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The purpose of the KDRAFT study is to assess the feasibility and preliminary cognitive efficacy of a ketogenic diet therapy in patients with Alzheimer's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketogenic Diet Arm | Experimental | All participants will be assigned to the 3-month ketogenic diet intervention. Study partners will be instructed to assist participants in adherence to a 1:1 ketogenic diet (approximately 70% fat, <10% carbohydrate, and 20% protein). Participants will be provided medium chain triglyceride oil with a target intake of 1-2 tablespoons per day and micronutrient supplements consisting of multivitamin, vitamin D, calcium, and phosphorus. After the 3-month ketogenic diet, participants will complete a 1-month washout period in which they halt adherence to the ketogenic diet and resume their normal diet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketogenic Diet | Behavioral | All participants will be assigned to the 3-month 1:1 ketogenic diet intervention (approximately 70% fat, <10% carbohydrate, and 20% protein). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of days positive for urinary ketone production | Participants will measure and report daily urinary ketone status using Ketostix (Bayer, Germany). | Daily for 90 days (the length of the diet intervention) |
| Change in blood ketone levels induced by ketogenic diet | Serum beta-hydroxybutyrate levels will be measured at five monthly study visits; baseline prior to diet initiation, three monthly collections during the ketogenic diet intervention, and after the 1-month washout return to a regular diet. | Change from baseline serum beta-hydroxybutyrate levels at month 1, 2, 3 (end of ketogenic diet), and 4 (after 1-month washout). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cognitive performance on the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) | Global cognitive performance will be assessed by a psychometrician using the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog). The ADAS-Cog is an Alzheimer's disease specific, multi-domain cognitive assessment scored from 0-70 points with higher scores indicating poorer cognitive performance. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30931426 | Derived | Taylor MK, Swerdlow RH, Burns JM, Sullivan DK. An Experimental Ketogenic Diet for Alzheimer Disease Was Nutritionally Dense and Rich in Vegetables and Avocado. Curr Dev Nutr. 2019 Feb 20;3(4):nzz003. doi: 10.1093/cdn/nzz003. eCollection 2019 Apr. |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D055423 | Diet, Ketogenic |
| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| Change from baseline global cognitive scores at month 3 (end of ketogenic diet) and change from month 3 global cognitive scores at month 4 (end of 1-month washout). |
| Change in cognitive performance on the Mini-Mental State Exam (MMSE) | Global cognitive performance will be assessed by a psychometrician using the Mini-Mental State Exam (MMSE). The MMSE is a brief cognitive questionnaire with a maximum score of 30 points where higher scores indicate better cognitive performance. | Change from baseline global cognitive scores at month 3 (end of ketogenic diet) and change from month 3 global cognitive scores at month 4 (end of 1-month washout). |
| Dietary intake characterization prior to and after ketogenic diet initiation | Changes in food and nutrient intake will be assessed by monthly 3-day food records completed by participant study partners. | Dietary intake will be collected at Baseline, Month 1, Month 2, Month 3 |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |