Evidence map›Paper›PMID 38762486›Full record

ArticleBMC psychiatry2024

A randomized controlled trial to compare the effects of time-restricted eating versus Mediterranean diet on symptoms and quality of life in bipolar disorder.

Sheri L Johnson, Greg Murray, Lance J Kriegsfeld, Emily N C Manoogian, Liam Mason, J D Allen, Michael Berk, Satchidanda Panda, Nandini A Rajgopal, Jake C Gibson and 3 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC psychiatry, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06188754 (Time-restricted Eating vs. Mediterranean Diet as Adjunctive Interventions for Bipolar Disorder), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06188754 narecruitingnot on this map

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

TypeinterventionalSponsorUniversity of California, BerkeleyRan2024 to 2029Enrolled300ConditionsTime Restricted Eating, Diet, MediterraneanArmsTime restricted eating, Mediterranean diet
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Sheri L JohnsonDepartment of Psychology, University of California, Berkeley, USA. sljohnson@berkeley.edu.
Greg MurrayCentre for Mental Health, Swinburne University, Melbourne, VIC, 3122, Australia.
Lance J KriegsfeldDepartment of Psychology, University of California, Berkeley, USA.
Emily N C ManoogianRegulatory Biology, Salk Institute for Biological Studies, La Jolla, CA, 92037, USA.
Liam MasonResearch Department of Clinical, Educational and Health Psychology, University College London, London, UK.
J D AllenDepartment of Psychology, University of California, Berkeley, USA.
Michael BerkSchool of Medicine, Deakin University, Geelong, VIC, Australia.
Satchidanda PandaRegulatory Biology, Salk Institute for Biological Studies, La Jolla, CA, 92037, USA.
Nandini A RajgopalDepartment of Psychology, University of California, Berkeley, USA.
Jake C GibsonDepartment of Psychology, University of California, Berkeley, USA.
Keanan J JoynerDepartment of Psychology, University of California, Berkeley, USA.
Robert VillanuevaDepartment of Psychology, University of California, Berkeley, USA.
Erin E MichalakDepartment of Psychiatry, University of British Columbia, Vancouver, BC, Canada.

Funding

Wellcome Trust 227087Wellcome Trust 227087/Z/23/Z
6 · The paper itself

Abstract

backgroundThe primary objective of this randomized controlled trial (RCT) is to establish the effectiveness of time-restricted eating (TRE) compared with the Mediterranean diet for people with bipolar disorder (BD) who have symptoms of sleep disorders or circadian rhythm sleep-wake disruption. This work builds on the growing evidence that TRE has benefits for improving circadian rhythms. TRE and Mediterranean diet guidance will be offered remotely using self-help materials and an app, with coaching support.

methodsThis study is an international RCT to compare the effectiveness of TRE and the Mediterranean diet. Three hundred participants will be recruited primarily via social media. Main inclusion criteria are: receiving treatment for a diagnosis of BD I or II (confirmed via DIAMOND structured diagnostic interview), endorsement of sleep or circadian problems, self-reported eating window of ≥ 12 h, and no current mood episode, acute suicidality, eating disorder, psychosis, alcohol or substance use disorder, or other health conditions that would interfere with or limit the safety of following the dietary guidance. Participants will be asked to complete baseline daily food logging for two weeks and then will be randomly allocated to follow TRE or the Mediterranean diet for 8 weeks, during which time, they will continue to complete daily food logging. Intervention content will be delivered via an app. Symptom severity interviews will be conducted at baseline; mid-intervention (4 weeks after the intervention begins); end of intervention; and at 6, 9, and 15 months post-baseline by phone or videoconference. Self-rated symptom severity and quality of life data will be gathered at those timepoints, as well as at 16 weeks post baseline. To provide a more refined index of whether TRE successfully decreases emotional lability and improves sleep, participants will be asked to complete a sleep diary (core CSD) each morning and complete six mood assessments per day for eight days at baseline and again at mid-intervention. DISCUSSION: The planned research will provide novel and important information on whether TRE is more beneficial than the Mediterranean diet for reducing mood symptoms and improving quality of life in individuals with BD who also experience sleep or circadian problems.

trial registrationClinicalTrials.gov ID NCT06188754.

Indexed as

Bipolar DisorderDiet, MediterraneanQuality of LifeAdultCircadian RhythmFemaleHumansMaleRandomized Controlled Trials as TopicSleep Wake DisordersBipolar disorderCircadianDepressionManiaMediterranean dietQuality of lifeRandomized controlled trialTime-restricted eating

Identifiers

PMID38762486
PMCPMC11102174

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.