Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06560957
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-12
Brief Title:
SYNCED - SYNChronized Eating in Bipolar Depression Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility and Acceptability of Adjunctive Time Restricted Eating in Bipolar Disorder A Pilot Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Bipolar disorders BD are a group of complex disorders that impact mood behaviour and cognition and are known to cause significant suffering and impairment Circadian rhythm your internal daynight clock disruption which can involve changes in sleep-wake cycles frequently occurs in BD Both depression and mania are accompanied by circadian disruption These disruptions are hypothesized to lead to mood worsening metabolic dysfunction and inflammation If circadian dysfunction plays a significant role in the symptoms and trajectory of BD then treatment approaches that target these functions may lead to better outcomes One such approach is dietary interventions Time restricted eating TRE is a dietary tool that restricts the eating to an 8-12 hour window without changing diet quality or caloric intake Studies involving time restricted eating have been done in other conditions with promising results There have been no studies done for mood disorders in general or bipolar disorder specifically In this proposal the investigators will assess two dietary interventions TRE and nutritional counselling to examine how TRE may represent a safe and viable adjunct to traditional treatments The investigators aim to compare TRE with nutritional counselling while all participants continue to receive usual care Participants will receive support from a registered dietician and will be instructed on dietary habits Half of participants will receive nutritional counselling and half will be asked to do TRE Those in the TRE group will be asked to select a 10-hour window to consume all food and non-water beverages for the 8-week period Participants will be asked to complete a screening visit to determine eligibility and then will complete questionnaires at baseline week 4 and week 8 examining symptoms of their illness and cognition Participants will also provide a blood sample at baseline and week 8 for standard biochemistry tests pregnancy testing if applicable and to examine inflammatory markers Participants will also wear an actigraphy watch which provides wireless continuous monitoring of movements and ambient light The primary outcome is feasibility and acceptability do people agree to participate complete the study and follow the intervention what do they think of the intervention Secondary outcomes include changes in depression anxiety sleep and cognition Exploratory outcomes include inflammatory markers and circadian disruption
Detailed Description:
Given the lack of studies evaluating time restricted eating TRE this pilot study aims to examine the feasibility and acceptability of TRE as a prelude to a future multi-centre randomized controlled trial RCT evaluating efficacy If adjunctive TRE is found to be feasible this will pave the way for a novel and safe intervention which may have the potential to treat circadian dysfunction metabolic side effects and improve mood and cognitive outcomes in patients with BD
To evaluate the feasibility and acceptability of adjunctive 10-hour TRE with treatment as usual relative to nutritional counselling and treatment as usual for the treatment of depression associated with bipolar disorder To do this the investigators will estimate the rate proportion of eligible people who are willing to participate participants who drop out of the trial and participants who adhere to their allocated intervention
First the investigators hypothesize that the investigators would achieve our recruitment target of 40 patients with BD within the studys 18-month duration and retain at least 70 of participants through the follow-up period to evaluate feasibility The investigators will also be able to estimate what level of adherence could be expected following a single intervention with a 4-week reminder Second the investigators hypothesize that participants would complete the intervention and find it acceptable
Secondary Objectives To assess if TRE leads to meaningful reductions in markers of depression anxiety sleep quality of life and cognition
The investigators hypothesize a greater reduction in depressive symptoms anxiety symptoms compared to that seen in the control group The investigators also hypothesize improvements in sleep quality of life and cognition compared to the control group
Exploratory Objectives Effects on inflammatory markers and circadian disruption will be additionally explored
To evaluate the feasibility and acceptability of adjunctive 10-hour TRE with treatment as usual relative to nutritional counselling and treatment as usual for the treatment of depression associated with bipolar disorder To do this the investigators will estimate the rate proportion of eligible people who are willing to participate participants who drop out of the trial and participants who adhere to their allocated intervention
First the investigators hypothesize that the investigators would achieve our recruitment target of 40 patients with BD within the studys 18-month duration and retain at least 70 of participants through the follow-up period to evaluate feasibility The investigators will also be able to estimate what level of adherence could be expected following a single intervention with a 4-week reminder Second the investigators hypothesize that participants would complete the intervention and find it acceptable
Secondary Objectives To assess if TRE leads to meaningful reductions in markers of depression anxiety sleep quality of life and cognition
The investigators hypothesize a greater reduction in depressive symptoms anxiety symptoms compared to that seen in the control group The investigators also hypothesize improvements in sleep quality of life and cognition compared to the control group
Exploratory Objectives Effects on inflammatory markers and circadian disruption will be additionally explored
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None