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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether intermittent fasting can reduce depression and inflammation in people with spinal cord injuries (SCI). Participants will fast for 16 hours a day over eight weeks, with some receiving additional support, such as education and encouragement, to determine if it enhances the benefits. The trial aims to find a simple, cost-effective way to manage depression and inflammation in SCI patients. Individuals who have had a spinal cord injury for at least a year and experience mild to moderate depression might be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could lead to new, accessible treatments for SCI-related depression and inflammation.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that intermittent fasting is generally safe for most people, including those with specific health conditions like spinal cord injury (SCI). One study on fasting every other day found it was well-tolerated by people with SCI, with no serious side effects reported. Other studies in animals also suggest benefits, such as better recovery after SCI, without major safety concerns.

While the long-term effects of intermittent fasting in people with SCI remain unclear, existing studies in similar situations indicate it is safe. This trial will carefully monitor participants to ensure their health and safety. Prospective participants can be confident that the researchers prioritize their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using intermittent fasting for spinal cord injury because it offers a fresh approach compared to traditional treatments like physical therapy, medications, or surgery. Intermittent fasting is unique as it involves a dietary pattern that restricts eating to an 8-hour window each day, potentially providing metabolic benefits that aid in recovery. Additionally, one arm of the study combines fasting with behavioral support strategies, including coaching and self-monitoring through a smartphone app, which could enhance adherence and effectiveness. This approach is different from the typical focus on physical or pharmaceutical interventions and aims to harness the body's natural processes for potential healing and improvement.

What evidence suggests that intermittent fasting might be an effective treatment for depression in people with spinal cord injury?

Research has shown that intermittent fasting can lower inflammation and boost mood in people without spinal cord injuries. Animal studies have suggested that intermittent fasting might aid recovery after spinal cord injuries. However, its effects on depression and inflammation in people with spinal cord injuries remain unclear. This trial will compare two approaches: one group will follow an intermittent fasting protocol combined with behavioral support strategies, while another group will follow the intermittent fasting protocol without additional support. Intermittent fasting is a simple eating pattern that might be easier to maintain than strict diets, making it a potentially good long-term choice. Early findings suggest that combining fasting with support, such as encouragement and self-monitoring, might help people adhere to the routine better. More research is needed to confirm these benefits for people with spinal cord injuries. ^{1 2 3 6 7}

Who Is on the Research Team?

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.

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?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3119327/

Intermittent Fasting Improves Functional Recovery after Rat ... We now report that alternating periods of fasting (but not pair-fed) also promotes improved hindlimb locomotion after thoracic spinal cord contusion.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06807528

Intermittent Fasting for Inflammation and Depression in ... This may provide a simple, easy to follow, and cost-free treatment for depression and inflammation in people with SCI. Detailed Description. Background: ...

3. frontiersin.org frontiersin.org/journals/physiology/articles/10.3389/fphys.2020.00865/full

Intermittent Fasting After Spinal Cord Injury Does Not ... Dietary restriction in the form of every other day fasting (EODF) has been shown to have beneficial effects on the recovery of motor function after SCI in rats.

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0244244

Nerve injury and repair in a ketogenic milieu - Research journals Intermittent fasting improves functional recovery after rat thoracic contusion spinal cord injury. J Neurotrauma. 2011;28(3):479–492. doi ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2161831325000845

Unraveling Spinal Cord Injury Nutrition: Effects of Diet on ... Intermittent fasting in mice does not improve hindlimb motor performance after spinal cord injury. J. Neurotrauma, 28 (6) (2011), pp. 1051-1061, 10.1089/neu ...

6. europepmc.org europepmc.org/article/ppr/ppr461685

The Effects of Intermittent Fasting from Dawn to Sunset for ... Animal studies have shown that intermittent fasting (IF) has a neuroprotective effect on SCI, but it has not been used in clinical treatment of SCI.

7. researchgate.net researchgate.net/publication/349646233_Safety_of_Every-Other-Day_Fasting_in_the_Treatment_of_Spinal_Cord_Injury_A_Randomized_Controlled_Trial

(PDF) Safety of Every-Other-Day Fasting in the Treatment ... A randomized controlled study was conducted to investigate the safety of every-other-day fasting in patients with spinal cord injury.