Anxiety DisordersNCT04586829
The Effect of Two Dietary Interventions on the Symptomatic Control of People Living With Anxiety Disorders.
A study testing Diet in people with Anxiety Disorders, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteMexico
- Study dates
- 15 Oct 2020to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a confirmed diagnosis of Anxiety Disorder by Psychiatrist.
Who cannot join
- Patients with the diagnosis of drug abuse, cognitive impairment or dementia, porphyria, carnitine translocase deficiency and carnitine palmitoyl transferase deficiency.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Anxiety Disorders
- Being tested
- Diet
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
<50 grams of total carbohydrates per day. Monosaturated fats consumption will be encouraged over saturated fats.
| Study group | Role | What they receive |
|---|---|---|
| Conventional diet | Active comparator | Conventional diet. (50% carbohydrate, 30% lipids, 20% protein). Current dietary recommendations from official guidelines will be reinforced. Receives: Other: Diet |
| 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. Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom control
Total points in Beck's Inventory for Anxiety. Scores range between 0 to 63 and higher numbers mean a worse outcome.
Measured: One month
Secondary outcomes (1)
Subjective self perceived control
Self-assessed and reported symptom ranging between 0 - 100. Higher numbers mean a better outcome.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start15 Oct 2020
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Adrian Soto Mota, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Investigators
- Adrian Soto, MD,DPhil, Principal investigator, Biomedical Sciences Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586829
- Sponsor's protocol ID
- UIE-3506-20-21-1
- Status last verified
- Oct 2022
- First submitted
- 5 Oct 2020
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request to PI.
Publications
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.
PubMed 28210213Fydrich, 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.
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.
PubMed 23276384Kovacs 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.
PubMed 31178772Saslow 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.
PubMed 29269731Sheehan 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.
PubMed 9881538
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Dietary Interventions on the Symptomatic Control of People Living With Anxiety Disorders.
- ClinicalTrials.gov ID
- NCT04586829
- Acronym / sponsor ID
- UIE-3506-20-21-1
- Conditions
- Anxiety Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Conventional diet | Active comparator | Other: DietConventional diet. (50% carbohydrate, 30% lipids, 20% protein). Current dietary recommendations from official guidelines will be reinforced. |
| Ketogenic diet | Experimental | Other: DietTailored ketogenic diet. Participants will be allowed to chose their meals as long as they consume less than 50gr of carbohydrates per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a confirmed diagnosis of Anxiety Disorder by Psychiatrist.
Key exclusion criteria (1 listed)
- Patients with the diagnosis of drug abuse, cognitive impairment or dementia, porphyria, carnitine translocase deficiency and carnitine palmitoyl transferase deficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet<50 grams of total carbohydrates per day. Monosaturated fats consumption will be encouraged over saturated fats. | Other | Conventional diet, Ketogenic diet |
Primary outcome
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.
1 secondary outcome
Subjective self perceived control
Time frame: One month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Background: PubMed 28210213Ari 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.
- BackgroundFydrich, 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.
- Background: PubMed 23276384Kashiwaya 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.
- Background: PubMed 31178772Kovacs 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.
- Background: PubMed 29269731Saslow 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.
- Background: PubMed 9881538Sheehan 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.
- Individual participant dataSharing planned: Yes. Upon request to PI.
Related trials for Anxiety Disorders
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian Soto, MD,DPhil principal investigator
Biomedical Sciences Researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet in people with Anxiety Disorders, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom control (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04586829, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2022.