32 Participants Needed

Intermittent Fasting for Spinal Cord Injury

DJ
Overseen ByDavid 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
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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.12345

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.12456

Who Is on the Research Team?

DJ

David J Allison, PhD.

Principal Investigator

Lawson Research Institute

Are You a Good Fit for This Trial?

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
My depression medication dose has not changed recently.

Exclusion Criteria

I am currently taking blood thinner medications.
People with diabetes
I have thoughts of harming myself.
See 6 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Intermittent Fasting + Behavioral Support StrategiesExperimental Treatment2 Interventions
Group II: Intermittent Fasting OnlyActive Control1 Intervention

Find a Clinic Near You

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+

Citations

Safety of Every-Other-Day Fasting in the Treatment of Spinal Cord Injury: A Randomized Controlled Trial. [2021]
Intermittent fasting improves functional recovery after rat thoracic contusion spinal cord injury. [2021]
Prophylactic dietary restriction may promote functional recovery and increase lifespan after spinal cord injury. [2010]
Gut microbiota and transcriptome dynamics in every-other-day fasting are associated with neuroprotection in rats with spinal cord injury. [2023]
Early versus late enteral feeding in patients with acute cervical spinal cord injury: a pilot study. [2022]
Intermittent fasting in mice does not improve hindlimb motor performance after spinal cord injury. [2011]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security