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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05705063
Other study ID # 68493
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 30, 2023
Est. completion date December 30, 2024

Study information

Verified date January 2023
Source Stanford University
Contact Diane E Wakeham, PhD
Phone 650-736-5243
Email wakeham@stanford.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To initiate a low-carbohydrate, high-fat (LCHF) or ketogenic dietary (KD) intervention among a cohort of outpatients with bipolar illness who also have metabolic abnormalities, overweight/obesity, and/or are currently taking psychotropic medications experiencing metabolic side effects.


Description:

Adults with mental illness represent a high-risk, marginalized group in the current metabolic and obesity epidemic. Among US adults with severe mental illness, metabolic syndrome are highly prevalent conditions having severe consequences, with patients estimated to die on average 25 years earlier than the general population largely of premature cardiovascular disease. Many psychiatric medications, particularly neuroleptics and mood stabilizers, may, in addition, contribute to metabolic side effects and weight gain. Low-carbohydrate high-fat (LCHF) or ketogenic diets (KD) have been shown to reduce cardiovascular risk in those with insulin resistance. Recent findings support the idea that bipolar disorder may have roots of metabolic dysfunction: cerebral glucose hypometabolism, oxidative stress, as well as mitochondrial and neurotransmitter dysfunction which has downstream effects on synapse connections. A KD diet provides alternative fuel to the brain aside from glucose and is believed to contain beneficial neuroprotective effects, including stabilization of brain networks, reduction of inflammation and oxidative stress. The purpose of this study is to evaluate both the metabolic and psychiatric outcomes with a KD diet in this psychiatric population.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date December 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Male or female, 18 to 75 years of age. 2. Able to provide informed consent. 3. Meet DSM V criteria for diagnosis with Bipolar Disorder (BPD), any subtype, for > 1 year and clinically stable (with no hospitalization for past 3 months) 4. Participants may currently be on a stable and adequate dose of SSRI antidepressant therapy or other psychiatric medications. Concurrent hypnotic therapy (e.g., with zolpidem, zaleplon, melatonin, or trazodone) will be allowed if the therapy has been stable for at least 4 weeks prior to screening and if it is expected to remain stable. Participants may choose to not be on antidepressant therapy for the study duration, or to be switched from other classes to a medication from the SSRI class. 5. currently taking SSRI or 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) 6. In good general health, as ascertained by medical history. 7. If female, a status of non-childbearing potential or use of an acceptable form of birth control. The form of birth control will be documented at screening and baseline. 8. willing to consent to all study procedures and attend follow-up appointments and motivated to follow dietary program. 9. Sufficient control over their food intake to adhere to study diets. 10. willingness to regularly monitor blood pressure, glucose, dietary intake, and body weight over 6-week trial Exclusion Criteria: 1. Female of childbearing potential who is not willing to use one of the specified forms of birth control during the study. 2. Female that is pregnant or breastfeeding. 3. Female with a positive pregnancy test at participation. 4. comorbidity of developmental delay or Cognitive impairment (as noted by previous diagnoses-including dementia). 5. Current diagnosis of a Substance Use Disorder (Abuse or Dependence, as defined by DSM-IV-TR), with the exception of nicotine dependence, at screening or within six months prior to screening. 6. History of positive screening urine test for drugs of abuse at screening: cocaine, amphetamines, barbiturates, opiates. 7. Current (or chronic) use of opiates. 8. in a current severe mood or psychotic state when entering the study that would prohibit compliance with study visits or dietary program. 9. Considered at significant risk for suicide during the course of the study. 10. any one who has been hospitalized or taken clozapine at doses above 550mg over the past 3 months 11. Has a clinically significant abnormality on the screening examination that might affect safety, study participation, or confound interpretation of study results. 12. Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation. 13. Participation in any clinical trial with an investigational drug or device within the past month or concurrent to study participation. 14. inability to complete baseline measurements 15. severe renal or hepatic insufficiency 16. cardiovascular dysfunction, including diagnosis of: 1. Congestive heart failure 2. Angina 3. Arrhythmias 4. Cardiomyopathy 5. Valvular heart disease 6. History of cardiovascular disease or cardiac event. 17. any other medical condition that may make either diet dangerous as determined by the study medical team (e.g. anorexia nervosa)

Study Design


Intervention

Other:
LCHF Ketogenic Diet
Low Carbohydrate, Moderate Protein, High Fat Ketogenic Dietary Intervention 6 weeks

Locations

Country Name City State
United States Stanford University School of Medicine Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (8)

Brietzke E, Mansur RB, Subramaniapillai M, Balanza-Martinez V, Vinberg M, Gonzalez-Pinto A, Rosenblat JD, Ho R, McIntyre RS. Ketogenic diet as a metabolic therapy for mood disorders: Evidence and developments. Neurosci Biobehav Rev. 2018 Nov;94:11-16. doi: 10.1016/j.neubiorev.2018.07.020. Epub 2018 Jul 31. — View Citation

Carmen M, Safer DL, Saslow LR, Kalayjian T, Mason AE, Westman EC, Sethi Dalai S. Treating binge eating and food addiction symptoms with low-carbohydrate Ketogenic diets: a case series. J Eat Disord. 2020 Jan 29;8:2. doi: 10.1186/s40337-020-0278-7. eCollection 2020. — View Citation

