Intermittent Fasting for Spinal Cord Injury

Overseen By David J Allison, PhD.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Must be taking: Depression medications

Must not be taking: Anti-inflammatories, Anticoagulants

Disqualifiers: Diabetes, Pregnancy, Suicidal ideation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

32 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that participants have a stable dose of depression medications, so you won't need to stop those. However, if you are using anti-inflammatory or anticoagulant medications, you cannot participate in the trial.

What data supports the effectiveness of the treatment Intermittent Fasting for Spinal Cord Injury?

Research in rats shows that intermittent fasting, specifically every-other-day fasting, can help improve movement and recovery after spinal cord injury. It also suggests that this type of fasting might protect nerve cells and reduce injury size, which could be beneficial for people with spinal cord injuries. ^{1 2 3 4 5}

Is intermittent fasting safe for people with spinal cord injury?

Every-other-day fasting is generally considered safe for individuals with spinal cord injury, as studies show it does not cause harmful changes in blood sugar, body weight, or other health markers. ^{1 2 3 4 6}

How does intermittent fasting differ from other treatments for spinal cord injury?

Intermittent fasting, specifically every-other-day fasting, is unique because it involves alternating periods of fasting and eating, which may promote functional recovery and reduce lesion size in spinal cord injury. Unlike other treatments, it focuses on dietary patterns rather than medication or surgery, and has shown potential benefits in animal studies by improving neuron survival and reducing secondary complications. ^{1 2 3 4 6}

Research Team

David J Allison, PhD.

Principal Investigator

Lawson Research Institute

Eligibility Criteria

This trial is for individuals with spinal cord injury (SCI) who are also experiencing depression. Participants should be interested in trying intermittent fasting as a potential treatment. The study excludes those who cannot safely fast or have conditions that might interfere with the intervention.

Inclusion Criteria

I have had a spinal cord injury for over a year.

Mild to moderate scores of depression based on the Structured Clinical Interview for DSM-5 (SCID) by clinical psychologist

I am 18 years old or older.

Exclusion Criteria

I am currently taking blood thinner medications.

People with diabetes

I have thoughts of harming myself.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo intermittent fasting for 16 hours per day for 8 weeks, with one group receiving additional behavioral support

8 weeks

Weekly phone calls for adherence and safety monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Behavioral Support Strategies
• Intermittent Fasting

Trial Overview The study tests whether intermittent fasting can reduce inflammation and alleviate depression in SCI patients. It compares two groups: one practicing fasting alone, and another combining fasting with behavioral support strategies like education and encouragement over an 8-week period.

Participant Groups

Group I: Intermittent Fasting + Behavioral Support Strategies Experimental Treatment 2 Interventions

The intermittent fasting + behavioral strategies arm 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. This arm will also receive behavioral strategies 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

Group II: Intermittent Fasting Only Active Control 1 Intervention

Participants allocated to the intermittent fasting only group will undergo the same 16:8 intermittent fasting protocol, however, they will not be provided with behavioral strategies via phone calls or the smart phone application. Weekly phone calls will be performed only for the purposes of assessing adherence, tracking adverse events, and ensuring participant safety.

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

686

Recruited

427,000+

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

Lead Sponsor

Trials

678

Recruited

421,000+

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

Lead Sponsor

Trials

668

Recruited

424,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Safety of Every-Other-Day Fasting in the Treatment of Spinal Cord Injury: A Randomized Controlled Trial. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Intermittent fasting improves functional recovery after rat thoracic contusion spinal cord injury. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Prophylactic dietary restriction may promote functional recovery and increase lifespan after spinal cord injury. [2010]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Gut microbiota and transcriptome dynamics in every-other-day fasting are associated with neuroprotection in rats with spinal cord injury. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Early versus late enteral feeding in patients with acute cervical spinal cord injury: a pilot study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Intermittent fasting in mice does not improve hindlimb motor performance after spinal cord injury. [2011]