Impact of a Ketogenic Diet on Metabolic and Psychiatric Health in Patients With Bipolar or Schizo… (NCT03935854) | Clinical Trial Compass
CompletedNot Applicable
Impact of a Ketogenic Diet on Metabolic and Psychiatric Health in Patients With Bipolar or Schizophrenia Illness
United States23 participantsStarted 2019-02-13
Plain-language summary
To initiate a low-carbohydrate, high-fat (LCHF) or ketogenic dietary (KD) intervention among a cohort of outpatients with either schizophrenia or bipolar illness who also have metabolic abnormalities, overweight/obesity, and/or are currently taking psychotropic medications experiencing metabolic side effects.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 18-75 years old
. Meet DSM V criteria for schizophrenia or bipolar disorder, any subtype, for \> 1 year and clinically stable (with no hospitalization for past 3 months)
. Currently taking psychotropic medication and gained at least 5% weight since starting medication or have a BMI greater than or equal to 26 kg/m2 or presence of at least one metabolic abnormality (hypertriglyceridemia, insulin resistance, dyslipidemia, impaired glucose tolerance)
. Willing to consent to all study procedures and attend follow-up appointments and motivated to follow the dietary program.
. Sufficient control over their food intake to adhere to study diets.
. Willingness to regularly monitor blood pressure, glucose, dietary intake, and body weight over the 4-month trial
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in heart rate from baseline
Timeframe: Baseline, 16 weeks
2
Change in blood pressure from baseline
Timeframe: Baseline, 16 weeks
3
Change in weight from baseline
Timeframe: Baseline, 16 weeks
4
Change in waist circumference from baseline
Timeframe: Baseline, 16 weeks
5
Change in visceral fat mass from baseline
Timeframe: Baseline, 16 weeks
6
Change in body fat mass from baseline
Timeframe: Baseline, 16 weeks
7
Percent Change in Hemoglobin A1c from baseline
Timeframe: Baseline, 16 weeks
8
Change in insulin resistance measure (HOMA-IR) from baseline