Ketogenic Therapy Longitudinal Study

Our first cohort has begun! Enrollment for our study is currently paused and will resume in July of 2026, with a scheduled start, on or about September 1st, 2026.

We are looking for participant families with children between the ages of 6 – 20 diagnosed with a mood disorder, bipolar disorder, or other mental health condition to participate in a study investigating the effects of ketogenic therapy on mental health.

Participation in this study includes a comprehensive program to support the parents and caregivers whose families will be trying out this metabolic therapy, at no cost to families. 

Participant families must be willing to change their diet, keep a daily food diary, monitor blood glucose and ketones, track mental health symptoms each day, and participate in weekly zoom sessions.

If you have been thinking about trying ketogenic therapy for yourself or your child, this may be the perfect opportunity to have extra support from the CMHRC Team.

Frequently Asked Questions (FAQ)

Thank you so much for your interest in CMHRC’s longitudinal ketogenic therapy study. Below you will find answers to frequently asked questions. If you do not find the answer to your question, please contact us and we will get back to you with an answer within 2 business days.

What is ketogenic therapy?

Ketogenic therapy is a high fat food plan, balanced with protein, and limiting carbohydrates. This food plan helps the body to achieve and maintain a state of nutritional ketosis, which has been shown in studies with adults to help regulate mood. 

When will the study officially begin?

New study cohorts will begin every six months, with an intended start date of March 1st, 2026. We intend to begin screening potential participants in early 2026. 

When is the interest survey due?

We ask that you submit your interest survey to us as soon as you are able. Or contact us directly. Space is limited and the sooner you respond the sooner you will be able to reserve your spot.

Can we participate even if I or my child are already receiving mental health services such as therapy or psychiatric care?

Yes! Individuals and families who are receiving mental health services, such as therapy or psychiatric care, are eligible for both the study as well as the stand-alone program. 

All outside services including therapy and medication management will remain with your current care team. CMHRC will not provide medical care or oversight during this study. All medical decision making will remain with participants and their primary care physicians. 

Does the study offer any incentive for participating?

There is no monetary, or other form of, compensation for participating in this research project.

Research Participants Will Receive Access to the Following Services at No Cost:

    • The CMHRC Toolkit for symptom tracking
    • A Cronometer Gold subscription for logging food
    • A KetoMojo ketone and glucose monitoring device and all supplies
    • Withings Sleep mat
    • CMHRC Keto psychoeducation and support group sessions
    • Access to CMHRC professionals

The only fees families may encounter during the study are those associated with laboratory blood work testing. We will provide families with the list of laboratory tests for them to request from their primary care provider and they may use their insurance plan to help with the expense. 

Will we be able to participate even if there are additional people living in our home?

Yes! Any household size or configuration can participate in the study. Some families may choose to have the entire family eat within the ketogenic guidelines while for others only one or two members of the family will follow the food plan. You can think of the changes similarly to how meals might be modified to accommodate a family member with an allergy. For example, some families with lactose intolerance choose to be a lactose free home while other families focus more on preparing lactose free family meals and educating the child with the allergy to avoid foods in the house that will cause an allergic reaction.

Whatever you decide, we will be here to support you as you make these modifications in the way that works best for your family. 

What about a fear of needles? Is it possible to have them participate in the study?

Yes! Blood ketone and glucose monitoring is a necessary safety measure when following ketogenic therapy and participants will have their blood tested with a small finger prick via lancet once a day. But, there are no needles and you don’t have to use that word when talking with those who dislike needles. The lancet is in a covered case and the sharp tip is not visible. The lancet device has 5 pressure settings allowing you to customize the pressure to just the right level. Washing hands in warm soapy water for 30 seconds will help to soften the skin and bring the blood to the surface of the fingertip. This reduces much of the discomfort.

I have heard that ketogenic diets make mental health symptoms worse. How will the study support us in case of adverse effects?

