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

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04586829

Collaborator

(none)

Enrollment

Location

Arms

13.5

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorders	Other: Diet	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

35 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomised controlled trialRandomised controlled trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 15, 2020

Anticipated Primary Completion Date :

Oct 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conventional diet Conventional diet. (50% carbohydrate, 30% lipids, 20% protein). Current dietary recommendations from official guidelines will be reinforced.	Other: Diet <50 grams of total carbohydrates per day. Monosaturated fats consumption will be encouraged over saturated fats.
Experimental: Ketogenic diet 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 <50 grams of total carbohydrates per day. Monosaturated fats consumption will be encouraged over saturated fats.

Arm

Intervention/Treatment

Active Comparator: Conventional diet

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

Other: Diet

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

Experimental: Ketogenic diet

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	INCMNSZ	Mexico City	Cdmx	Mexico	14080

Sponsors and Collaborators

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Investigators

Principal Investigator: Adrian Soto, MD,DPhil, Biomedical Sciences Researcher

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Luis Adrian Soto Mota, Principal Investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

ClinicalTrials.gov Identifier:

NCT04586829

Other Study ID Numbers:

UIE-3506-20-21-1

First Posted:

Oct 14, 2020

Last Update Posted:

Feb 10, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of Feb 10, 2021