Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06188754
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2023-12-18
Brief Title:
Healthy Lifestyles for Bipolar Disorder
Sponsor:
University of California Berkeley
Organization:
University of California Berkeley
Study Overview
Official Title:
Time-restricted Eating vs Mediterranean Diet as Adjunctive Interventions for Bipolar Disorder
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HL
Brief Summary:
The goal of this clinical trial is to compare the effects of two different healthy lifestyles on outcomes for those with bipolar disorder The goals are to understand the acceptability of time-restricted eating and the mediterranean diet for those who are already receiving medication treatment for bipolar disorder and to consider how these two food plans predict changes in manic symptoms depressive symptoms and Quality of Life Participants will complete daily measures of eating sleep and mood for two weeks and then will be assigned to follow one of the two food plans for eight weeks The investigators will measure symptoms and Quality of Life at baseline and during and after the food plan
Detailed Description:
The investigators will conduct a randomized controlled trial RCT to examine the effects of time-restricted eating as compared to the mediterranean diet In time-restricted eating TRE participants will be asked to limit their food intake to a period of 10 hours per day In the mediterranean diet participants will be asked to follow a food plan that emphasizes vegetables fruit whole grains and olive oil as central dietary components The investigators aim to test both food plans as additions to standard medication approaches in bipolar disorder Participants who are receiving medical treatment for bipolar disorder and who report at least some sleep or circadian problems will complete baseline measures and then will be randomly assigned to TRE or the mediterranean diet for 8 weeks and then will complete measures of symptoms Quality of Life and possible treatment mechanisms at the end of treatment and at 3 6 and 12 months after the intervention If successful this work will provide a novel easily implemented and highly acceptable intervention for BD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None