Keto Diet Study for Teens and Young Adults with Bipolar Disorder
We are looking for young people with bipolar disorder to join a study. The study will test if a special 16-week keto diet, along with regular mental health care, is safe and helpful. We want to see if it can improve mood and health. We are especially looking for young people who have been feeling very sad or depressed lately.
Why this Research Matters
This research will help us learn whether combining a 16-week ketogenic diet (low carbohydrate, moderate protein, high fat) with regular mental health care is helpful for improving health of youth with bipolar disorder (such as in depression, executive functioning, metabolic variables, and inflammatory markers).
What to Expect
If you join the study, you will get a full health check and a mental health evaluation from experts in bipolar disorder. You’ll first have a screening visit to see if you qualify. If you’re eligible, you’ll begin the 16-week keto diet. During the study, you’ll do fingerstick tests at home to check your ketone levels, meet with a psychiatrist once a month, and come to the clinic for monthly visits. At these visits, you’ll fill out forms and get a physical check-up. At the end of the study, you’ll have a final clinic visit where you’ll do more forms, another check-up, and give a blood sample. The study lasts about 4 to 5 months (around 22 weeks). If you’re approved for the diet, you’ll get fresh keto meals delivered for 16 weeks or money to buy your own keto food. You’ll meet weekly with a dietitian and get support from a psychologist and a nurse who knows a lot about the keto diet. If you’re under 18, a parent must agree for you to join. Some visits will be online (telehealth), and some will be in person at our CU Medicine clinics. You’ll have to do some blood tests and daily fingerstick tests. Up to 20 people from your area will take part in the study at the University of Colorado. Across the country, up to 80 people will join the study at four university medical centers. You will be paid for your time doing interviews and tests. If you complete the full study, including the 16-week diet and final check-in, you can earn up to $380. This includes payments for the first and last assessments, monthly interviews, and weekly ketone testing. If you leave the study early or are taken out of the study, you will still be paid for the parts you completed. All payments will be made through digital gift cards.
Study Duration
The study lasts 4-5 months and involves 4 phases: Phase 1: Eligibility Check. During Phase 1, we will be checking to see if the diet is safe for you by asking you to provide a blood and urine sample, meet with a dietitian and psychiatrist and answer questions about your health and mood. Phase 2: Diet Ramp Up Period During Phase 2, you will meet with a dietitian and our study team to learn more about the keto diet, explore reasons for trying the diet, and help you feel confident starting the diet. You'll receive support from our team to gradually incorporate keto meals. We will ask you to complete one research visit where we will ask questions about your mood and health. Phase 3: Keto Diet for 16 weeks During Phase 3, you will begin the keto diet with support from our team. You will start to 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. Phase 4: Post Diet Research Visits During Phase 4, 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.
Who can Participate
You may be able to join the study if you are between 14 and 21 years old and speak English. If you’re under 18, your parent or guardian must also speak English and agree to take part. You need to have bipolar disorder and recent mood struggles, like feeling depressed. You must be healthy enough for outpatient care and not have medical issues that could make the keto diet unsafe, like pregnancy, diabetes, or kidney problems.
Additional criteria will be checked by a doctor or study staff at your first visit.
Study ID
Protocol Number: 24-2497
Compensation Information
Meet the Team
Principal Investigator