About Our Study

The purpose of this study is to see whether a 16-week ketogenic diet added to standard clinic care is acceptable to youth with bipolar disorder and associated with improvements in their mood and health.

Youth with or at risk for bipolar disorder often have challenges with their mood and functioning even when receiving recommended psychiatric treatments. We need more effective and comprehensive ways to support these young people and their families. With this study, we hope to learn more about the role of diet and nutrition in the treatment of youth with bipolar disorder. In particular, we are examining whether combining a ketogenic diet with standard psychiatric care is acceptable and associated with improvements in mental and physical health.

More about the Keto Diet

The ketogenic diet is a high-fat, low-carbohydrate, and moderate-protein diet. This diet shifts the body’s metabolic state from using primarily carbohydrates to fats for energy. This shift results in the production of ketones, which can be measured with a simple blood test.

There is growing evidence that ketogenic diets are associated with mood improvement in adults with bipolar disorder, but this diet has not yet been systematically tested in adolescents or young adults with bipolar disorder.

Ketone Monitoring and Meal Plan

During the 16-week diet, participants will have the option of receiving complementary fresh, fridge-ready keto-friendly meals through our partner delivery service Factor 75. Participants can order up to 14 meals per week. If participants prefer to buy and cook foods on your own, at least some days of the week, they will be compensated up to $28/day for groceries.

In this study, ketones (and blood sugar) will be monitored throughout the 16-week diet with an at-home finger-prick meter, similar to those used for monitoring diabetes. A study dietitian will work closely with participants to help them adjust to cooking and eating foods compliant with a ketogenic diet during the course of the study.

Participants will also get:

Education and Coaching: If eligible for the study, you will work with a therapist to help you (and your family) consider your goals and motivation for starting ketogenic therapy, explore challenges associated with the diet and how you might work with your family and treatment team to overcome them.

16-Week Keto Diet with Dietitian Support: A study dietitian will help you (and your family) learn more about how to start and maintain the ketogenic diet, provide guidance around cooking and grocery shopping, and monitor any reactions to the diet through weekly to biweekly dietitian coaching sessions. Dietitian sessions occur via Telehealth.

Keto Meter Testing: During the diet, you will be asked to take a daily self-administered blood test (finger-prick) using a “Keto Mojo” meter provided to you, which will monitor your ketone and blood glucose levels.

Follow up psychiatrist and research visits: You will meet with a study psychiatrist at least monthly during the course of the study. You will be asked to complete certain labs (blood and urine tests) prior to and after the 16-week diet so that your team can track your health and response to the diet. You will also be asked to participate in research assessments prior to, during, and after the diet. These assessments consist of interviews, questionnaires, and brief assessments of your mental health symptoms, thinking skills and overall functioning.

STudy DUration

Our 4-5 Month Study Involves Four Phases:

1

Phase 1: Eligibility Check

We will check to see if the diet is safe for you by asking you to complete a diagnostic evaluation, provide a blood and urine sample, and meet with a dietitian who will ask questions about your health, diet and mood.

2

Phase 2: Diet Ramp-Up Period

You will meet with a dietitian and our study team to learn more about the keto diet and discuss your motivation for starting the diet. You’ll receive support from our dietitian to gradually incorporate keto meals (starting with one meal a day). We will also complete a pre-diet research visit to assess your mood symptoms.

3

Phase 3: Keto Diet for 16 weeks

You will receive keto meals delivered to you or money to make your own keto meals. We will ask you to meet weekly with a dietitian online and check in monthly with both the study psychiatrist and the research team. You will be asked to provide daily blood tests (finger-pricks) using the Keto Mojo meter.

4

Phase 4: Post Diet Research Visits

We will ask you to provide another blood sample and answer questions about your mood and health. You will meet with the dietitian and psychiatrist on your treatment team and receive support wrapping up your participation in the study.

More about us

Frequently Asked Questions

What are the responsibilities of a parent/relative of a young participant?

Throughout the study, relative(s) or caregivers(s) are asked to support you on your diet and help you monitor any dietary side effects or other concerns. They are asked to participate in your research assessments and parts of your sessions with the dietitian, psychologist and psychiatrist (required for minors under age 18). They are also asked to help you (as needed) prepare and receive keto meals and do at-home blood tests. Your relatives are not expected to keep to the same keto diet as you, but they may choose to do so. For youth over 18, the participation of an adult relative is encouraged but not required.

What are the benefits of participating in this study?

You will receive a psychiatric evaluation from experts in mood disorders.
You may receive a more definitive diagnosis or other feedback that could inform treatment during and after your study participation.
You will have access to psychiatric care from a bipolar disorder treatment expert
You may gain a greater knowledge of bipolar disorder and its management, including strategies and information to help reduce your risk for mood episodes
Participation may improve your well-being, coping, or lifestyle
You will receive keto meals for 16 weeks without costs

What are the possible risks and/or discomforts?

While transitioning to a keto diet, you may experience some discomforts such as upset stomach, non-keto food cravings, headache, cramps, light-headedness, or decreased energy
Dietary side effects could also include some constipation, mood swings, or appetite changes
Participation also requires 2 blood draws with 12-hour fasting beforehand. Possible side effects of blood draws are some hunger and thirst from fasting; anxiety; minor discomfort; possible bruising, redness, swelling or bleeding at the needle entry site; lightheadedness; and rarely, an infection at the site. We also ask that participants complete daily finger-prick tests during the 16-week diet, which may cause discomfort.

Will I be paid for my participation in this study?

You will be financially compensated for completing research assessments. You may earn up to $380 total if you remain in the study protocol and complete all elements including the 16-week diet and final check-in assessments. If you stop the study, you will be paid for research tasks that you completed up to that point. You will be compensated for various study components listed below:

Eligibility assessment, including labs
Pre-diet research assessment
Monthly research assessments during the diet (3 total)
Completing at least 4 finger-prick tests for ketone/blood sugar each week
Post-diet research assessment, including labs

Please contact us for more information about study compensation.

Are there any costs for taking part in this study?

The study will pay for research-related keto meals/snacks, supplements required because of keto therapy, study-specific testing or sessions (dietitian sessions, psychologist education and coaching sessions, assessments, blood and urine tests, neuropsychological testing, and any psychiatry visits that are not part of standard clinical care), and any other services that are provided only because you are participating in the study.

However, you or your health plan may be responsible to pay for all the types of items listed below:

Costs (or if you are using insurance, deductibles or co-pays) for psychiatric medications, psychiatrist sessions, and non-study health tests that are provided to you as part of your standard health care.
Psychotherapy sessions not given by our team
Health care given that is part of your regular health maintenance (for example, visits with a general practitioner or blood tests that are part of any physical exam)