Health TrialsbyHealthPanel

Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder

ConditionsBipolar I DisorderPsychosisSchizoaffective Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorMclean Hospital

About this trial

This is a randomized, controlled clinical trial to assess the effects of the ketogenic diet in combination with treatment as usual on brain energy metabolism and psychiatric symptoms in individuals with first episode bipolar disorder and schizoaffective disorder.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Between the ages of 18 and 45.

Ability to adhere to study diets.

Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnosis of bipolar I disorder or schizoaffective disorder with onset of illness in the last 7 years.

Must have a stable psychiatric disorder with no change in psychiatric medications within the past 2 weeks of screening

Disqualifiers

Unable to sign informed consent

Contraindication to magnetic resonance (MR) scan (including claustrophobia)

Unstable medical illness (including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease)

Current DSM-5 substance use disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ketogenic diet

    Other intervention

    The ketogenic diet (KD) is a normo-caloric diet composed of high-fat, low carbohydrate, and adequate protein intake. The KD will consist of 3 meals a day plus snacks, targeting 75-80% fat, 13-18% protein, 7% carbohydrates.

  • Dietary Guidelines for Americans

    Other intervention

    Dietary Guidelines for Americans diet is a normo-caloric diet consisting of 3 meals a day plus snacks, emphasizing nutrient dense foods to meet food group needs (85% of calories), and limits foods and beverages higher in added sugars and saturated fat (15% of calories).

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Ketogenic diet armActive comparator 1 intervention
Group B: Dietary Guidelines for Americans armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in brain redox nicotinamide adenine dinucleotide metabolites ratio (NAD+/NADH)

Change from baseline to week 12 in NAD+/NADH as measured by in vivo phosphorus magnetic resonance spectroscopy (31P-MRS).

Time frame
12 weeks
2

Change in brain creatine kinase forward reaction rate (kf)

Change from baseline to week 12 in creatine kinase forward reaction rate (kf) as measured by 31P magnetization transfer (MT) MRS.

Time frame
12 weeks
3

Change in insulin resistance

Change from baseline to week 12 of insulin resistance measured using the homeostatic model assessment of insulin resistance (HOMA-IR) using fasting blood glucose and insulin levels.

Time frame
12 weeks
4

Change in psychotic symptoms

Change from baseline to week 12 in Positive and Negative Syndrome Scale (PANSS) total score. Scores range from 30-210; a higher score indicates a higher level of psychotic symptoms.

Time frame
12 weeks

Secondary outcomes

1

Change in body weight

Change from baseline to week 12 in participant body weight in kilograms, as measured using a standing scale.

Time frame
12 weeks
2

Change in glycated hemoglobin (Hemoglobin A1c) level

Change from baseline to week 12 in fasting Hemoglobin A1c level.

Time frame
12 weeks
3

Change in triglyceride levels

Change from baseline to week 12 in fasting triglyceride levels.

Time frame
12 weeks
4

Change in low-density lipoprotein (LDL) levels

Change from baseline to week 12 in fasting LDL levels.

Time frame
12 weeks

Other outcomes

1

Change in World Health Organization Disability Assessment Schedule (WHODAS) score

Change from baseline to week 12 in World Health Organization Disability Assessment Schedule (WHODAS) scale. Scores range from 0-144. A higher score indicates greater dysfunction and disability in major life domains.

Time frame
12 weeks
2

Change in World Health Organization Quality of Life (WHOQOL) score

Change from baseline to week 12 in World Health Organization Quality of Life (WHOQOL) scale. Scores range from 1-130. A lower score indicates lower perceived quality of life.

Time frame
12 weeks
3

Change in Extrapyramidal Symptom Rating Scale (ESRS) total score

Change from baseline to week 12 in Extrapyramidal Symptom Rating Scale (ESRS) total score. Scores range from 0-102; a higher score indicates more severe symptoms.

Time frame
12 weeks
4

Change in Pittsburgh Sleep Quality Index (PSQI) total score

Change from baseline to week 12 in Pittsburgh Sleep Quality Index (PSQI) total score. Scores range from 0-21; a higher score indicates worse sleep quality.

Time frame
12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mclean Hospital

Lead sponsor

Baszucki Family Foundation

Collaborator

Source ClinicalTrials.gov
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