Danan A, Westman EC, Saslow LR, Ede G. The Ketogenic Diet for Refractory Mental Illness: A Retrospective Analysis of 31 Inpatients. Front Psychiatry. 2022 Jul 6;13:951376. doi: 10.3389/fpsyt.2022.951376. eCollection 2022. — View Citation

Imdad K, Abualait T, Kanwal A, AlGhannam ZT, Bashir S, Farrukh A, Khattak SH, Albaradie R, Bashir S. The Metabolic Role of Ketogenic Diets in Treating Epilepsy. Nutrients. 2022 Nov 29;14(23):5074. doi: 10.3390/nu14235074. — View Citation

Norwitz NG, Sethi S, Palmer CM. Ketogenic diet as a metabolic treatment for mental illness. Curr Opin Endocrinol Diabetes Obes. 2020 Oct;27(5):269-274. doi: 10.1097/MED.0000000000000564. — View Citation

Sethi S, Ford JM. The Role of Ketogenic Metabolic Therapy on the Brain in Serious Mental Illness: A Review. J Psychiatr Brain Sci. 2022;7(5):e220009. doi: 10.20900/jpbs.20220009. Epub 2022 Oct 31. — View Citation

Sethi S, Sinha A, Gearhardt AN. Low carbohydrate ketogenic therapy as a metabolic treatment for binge eating and ultraprocessed food addiction. Curr Opin Endocrinol Diabetes Obes. 2020 Oct;27(5):275-282. doi: 10.1097/MED.0000000000000571. — View Citation

Unwin J, Delon C, Giaever H, Kennedy C, Painschab M, Sandin F, Poulsen CS, Wiss DA. Low carbohydrate and psychoeducational programs show promise for the treatment of ultra-processed food addiction. Front Psychiatry. 2022 Sep 28;13:1005523. doi: 10.3389/fpsyt.2022.1005523. eCollection 2022. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Weight from Baseline Weight recorded weekly during study Baseline, 6 weeks
Primary Change in Waist Circumference from Baseline Waist circumference recorded at each visit during study Baseline, 6 weeks
Primary Change in Heart Rate from Baseline Heart rate recorded at each visit during study Baseline, 6 weeks
Primary Change in Blood Pressure from Baseline Blood pressure recorded weekly during study Baseline, 6 weeks
Primary Change in Visceral Fat Mass from Baseline Kg visceral fat in body composition (SECA or Inbody) recorded 2-3 times during study Baseline, 6 weeks
Primary Change in Body Fat Mass from Baseline Kg body fat in body composition (SECA or Inbody) recorded 2-3 times during study Baseline, 6 weeks
Primary Change in Hemoglobin A1c from Baseline Blood measurement of Hemoglobin A1c recorded at baseline and study end Baseline, 6 weeks
Primary Change in Insulin Resistance Measure (HOMA-IR) from Baseline HOMA-IR calculated from blood measurements recorded at baseline and study end Baseline, 6 weeks
Primary Change in Inflammatory Marker (hs-CRP) from Baseline Blood measurement of hs-CRP recorded at baseline and study end Baseline, 6 weeks
Primary Change in Lipid Profile (TG) from Baseline Blood levels of Lipid Triglycerides (TG) recorded at baseline and study end Baseline, 6 weeks
Primary Change in Lipid Profile small LDL from Baseline Blood levels of small, low density lipoprotein cholesterol (LDL-C) recorded at baseline and study end Baseline, 6 weeks
Primary Change in Lipid Profile HDL from Baseline Blood levels of high density lipoprotein cholesterol (HDL-C) recorded at baseline and study end Baseline, 6 weeks
Secondary Change in Clinical Mood Monitoring from Baseline Change in Clinical Mood Monitoring Psychiatric Index from Baseline Baseline, 6 weeks
Secondary Change in Clinical Global Impression from Baseline Change in Clinical Global Impression (CGI) Psychiatric Index from Baseline; 1-7 scale. (1= not at all ill, 7= among the most extremely ill patients) Baseline, 6 weeks
Secondary Change Generalized Anxiety Disorder from Baseline Change in General Anxiety Disorder (GAD-7) scale from Baseline. 0-15+ scale. (0= no anxiety, 15+= severe anxiety) Baseline, 6 weeks
Secondary Change in Depression from Baseline Change in Depression on Patient Health Questionnaire (PHQ-9) scale from Baseline; Score range 0-27 (0= no depression, 27= severe depression) Baseline, 6 weeks
Secondary Change in Global Assessment of Functioning from Baseline Change in Global Assessment of Functioning (GAF) scale from baseline; 1-100 scale (1= persistent danger of hurting self or others, 100= superior functioning) Baseline, 6 weeks
Secondary Change in Quality of Life from Baseline Change in Manchester Quality of Life (MANSA) scale from baseline; Range 12-84 (each of 12 outcomes rated from 1= could not be worse to 7= could not be better; <4= dissatisfied with QoL, >4= satisfied with QoL) Baseline, 6 weeks
Secondary Change in Quality of Sleep from Baseline Change in Pittsburgh Sleep Quality Index (PSQI) from baseline; 0-21 scale (<5=good sleeper; 5+= meaningfully disturbed sleep or poor sleeper) Baseline, 6 weeks
Secondary Change in Eating Behavior from Baseline Change in Binge Eating Scale (BES) from Baseline; 0-46 scale (<17 minimal binge eating problems, >27 severe binge eating problems) Baseline, 6 weeks
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