Intermittent Fasting for Inflammation and Depression in Spinal Cord Injury

NCT06807528 | Not Yet Recruiting

• 1 other identifier: 15564
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury; Depression - Major Depressive Disorder

Keywords

spinal cord injury; inflammation; depression; intermittent fasting

Outcome Measures

Primary Outcomes (2)

• Change in Symptoms of Depression

  This study will assess changes in symptoms of depression (over 8-weeks) in response to the intermittent fasting + behavioral support techniques condition compared to an intermittent fasting only condition as measured by the patient health questionnaire-9 (PHQ-9). The PHQ-9 has been shown to be a valid assessment for major depressive disorder in individuals with SCI. The PHQ-9 is a 9-item questionnaire with items pertaining to feelings over the previous 2-weeks. Each item is scored on a scale from 0 ("not at all") to 3 ("nearly every day") with total scores allowing for assessment of depression severity. A score ranging from 0-4 suggests "none-minimal" depression severity, 5-9 suggests mild depression severity, 10-14 suggests moderate depression severity, 15-19 suggests moderately severe depression severity, and 20-27 suggests severe depression severity. A PHQ-9 score ≥ 10 has a sensitivity of 88% and a specificity of 88% for major depression.

  8 weeks

• Program Adherence Rates

  Adherence will be assessed to examine how well participants in the intermittent fasting + behavioral support techniques condition adheres to the protocol compared to the intermittent fasting only condition. Adherence will be assessed based on self-reported eating times to determine the number of days participants in each group successfully adhered to the fasting condition. Specifically, days where participants performed the full 16 hour fasting window will be considered 'Adherent'. Days where participants do not perform the full 16 hour fasting window will be considered "Non-adherent'. Daily adherence percentage will be calculated based on the number of days participants were adherent divided by the total number of days of the intervention multiplied by 100.

  8 weeks

Secondary Outcomes (4)

• Incidence of Treatment-Emergent Adverse Events During Intervention

  8 weeks

• Anxiety

  8 weeks

• Change in Plasma Cytokines

  8 weeks

• Change in Plasma Kynurenines

  8 weeks

Study Arms (2)

Intermittent Fasting + Behavioral Support Strategies

EXPERIMENTAL

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

Behavioral: Intermittent fasting; Behavioral: Behavioral Support Strategies

Intermittent Fasting Only

ACTIVE COMPARATOR

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.

Behavioral: Intermittent fasting

Interventions

Intermittent fasting BEHAVIORAL

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.

Intermittent Fasting + Behavioral Support Strategies; Intermittent Fasting Only

Behavioral Support Strategies BEHAVIORAL

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.

Intermittent Fasting + Behavioral Support Strategies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• currently using anti-inflammatory medications
• variable dosages of depression / anxiety medications
• currently using anticoagulant medications
• people with diabetes
• women who are pregnant or attempting to become pregnant
• current wound/infection
• people with suicidal ideation
• history of eating disorder
• prior diagnosis of cardiovascular disease

Sponsors & Collaborators

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

Study Sites (1)

Parkwood Institute, St Joseph's Health Care London

London, Ontario, N6C 0A7, Canada

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Inflammation; Depression; Intermittent Fasting

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Fasting; Feeding Behavior

Study Officials

• David J Allison, PhD.

  Lawson Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David J Allison, PhD.

CONTACT

519 646 6100; David.Allison@sjhc.london.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 4, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)