Could a High-Fat diet tame bipolar mood swings in teens?
NCT ID NCT06920940
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a 16-week ketogenic diet (low carbs, high fat, medium protein) can help teens aged 12–21 with bipolar disorder. Eighty participants will receive the diet plus standard medication, with coaching from dietitians and monthly checkups. Researchers will track mood, metabolism, and how well teens stick with the diet.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ketogenic diet
- What this could lead to
- If it works, this could point toward a dietary approach to help manage bipolar symptoms in teens alongside standard medication.
- What could go wrong
- This is an early, small pilot study (80 teens) testing feasibility, not a proven treatment. The strict diet may be hard to follow, and results may not apply to all teens with bipolar disorder.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2025
- Expected to finish
-
Mar 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
12 to 21 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Youth must be ages 12 to 21 years old and speak English * Youth must be appropriate for outpatient treatment (i.e., not a danger to self or others; not acutely psychotic, suicidal or manic; not in need of partial or full hospitalization) * Youth must have a current BSD (bipolar I, II per DSM-5 criteria (Association, 2013) or other specified BSD by the University of Pittsburgh diagnostic criteria (Birmaher et al., 2006). The Pittsburgh other specified BSD criteria require recurrent and distinct 1-3 day periods (minimum 4 hours/day) in which there has been abnormally elevated, expansive, or irritable mood plus two (three, if irritable mood only) symptoms of mania that caused a change in functioning and totaled at least 4 days in the child's lifetime * Active symptoms: In the 2 weeks prior to study intake, participants must have had weekly depression Psychiatric Status Ratings (PSRs) of 3 (moderate) or higher (using the 1-6 depression severity scales from the Adolescent Longitudinal Follow-up Evaluation, or A-LIFE); or an interview-based Children's Depression Rating Scale, Revised (CDRS-R) score covering the prior 2 weeks of \> 20. Youth may also enter with mixed symptoms (e.g., simultaneous elevations of \> 3 on the PSR depression and hypomania scales, with Young Mania Rating Scale scores of 12 or higher), without meeting criteria for a full manic episode in the past month. * Participants must continue to meet the study's active symptom criteria when beginning the phase II keto "ramp-up" phase: a depression PSR rating of 3 or higher over the prior 2 weeks, and a CDRS-R score covering the prior 2 weeks of \> 20. * Youth/parents must be willing to participate in evaluation and medication management sessions with a study psychiatrist and the study dietitian for assessment of the diet and side effects. * Youth under 18 years old must have at least one English-speaking parent or other caregiving family member consenting to participate in the study and available for consultation if needed * Youth and (for minors) all parents/legal guardians with health care decision making rights must express willingness to have the youth be in the study and try the keto therapy, assuming that the youth is eligible. The team must ascertain that the participating minor's youth/caregiver is likely to make a strong effort to adhere to the study's protocol. Exclusion Criteria: The youth must not have any of the following needs or conditions for which the keto diet may be contraindicated: * pregnancy or breastfeeding * underweight (BMI below 18.5) or wasting syndrome (e.g., anorexia cachexia) * current or history of anorexia nervosa * current disordered eating (bulimia or binge eating disorder) * autism spectrum disorder diagnosis level 2 or greater (more than mild) * cardiac issues, including history of arrhythmia, or cardiovascular or cerebrovascular disease * type I and type II diabetes * history of seizures/epilepsy * history of stroke or cancer * unstable respiratory condition * severe gastroesophageal reflux (GERD; painful/impairing despite prescription medication) * substance use disorder (with an exception for mild cannabis or nicotine use disorders) * history of kidney stones/disease * diseases involving the pancreas, liver, gallbladder or thyroid, including Von Gierke's glycogen storage disease * Condition with high cholesterol of triglycerides will prompt physician review of eligibility (LDL\>190 or triglycerides\>500) * genetic metabolic disorders: either porphyria (impacting the body's ability to make hemoglobin) or fatty acid oxidation disorder (FAOD) * rare conditions of defective ketone production or breakdown (carnitine deficiency, carnitine palmitoyl-transferase deficiency, carnitine-acylcarnitine translocase deficiency, mitochondrial fatty acid β-oxidation disorders, Succinyl-CoA:3-ketoacid CoA transferase deficiency (SCOT), or pyruvate carboxylase deficiency) * youth must not be taking SGLT-2 inhibitors (e.g., canagliflozin), insulin, or sulfonylureas (to avoid hypogycemia), or Antihypertensive medication (e.g., lisinopril/ACE Angiotensin inhibitors ending in "pril", ARB Angiotensin II receptor blockers, spironolactone/Aldactone, Thiazide-type diuretics)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Adolescents are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
4 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
UCLA Semel Institute Max Gray Child and Adolescent Mood Disorders Program (CHAMP)
RECRUITINGLos Angeles, California, 90024, United States
-
University of Cincinnati College of Medicine
RECRUITINGCincinnati, Ohio, 45267, United States
-
University of Colorado Denver, Anschutz Medical Campus
NOT_YET_RECRUITINGAurora, Colorado, 80045, United States
-
University of Pittsburgh School of Medicine
NOT_YET_RECRUITINGPittsburgh, Pennsylvania, 15213, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A handful of peanuts a day: could it sharpen teen brains?
- Can a nasal insulin spray rev up brain energy and sharpen thinking in psychosis?
- Blood test could predict success of online therapy for depression?
- Could immune cells hold clues to bipolar disorder?
- A surgical showdown for teen shinbone fractures: which fix heals faster?
- Could 30 minutes of exercise boost kids' brain chemistry?