This is a 12-week open-label extension study for participants completing study NCT06221852.
In this 12-week single arm open label extension study of NCT06221852, the investigators aim to assess the longer term efficacy, safety and tolerability of the ketogenic diet in participants completing the randomized study phase of NCT06221852. Investigators will assess longer term effects on energy metabolism, insulin resistance and psychiatric symptoms.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
McLean Hospital
Belmont, Massachusetts, United States
Change in brain redox nicotinamide adenine dinucleotide metabolites ratio (NAD+/NADH)
Change from baseline to week 24 in NAD+/NADH as measured by in vivo phosphorus magnetic resonance spectroscopy (31P-MRS).
Time frame: 24 weeks
Change in brain creatine kinase forward reaction rate (kf)
Change from baseline to week 24 in creatine kinase forward reaction rate (kf) as measured by 31P magnetization transfer (MT) MRS.
Time frame: 24 weeks
Change in insulin resistance
Change from baseline to week 24 of insulin resistance measured using the homeostatic model assessment of insulin resistance (HOMA-IR) using fasting blood glucose and insulin levels.
Time frame: 24 weeks
Change in psychotic symptoms
Change from baseline to week 24 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: 24 weeks
Change in depressive symptoms
Change from baseline to week 24 in Hamilton Rating Scale for Depression (HAM-D) total score. Scores range from 0-52; a higher score indicates a higher level of depression.
Time frame: 24 weeks
Change in mania symptoms
Change from baseline to week 24 in Young Mania Rating Scale (YMRS) total score. Scores range from 0-60. A higher score indicates a more severe illness.
Time frame: 24 weeks
Change in Clinical Global Impression (CGI) Scale
Change from baseline to week 24 in Clinical Global Impression (CGI) Scale. Scores range from 1-7; a higher score indicates higher severity of illness.
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Time frame: 24 weeks
Change in body weight
Change from baseline to week 24 in participant body weight in kilograms, as measured using a standing scale.
Time frame: 24 weeks
Change in glycated hemoglobin (Hemoglobin A1c) level
Change from baseline to week 24 in fasting Hemoglobin A1c level.
Time frame: 24 weeks
Change in triglyceride levels
Change from baseline to week 24 in fasting triglyceride levels.
Time frame: 24 weeks
Change in low-density lipoprotein (LDL) levels
Change from baseline to week 24 in fasting LDL levels
Time frame: 24 weeks
Change in high-density lipoprotein (HDL) levels
Change from baseline to week 24 in fasting HDL levels
Time frame: 24 weeks
Change in high-sensitivity C-reactive protein (hs-CRP) levels
Change from baseline to week 24 in fasting hs-CRP levels.
Time frame: 24 weeks
Change in brain gamma-aminobutyric acid (GABA) concentration
Change from baseline to week 24 in GABA concentration measured by proton magnetic resonance spectroscopy.
Time frame: 24 weeks
Change in brain glutamate metabolite concentration
Change from baseline to week 24 in glutamate metabolite concentration measured by proton magnetic resonance spectroscopy.
Time frame: 24 weeks
Change in brain glutathione (GSH)
Change from baseline to week 24 in brain GSH measured by proton magnetic resonance spectroscopy.
Time frame: 24 weeks
Change in brain Phosphocreatine (PCr)
Changes from baseline to week 24 in PCr concentration as measured by in vivo 31P-MRS.
Time frame: 24 weeks
Change in brain pH
Change from baseline to week 24 in pH as measured by in vivo 31P MRS
Time frame: 24 weeks
Change in brain inorganic phosphate concentration
Change from baseline to week 24 in inorganic phosphate (Pi) concentration as measured by in vivo 31P MRS.
Time frame: 24 weeks
Change in adverse events
Change from baseline to week 24 in adverse events.
Time frame: 24 weeks
Change in anxiety symptoms
Change from baseline to week 24 from baseline to week 12 in Hamilton Anxiety Rating Scale (HAM-A) total score. Scores range from 0 - 56; a higher score indicates a higher level of anxiety.
Time frame: 24 weeks
Change in stress symptoms
Change from baseline to week 24 in Depression Anxiety Stress Scales (DASS-42) Stress Subscale score. Scores range from 0-42; a higher score indicates a higher level of stress.
Time frame: 24 weeks
Change in cognitive performance
Change from baseline to week 24 in Matrics Consensus Cognitive Battery (MCCB) Total Score. Scores range from 0.00% - 100.00%; a higher score indicates higher cognition.
Time frame: 24 weeks
Change in Global Functioning Scale (GFS) - Social and Role total score
Change from baseline to week 24 in Global Functioning Scale (GFS) - Social and Role total score. Scores range from 6-60; a lower score indicates worse social and role functioning.
Time frame: 24 weeks
Change in blood NAD/NADH+ ratio
Change from baseline to week 24 in blood NAD/NADH+ ratio.
Time frame: 24 weeks
Change in blood GSH/GSSH ratio
Change from baseline to week 24 in blood GSH/GSSH ratio.
Time frame: 24 weeks
Change in growth differentiation factor 15 (GDF15)
Change from baseline to week 24 in blood and saliva GDF15 levels.
Time frame: 24 weeks
Change in cell-free mitochondrial DNA (cf-mtDNA)
Change from baseline to week 24 in blood and saliva cf-mtDNA levels.
Time frame: 24 weeks