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Clinical Trials/NCT04586829
NCT04586829
Enrolling By Invitation
Not Applicable

The Effect of Two Dietary Interventions on the Symptomatic Control of People Living With Anxiety Disorders.

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran1 site in 1 country35 target enrollmentOctober 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety Disorders
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Enrollment
35
Locations
1
Primary Endpoint
Symptom control
Status
Enrolling By Invitation
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 15, 2020
End Date
December 1, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Responsible Party
Principal Investigator
Principal Investigator

Luis Adrian Soto Mota

Principal Investigator

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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.

Outcomes

Primary Outcomes

Symptom control

Time Frame: One month

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

Secondary Outcomes

  • Subjective self perceived control(One month)

Study Sites (1)

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