Back to resultsThe Effect of Two Dietary Interventions on the Symptomatic Control of People Living With Anxiety Disorders.
Primary Purpose
Anxiety Disorders
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Diet
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Disorders
Eligibility Criteria
Inclusion Criteria:
- Patients with a confirmed diagnosis of Anxiety Disorder by Psychiatrist.
Exclusion Criteria:
- Patients with the diagnosis of drug abuse, cognitive impairment or dementia, porphyria, carnitine translocase deficiency and carnitine palmitoyl transferase deficiency.
Sites / Locations
- INCMNSZ
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional diet
Ketogenic diet
Arm Description
Conventional diet. (50% carbohydrate, 30% lipids, 20% protein). Current dietary recommendations from official guidelines will be reinforced.
Tailored ketogenic diet. Participants will be allowed to chose their meals as long as they consume less than 50gr of carbohydrates per day.
Outcomes
Primary Outcome Measures
Symptom control
Total points in Beck's Inventory for Anxiety. Scores range between 0 to 63 and higher numbers mean a worse outcome.
Secondary Outcome Measures
Subjective self perceived control
Self-assessed and reported symptom ranging between 0 - 100. Higher numbers mean a better outcome.
Full Information
NCT ID
NCT04586829
First Posted
October 5, 2020
Last Updated
October 17, 2022
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
1. Study Identification
Unique Protocol Identification Number
NCT04586829
Brief Title
The Effect of Two Dietary Interventions on the Symptomatic Control of People Living With Anxiety Disorders.
Official Title
The Effect of Two Dietary Interventions on the Symptomatic Control of People Living With Anxiety Disorders.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
It has been theorized that ketogenic diet could improve symptom control in patients living with anxiety disorders. Animal models support this hypothesis but to this date, studies in humans are lacking.
The investigators will randomise patients with a confirmed diagnosis of anxiety disorders to follow a ketogenic diet (<50 grs of carbohydrate per day) or a conventional diet (50% carbohydrate, 30% lipids, 20% protein) for one month.
Symptom control will be assessed weekly using Beck's inventory for Anxiety. Diet adherence will be measured using standardised food frequency logs and acetoacetate urine strips.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional diet
Arm Type
Active Comparator
Arm Description
Conventional diet. (50% carbohydrate, 30% lipids, 20% protein). Current dietary recommendations from official guidelines will be reinforced.
Arm Title
Ketogenic diet
Arm Type
Experimental
Arm Description
Tailored ketogenic diet. Participants will be allowed to chose their meals as long as they consume less than 50gr of carbohydrates per day.
Intervention Type
Other
Intervention Name(s)
Diet
Intervention Description
<50 grams of total carbohydrates per day. Monosaturated fats consumption will be encouraged over saturated fats.
Primary Outcome Measure Information:
Title
Symptom control
Description
Total points in Beck's Inventory for Anxiety. Scores range between 0 to 63 and higher numbers mean a worse outcome.
Time Frame
One month
Secondary Outcome Measure Information:
Title
Subjective self perceived control
Description
Self-assessed and reported symptom ranging between 0 - 100. Higher numbers mean a better outcome.
Time Frame
One month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with a confirmed diagnosis of Anxiety Disorder by Psychiatrist.
Exclusion Criteria:
Patients with the diagnosis of drug abuse, cognitive impairment or dementia, porphyria, carnitine translocase deficiency and carnitine palmitoyl transferase deficiency.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Soto, MD,DPhil
Organizational Affiliation
Biomedical Sciences Researcher
Official's Role
Principal Investigator
Facility Information:
Facility Name
INCMNSZ
City
Mexico City
State/Province
Cdmx
ZIP/Postal Code
14080
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Upon request to PI.
IPD Sharing Time Frame
One year after publication
IPD Sharing Access Criteria
Send email to adrian.sotom@incmnsz.mx
Citations:
PubMed Identifier
28210213
Citation
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.
Results Reference
background
Citation
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.
Results Reference
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PubMed Identifier
23276384
Citation
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.
Results Reference
background
PubMed Identifier
31178772
Citation
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.
Results Reference
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PubMed Identifier
29269731
Citation
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.
Results Reference
background
PubMed Identifier
9881538
Citation
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.
Results Reference
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The Effect of Two Dietary Interventions on the Symptomatic Control of People Living With Anxiety Disorders.
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