Intermittent Fasting for Inflammation and Depression in Spinal Cord Injury

Summary

Depression and chronic inflammation are common problems for people with spinal cord injury (SCI). Inflammation has been shown to influence depression which may make it an important treatment target. Previous studies have shown that changes in diet and exercise can affect this pathway and improve symptoms of depression in SCI patients. However, following these interventions long-term can be difficult.

Intermittent fasting is a way of eating that involves fasting for a certain period of time and then eating normally. It has been shown to reduce inflammation and improve mood in able-bodied people, but its unknown if it can help people with depression and chronic inflammation, such as those with SCI. As intermittent fasting is a simple, easier to follow strategy than a diet it may be a more feasible long-term strategy. In addition, certain behavioural techniques such education, encouragement, and self monitoring may further help. This study aims to find out if intermittent fasting + support can be a helpful and simpler treatment for depression in SCI patients.

In this study, 32 individuals with SCI who have depression will be invited to be randomly assigned to either try intermittent fasting + support or intermittent fasting alone. Both groups will fast for 16 hours per day for 8-weeks but only the supported group will receive behaviour techniques. Measurements will be taken prior to starting the interventions and after completing the interventions to assess for any changes in depression. Adherence, safety and inflammation will also be assessed.

By the end of the study, the investigators hope that intermittent fasting can help safely reduce symptoms of depression and inflammation in people with SCI. The investigators also hope to find that additional behavior support further helps people adhere. This may provide a simple, easy to follow, and cost-free treatment for depression and inflammation in people with SCI.

Conditions

• Spinal Cord Injury
• Depression - Major Depressive Disorder

Interventions

BEHAVIORAL

Intermittent fasting

Participants will follow a 16:8 protocol whereby they will be asked to fast for 16 hours per day and allowed to eat ad-libitum for the remaining 8 hours. While (for feasibility purposes) it will be a requirement that the fasting period include time spent asleep, participants will be allowed some degree of flexibility in the start and end time of their fasting period. This will be performed in order to accommodate participant preferences (sleeping/eating/medication schedules) as best as possible and provide a sense of autonomy. During the non-fasting hours, participants will be permitted to eat ad libitum.

BEHAVIORAL

Behavioral Support Strategies

Evidence-based self regulatory health behaviour support techniques including education, ongoing tailored feedback and encouragement, self monitoring tools, and goal setting will be used to help participants adhere to the fasting protocol. These techniques will be implemented via weekly phone calls to allow for coaching (e.g. barrier identification, strategies/action planning to overcome barriers, goal setting) as well as a smartphone app. The smartphone application will provide information pertaining to intermittent fasting including lay summaries of clinical trials as well as infographics related to healthy eating for the ad-libitum eating periods. Tips for healthy eating on a budget and adhering to an intermittent fasting protocol will also be provided. The smartphone app will also feature intermittent fasting start and stop time reminders, hydration reminders, and the ability to set one's individualized fasting schedule and record actual daily fasting windows.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  lead OTHER

Principal Investigators

• David J Allison, PhD. · Lawson Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-01

Primary Completion

2026-12-30

Completion

2027-04-30

Countries

• Canada

Study Locations