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This study will investigate the effects of ketone supplementation on eating behavior including drive to binge eat or restrict, mood and anxiety in individuals with anorexia or bulimia nervosa. In addition, the investigators will contrast the effects of active ketone supplementation versus placebo on electroencephalogram (EEG) measurement. All subjects enrolled in the study will undergo EEG on two consecutive days at the beginning of the study, after active ketone supplementation or placebo drink, matched in taste to the ketone drink. Days will be randomized. Thereafter, all subjects will take the ketone supplementation drink for two weeks, twice daily.
The goals of the study are:
1) to test the effect of BHB as a nutritional supplement for AN and BN and 2) to test the ingestion of BHB on brain function.
Subjects will complete a battery of self-assessments and a diagnostic assessment in order to determine eligibility and for characterization of behavior to be used in later analyses. After eligibility is confirmed, subjects will complete 2 EEG scans on separate days after ingestion of Ketone supplement drink or placebo and will complete a taste reward task during the EEG scan. Subjects will then complete 2 weeks of daily ketone supplementation and self-assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketone Supplementation | Experimental | Subjects will ingest 2 daily doses of Kenetik ketone drink supplementation for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kenetik Ketone Drink | Dietary Supplement | BHB supplementation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Eating Disorders Inventory 3 Drive for Thinness Subscale | The Eating Disorders Inventory 3 is a self report assessment that measures core eating disorder symptoms. Subjects will complete this measure at the beginning and end of the study and the investigator will measure the change in scores. The Drive for Thinness Subscale has a range of 0 to 28 where higher scores mean worse outcome. | Change from baseline to study completion, up to 2 weeks |
| Eating Disorders Inventory 3 (EDI-3) Body Dissatisfaction Subscale | The Eating Disorders Inventory 3 is a self report assessment that measures core eating disorder symptoms. Subjects will complete this measure at the beginning and end of the study and the investigator will measure the change in scores. The Drive for Thinness Subscale has a range of 0 to 40 where higher scores mean worse outcome. | Change from baseline to study completion, up to 2 weeks |
| Weight Change | Body Mass Index over time as a measure of food intake from the start to end of the study | Change in body mass index from baseline to study completion, up to 2 weeks] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guido Frank, MD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | San Diego | California | 92121 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9797933 | Background | Mills IH, Park GR, Manara AR, Merriman RJ. Treatment of compulsive behaviour in eating disorders with intermittent ketamine infusions. QJM. 1998 Jul;91(7):493-503. doi: 10.1093/qjmed/91.7.493. | |
| 34190963 | Background | Frank GKW, Shott ME, Stoddard J, Swindle S, Pryor TL. Association of Brain Reward Response With Body Mass Index and Ventral Striatal-Hypothalamic Circuitry Among Young Women With Eating Disorders. JAMA Psychiatry. 2021 Oct 1;78(10):1123-1133. doi: 10.1001/jamapsychiatry.2021.1580. |
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| ID | Term |
|---|---|
| D000856 | Anorexia Nervosa |
| D052018 | Bulimia Nervosa |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
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All subjects will complete 2-weeks daily ketone supplementation
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| 19559687 | Background | Cheng B, Yang X, An L, Gao B, Liu X, Liu S. Ketogenic diet protects dopaminergic neurons against 6-OHDA neurotoxicity via up-regulating glutathione in a rat model of Parkinson's disease. Brain Res. 2009 Aug 25;1286:25-31. doi: 10.1016/j.brainres.2009.06.060. Epub 2009 Jun 25. |
| 28972576 | Background | Kokkinou M, Ashok AH, Howes OD. The effects of ketamine on dopaminergic function: meta-analysis and review of the implications for neuropsychiatric disorders. Mol Psychiatry. 2018 Jan;23(1):59-69. doi: 10.1038/mp.2017.190. Epub 2017 Oct 3. |
| 30075165 | Background | 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. |