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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional diet | Active Comparator | Conventional diet. (50% carbohydrate, 30% lipids, 20% protein). Current dietary recommendations from official guidelines will be reinforced. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet | Other | <50 grams of total carbohydrates per day. Monosaturated fats consumption will be encouraged over saturated fats. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective self perceived control | Self-assessed and reported symptom ranging between 0 - 100. Higher numbers mean a better outcome. | One month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrian Soto, MD,DPhil | Biomedical Sciences Researcher | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INCMNSZ | Mexico City | Mexico City | 14080 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28210213 | Background | 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. | |
| Background | 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. | ||
| 23276384 |
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Upon request to PI.
One year after publication
Send email to adrian.sotom@incmnsz.mx
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Randomised controlled trial
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| 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. |
| 31178772 | Background | 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. |
| 29269731 | Background | 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. |
| 9881538 | Background | 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. |