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

NCT ID: NCT04030858

Last Updated: 2019-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-03

Study Completion Date

2021-08-31

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.

Detailed Description

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Conditions

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Mental Health Issue Addiction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized controlled trial with an intervention and control group comparison.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment group

The treatment group will eat a nutrient-dense plant-based diet and attend weekly nutrition education sessions.

Group Type EXPERIMENTAL

Plant-based diet + nutrition education

Intervention Type BEHAVIORAL

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.

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Plant-based diet + nutrition education

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.

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northern Arizona University

OTHER

Sponsor Role lead

Responsible Party

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Jay Sutliffe

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Tara Kemp, BA

Role: CONTACT

7249726224

Jay Sutliffe, PhD

Role: CONTACT

928-523-7450

Other Identifiers

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1410688

Identifier Type: -

Identifier Source: org_study_id

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