NCT04586829

Brief Summary

This randomised controlled trial will evaluate the effect of a ketogenic diet vs a conventional diet on the symptoms of patients living with anxiety disorders using a validate self-reported inventory.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

October 15, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

October 18, 2022

Status Verified

October 1, 2022

Enrollment Period

4 years

First QC Date

October 5, 2020

Last Update Submit

October 17, 2022

Conditions

Anxiety Disorders

Outcome Measures

Primary Outcomes (1)

  • Symptom control

    Total points in Beck's Inventory for Anxiety. Scores range between 0 to 63 and higher numbers mean a worse outcome.

    One month

Secondary Outcomes (1)

  • Subjective self perceived control

    One month

Study Arms (2)

Conventional diet

ACTIVE COMPARATOR

Conventional diet. (50% carbohydrate, 30% lipids, 20% protein). Current dietary recommendations from official guidelines will be reinforced.

Other: Diet

Ketogenic diet

EXPERIMENTAL

Tailored ketogenic diet. Participants will be allowed to chose their meals as long as they consume less than 50gr of carbohydrates per day.

Other: Diet

Interventions

DietOTHER

\<50 grams of total carbohydrates per day. Monosaturated fats consumption will be encouraged over saturated fats.

Conventional dietKetogenic diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a confirmed diagnosis of Anxiety Disorder by Psychiatrist.

You may not qualify if:

  • Patients with the diagnosis of drug abuse, cognitive impairment or dementia, porphyria, carnitine translocase deficiency and carnitine palmitoyl transferase deficiency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INCMNSZ

Mexico City, Mexico City, 14080, Mexico

Location

Related Publications (6)

  • Ari C, Kovacs Z, Juhasz G, Murdun C, Goldhagen CR, Koutnik AP, Poff AM, Kesl SL, D'Agostino DP. Corrigendum: Exogenous Ketone Supplements Reduce Anxiety-Related Behavior in Sprague-Dawley and Wistar Albino Glaxo/Rijswijk Rats. Front Mol Neurosci. 2017 Feb 13;10:36. doi: 10.3389/fnmol.2017.00036. eCollection 2017.

    PMID: 28210213BACKGROUND

  • Fydrich, T., Dowdall, D. and Chambless, D. L. (1992) 'Reliability and validity of the beck anxiety inventory', Journal of Anxiety Disorders, 6(1), pp. 55-61. doi: 10.1016/0887-6185(92)90026-4.

    BACKGROUND

  • Kashiwaya Y, Bergman C, Lee JH, Wan R, King MT, Mughal MR, Okun E, Clarke K, Mattson MP, Veech RL. A ketone ester diet exhibits anxiolytic and cognition-sparing properties, and lessens amyloid and tau pathologies in a mouse model of Alzheimer's disease. Neurobiol Aging. 2013 Jun;34(6):1530-9. doi: 10.1016/j.neurobiolaging.2012.11.023. Epub 2012 Dec 29.

    PMID: 23276384BACKGROUND

  • Kovacs Z, D'Agostino DP, Diamond D, Kindy MS, Rogers C, Ari C. Therapeutic Potential of Exogenous Ketone Supplement Induced Ketosis in the Treatment of Psychiatric Disorders: Review of Current Literature. Front Psychiatry. 2019 May 23;10:363. doi: 10.3389/fpsyt.2019.00363. eCollection 2019.

    PMID: 31178772BACKGROUND

  • Saslow LR, Daubenmier JJ, Moskowitz JT, Kim S, Murphy EJ, Phinney SD, Ploutz-Snyder R, Goldman V, Cox RM, Mason AE, Moran P, Hecht FM. Twelve-month outcomes of a randomized trial of a moderate-carbohydrate versus very low-carbohydrate diet in overweight adults with type 2 diabetes mellitus or prediabetes. Nutr Diabetes. 2017 Dec 21;7(12):304. doi: 10.1038/s41387-017-0006-9.

    PMID: 29269731BACKGROUND

  • Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.

    PMID: 9881538BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Diet

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Adrian Soto, MD,DPhil

    Biomedical Sciences Researcher

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 5, 2020

First Posted

October 14, 2020

Study Start

October 15, 2020

Primary Completion

October 1, 2024

Study Completion

December 1, 2024

Last Updated

October 18, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

Upon request to PI.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
One year after publication
Access Criteria
Send email to adrian.sotom@incmnsz.mx

Locations

ME(1)