NCT06188754

Healthy Lifestyles for Bipolar Disorder

Time-restricted Eating vs. Mediterranean Diet as Adjunctive Interventions for Bipolar Disorder

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: University of California, Berkeley · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Time Restricted Eating
• Diet, Mediterranean

Interventions

Type	Name	Description
BEHAVIORAL	Time restricted eating	Limiting food intake to 10 hours per day
BEHAVIORAL	Mediterranean diet	Dietary advice designed to improve consumption of vegetables, fruits, whole grains, and the use of olive oil.

Timeline

• Start date: 2024-06-05
• Primary completion: 2028-12-28
• Completion: 2029-02-28
• First posted: 2024-01-03
• Last updated: 2025-02-06

Locations

1 site across 1 country: United States