Clinical trial NCT06807528: Intermittent Fasting for Inflammation and Depression in Spinal Cord Injury
Official title: Intermittent Fasting as an Anti-inflammatory Strategy for the Treatment of Depression in Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spinal Cord Injury
Depression - Major Depressive Disorder
Keywords: spinal cord injury
inflammation
depression
intermittent fasting
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible participants who consent to study participation will be randomized to one of two groups: intermittent fasting + behavioral support techniques or intermittent fasting only. Each group will undergo 8-weeks of the respective treatment.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Background: Depression and chronic inflammation are highly prevalent among individuals with spinal cord injury (SCI). Selective serotonin reuptake inhibitors (SSRIs) are the most prominently prescribed treatment strategy. While SSRIs can provide alleviation of symptoms for some patients, they are also associated with side-effects, and high rates of ineffectiveness/relapse. Due to the shortcomings of current treatments, it is critical to better understand factors which contribute to depressive symptoms and explore novel treatment modalities to improve outcomes for individuals with SCI and depression. Growing evidence suggests chronic inflammation plays a substantial role in the development of depression. Prior research from our lab has demonstrated this in SCI, as well as the efficacy of anti-inflammatory diets and exercise as treatments. However, adherence to these interventions over the long-term is challenging. Intermittent fasting (IF) has been shown to induce anti-inflammatory and anti-depressant effects in able-bodied individuals, and may be less burdensome, but its impact has not been evaluated in SCI. Further, behavioural support techniques such as education, ongoing tailored feedback and encouragement, self monitoring tools, and goal setting may help to further facilitate adherence to this less burdensome intervention strategy making it a more viable treatment long-term treatment option.

Objective/Hypothesis: The overall objective of this pilot study is to assess whether intermittent fasting combined with behavioral support techniques can provide a safe and feasible means of improving symptoms of depression in individuals with spinal cord injury (SCI) in comparison to an intermittent fasting only condition and explore the underlying mechanisms of action. This pilot will provide effect sizes to allow for a sample size calculation, and will assess the utility of implementing behavioral support techniques for a future larger scale RCT.

Methods: An RCT will be conducted involving 32 participants with mild to moderate depression recruited from the SCI outpatient program at Parkwood Institute. Participants will be randomly assigned to either the IF + support group or IF only group. The IF intervention will be performed by both groups over a period of 8-weeks whereby participants will fast daily (16-hour fast / 8-hour ad-libitum). The IF + support group will be provided with a smartphone app to provide behavioural support techniques, while the IF only group will not receive additional support. Outcome measures will be assessed at baseline and post intervention. The primary outcome measures will be changes in symptoms of depression and adherence to the intervention. Secondary outcomes will include safety, and change in inflammation and related pathways.

Significance: IF may provide a safe and feasible intervention to improve symptoms of depression following SCI. The addition of simple behavioral support techniques may enhance adherence further. The low burden and cost-free nature of this intervention may make it a more suitable long-term ant-inflammatory treatment strategy for depression for individuals with SCI.

Eligibility criteria: Inclusion Criteria:

1. Chronic (≥1 year post) SCI of any level or severity
2. 18 years of age or older
3. mild to moderate scores of depression based on the Structured Clinical Interview for DSM-5 (SCID) by clinical psychologist
4. stable dose of depression medications

Exclusion Criteria:

1. currently using anti-inflammatory medications
2. variable dosages of depression / anxiety medications
3. currently using anticoagulant medications
4. people with diabetes
5. women who are pregnant or attempting to become pregnant
6. current wound/infection
7. people with suicidal ideation
8. history of eating disorder
9. prior diagnosis of cardiovascular disease

Primary outcomes:
measure: Change in Symptoms of Depression
timeFrame: 8 weeks
measure: Program Adherence Rates
timeFrame: 8 weeks
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events During Intervention
timeFrame: 8 weeks
measure: Anxiety
timeFrame: 8 weeks
measure: Change in Plasma Cytokines
timeFrame: 8 weeks
measure: Change in Plasma Kynurenines
timeFrame: 8 weeks
Other outcomes:
Locations:
city: London
country: Canada
facility: Parkwood Institute, St Joseph's Health Care London
state: Ontario
Study officials:
affiliation: Lawson Research Institute
name: David J Allison, PhD.
role: PRINCIPAL_INVESTIGATOR
References: