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

Sponsor

Northern Arizona University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04030858

Collaborator

(none)

125

Enrollment

Arms

22.9

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Mental Health Issue Addiction	Behavioral: Plant-based diet + nutrition education	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

125 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 3, 2019

Anticipated Primary Completion Date :

Aug 1, 2021

Anticipated Study Completion Date :

Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment group The treatment group will eat a nutrient-dense plant-based diet and attend weekly nutrition education sessions.	Behavioral: 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.
No Intervention: Control group

Arm

Intervention/Treatment

Experimental: Treatment group

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

Behavioral: 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.

No Intervention: Control group

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age 18 or older
Entering inpatient treatment at Infinite Recovery Addiction Treatment Facility

Exclusion Criteria:

Pregnant
Psychiatrically unstable.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Northern Arizona University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jay Sutliffe, Associate Professor, Northern Arizona University

ClinicalTrials.gov Identifier:

NCT04030858

Other Study ID Numbers:

1410688

First Posted:

Jul 24, 2019

Last Update Posted:

Jul 24, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Behavior, Addictive

Study Results

No Results Posted as of Jul 24, 2019