Current research indicates that adverse effects are typically due to a phenomenon called “Keto Flu” or increased sensitivity to medications. Our study protocol is designed to ease participants into ketosis slowly to avoid potential adverse effects and to improve adherence to the food plan.

In addition, study participants will have  access to the program staff via text, phone, and email. Urgent messages will be returned within 24 hours and non-urgent messages will be returned within 2 business days. CMHRC will not provide medical care or oversight during this study/program. All medical decision making will remain with participants and their primary care physicians.

Do we have to use our insurance to get the KetoMojo device?

No. Study participants will receive the KetoMojo device, lancets, lancing device, ketone strips, glucose strips, and alcohol prep pads. They will be shipped directly to study participants at no cost. All of these costs are covered by the funding of the study.

Can we participate even if we don’t have an official mental health diagnosis?

Yes! We welcome any one between the ages of 6 -20 with symptoms consistent with a mood disorder to apply to participate in the study. During the screening process, you will be given information on mental health disorders and CMHRC clinicians will work with you to determine if they are consistent with the study eligibility guidelines.

Anyone who does not meet the study guidelines for participation will be offered a spot in our separate fee-for-service program.

If a study participant is hospitalized during the study will they be removed from the study?

No, no one will not be automatically removed from the study due to hospitalization. Program staff must be notified of the hospitalization because daily data during that period will not be able to be collected. It is also likely the participant will not be able to remain in ketosis during a hospitalization, and that is okay. Caregivers will continue to attend all the community support and psychoeducation sessions during that time. We will support the participant in reintroducing the ketogenic therapy food plan when they return home. 

Will there be a way for members of the study to communicate with each other between support group meetings and psychoeducation sessions?

Yes! We will provide access to a private and unsearchable Facebook group for study participants that will be monitored by study staff. This FB group will be a protected way for program participants to communicate, share resources, support one another, and document challenges during program participation. Access to this group and content there will be limited to study participants and related topics only.

What will participants be asked to do during the study?

    • Complete a baseline period of 14 days without any dietary changes
    • Follow a ketogenic food plan for 2 years
    • Participate follow-up meetings 4 times per year for an additional 5 years
    • Record and share data on ketone and glucose levels, food eaten, and symptoms. 

We do not expect perfection! This is a scientific inquiry and we want to know how feasible adopting ketogenic therapy at home is for families and if it changes symptoms. Honest reactions to the food plan changes and to the study requirements will be valued information for the study to collect.

What will caregivers be asked to do during the program?

Caregiver obligations will change depending upon the participants age and level of independence. In the case of someone who needs significant assistance the caregiver will be asked to:

    • Keep a daily food journal for the participant
    • Track daily symptom presentation
    • Collect blood glucose and ketone levels from the participant via finger prick once per day
    • Attend weekly community support and psychoeducation sessions via Zoom with CMHRC staff
    • Complete quarterly symptom surveys

What kind of topics will be covered in the psychoeducation sessions via Zoom with CMHRC staff?

You can expect psychoeducation sessions to include topics such as:

    • The unique symptom presentation of bipolar disorder in childhood and adolescence
    • Traditional treatment interventions for bipolar disorder
    • Insulin resistance and its impacts on physical and mental health
    • The science behind the ketogenic diet
    • Ketogenic diet macros, macro ratios, and healthy fats
    • And much more!

What kind of topics will be covered in the community support sessions via Zoom with CMHRC staff?

You can expect support groups to include topics such as:

    • Meal planning & grocery shopping
    • Recipe sharing & conversions
    • Diet adherence in the community
      • i.e. school, visiting relatives, restaurants, travel
    • Problem solving
    • Emotional support
    • And much more!

If you have any questions that were not answered here, please contact us and we’ll get back to you as soon as we can.

We are grateful to Baszucki Group for their support and commitment to championing the potential of metabolic therapies. We also deeply appreciate their recognition of CMHRC’s as an organization that can carry out this study while providing resources, support, and guidance to families. This significant funding allows us to further our mission to provide vital support and resources to children and families facing mental illness.