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| ID | Type | Description | Link |
|---|---|---|---|
| 24446 | Other Grant/Funding Number | UPenn ITMAT | |
| R21AA031088-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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The research study is being conducted in health controls to better understand the effects of ketosis on brain functioning after 3 different, randomly assigned, 3-day dietary interventions and the acute effects of alcohol after consuming about 4-5 alcohol beverages. The labs visits will use magnetic resonance imaging (MRI) scans to study the brain, measuring levels of nicotinamide adenine dinucleotide (NAD), lactate, neurotransmitters glutamate, and Gamma-aminobutyric acid (GABA).
The research study is being conducted to better understand the effects of ketosis on brain functioning and the acute effects of alcohol. Healthy participants will undergo three randomly assigned dietary interventions, each lasting three days, followed by a study lab visit day on day 4. The three interventions are: (1) Eat a ketogenic diet for 3 days, (2) eat a control diet for 3 days with a ketone supplement drink, and (3) eat a control diet for 3 days. The dietary interventions will be spaced 1 week apart. The ketone supplement drink "bis-octanoyl (R)-1,3-butanediol" (Kenetik: Ketone Drink, VitaNav Inc., Washington D.C.) 12.5g of ketones, TID PO (by mouth).) is a dietary supplement that has been extensively studied in humans and is designated by the FDA as Generally Recognized as Safe (GRAS). Its use in this study is experimental. On the day of the 3 labs visits days, magnetic resonance imaging (MRI) will be used to study the brain. Specifically, levels of nicotinamide adenine dinucleotide (NAD) (a coenzyme that is important for energy metabolism), lactate (a metabolite produced during energy metabolism), and neurotransmitters glutamate and GABA. Following the scans, participants will be provided a dose of alcohol that will elevate participants breath alcohol levels to approximately 0.08% to measure the acute effects of alcohol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketogenic diet | Experimental | Eat a ketogenic diet for 3 days |
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| Control Diet | Placebo Comparator | Eat a control diet for 3 days |
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| Ketone supplement | Experimental | Eat a control diet for 3 days with a ketone supplement drink |
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| Alcohol Intervention | Experimental | Alcohol lab, participants will receive ethanol drinks that are dose-adjusted for body weight and sex differences in pharmacokinetics and calculated to obtain a final breath alcohol concentration of 0.08% |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketone Supplement | Dietary Supplement | Ketone supplement 3x day with control diet for 3 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in breath alcohol concentration | Breath alcohol concentration measured in mg/L of air. The range is .000 to .400 g/L. Change in breath alcohol concentration, pre to post alcohol consumption after 3 day diet intervention during lab day. | 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in motor agility tasks | Motor agility will be assessed with the grooved pegboard task, in which participants will place pegs onto a metal surface containing 25 keyhole-shaped holes that differ in orientation. Measured in seconds, range 0 to 5 minutes. Change in motor agility tasks pre to post alcohol consumption after 3 day diet intervention. | 3 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Corinde Wiers, Ph.D. | University of Pennsylvania | Principal Investigator |
| Henry Kranzler, MD | University of Pennsylvania | Study Director |
| Kyle Kampman, MD | University of Pennsylvania | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania Center for Studies of Addiction | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D007662 | Ketosis |
| D000435 | Alcoholic Intoxication |
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D055423 | Diet, Ketogenic |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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Three-way, open-labeled, crossover trial in which participants will undergo three alcohol tolerance tests, each following a 3-days dietary intervention: (1) control diet (~ 50% kcal carbohydrates), (2) ketogenic diet (~5-10% kcal carbohydrates), and (3) control diet with 3x daily administration of 10 g Ketone Supplement (KS) drink (30 g/day, Kenetik: ketone Drink, VitaNav Inc., Washington D.C.).
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| Control Diet | Other | Control Diet breakfast, lunch, and dinner for 3 days. |
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| Ketogenic diet | Other | Ketogenic Diet breakfast, lunch, and dinner for 3 days. |
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| Ethanol | Drug | After 3 days of diet intervention, participants will receive alcohol drinks that dose-adjusts for body weight and sex differences in pharmacokinetics and calculated to obtain a final breath alcohol concentration of 0.08% |
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| Change in cognitive performance tasks | Cognitive performance will be measured with a cued go/no-go task, in which participants will press a computer keyboard key in response to a "go" target and suppress the action in response to a "no-go" target. Measured in % correct responses 0-100. Pre to post alcohol consumption after 3 day diet intervention. | 3 hours |
| D019973 |
| Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |