview
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Brief Summary
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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.

Official Title
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The INFINITE Study: A Prospective Investigation of a Nutrient-dense Diet in Early Addiction Recovery

Conditions
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Addiction, Mental Health Issue

Intervention / Treatment
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* Behavioral: Plant-based diet + nutrition education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older Entering inpatient treatment at Infinite Recovery Addiction Treatment Facility Exclusion Criteria: Pregnant Psychiatrically unstable.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a randomized controlled trial with an intervention and control group comparison.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>The treatment group will eat a nutrient-dense plant-based diet and attend weekly nutrition education sessions. | Behavioral: Plant-based diet + nutrition education<br>* 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.<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resilience | Measured by the Connor-Davidson Resilience Scale (CD-RISC); scale scores range 0-100, with higher values representing better outcomes. | Change from baseline to week 3 | 
| Resilience | Measured by the Connor-Davidson Resilience Scale (CD-RISC); scale scores range 0-100, with higher values representing better outcomes. | Change from baseline to week 10 |