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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
Northern Arizona University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Health Issue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    June 5, 2019
    Last Updated
    July 22, 2019
    Sponsor
    Northern Arizona University
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    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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