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

Not Applicable

• Conditions: Anxiety Disorders
• Interventions: Other: Diet

• Registration Number: NCT04586829
• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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.

Study Timeline

• Study First Submitted: 2020-10-05
• Study First Submitted QC: 2020-10-09
• Study First Posted: 2020-10-14
• Study Start: 2020-10-15
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-17
• Last Update Posted: 2022-10-18
• Primary Completion: 2024-10-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional diet	Diet	Conventional diet. (50% carbohydrate, 30% lipids, 20% protein). Current dietary recommendations from official guidelines will be reinforced.
Ketogenic diet	Diet	Tailored ketogenic diet. Participants will be allowed to chose their meals as long as they consume less than 50gr of carbohydrates per day.

Primary Outcome Measures

Name	Time	Method
Symptom control	One month	Total points in Beck's Inventory for Anxiety. Scores range between 0 to 63 and higher numbers mean a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Subjective self perceived control	One month	Self-assessed and reported symptom ranging between 0 - 100. Higher numbers mean a better outcome.

Trial Locations

Locations (1)

INCMNSZ; 🇲🇽 Mexico City, Cdmx, Mexico