Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06065657
Status:
RECRUITING
Last Update Posted:
2024-01-24
First Post:
2023-09-20
Brief Title:
Effect of Nutritional Ketosis on Alcohol Metabolism
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Effect of Nutritional Ketosis on Alcohol Metabolism
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KAM
Brief Summary:
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
Detailed Description:
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 Kenetik Vitanav inc Washington DC 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 008 to measure the acute effects of alcohol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 24446 | OTHER_GRANT | UPenn ITMAT | None |