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

Mental Health Issue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04030858
• Other study ID #: 1410688
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 3, 2019
• Est. completion date: August 2021

Study information

• Verified date: July 2019
• Source: Northern Arizona University
• Contact: Tara Kemp, BA
• Phone: 7249726224
• Email: tk479[@]nau.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 125
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or older

• Entering inpatient treatment at Infinite Recovery Addiction Treatment Facility

Exclusion Criteria:

• Pregnant

• Psychiatrically unstable.

Related Conditions & MeSH terms

• Addiction
• Behavior, Addictive
• Mental Health Issue

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Northern Arizona University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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