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The goal of this clinical trial is to learn if a state of ketosis and physical activity will increase serum BDNF concentrations and improve cognition, specifically in individuals who possess the Met allele from the BDNF Val66Met SNP. The main questions it aims to answer are:
Researchers will compare a ketosis supplement to a placebo (a look-alike substance that contains no drug) to see if the ketosis supplement and physical activity increases serum BDNF and improves cognition.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketosis Trial | Experimental | Participants will be given a sugar-free electrolyte mixture with d-beta-hydroxybutrate to drink in a 1:1 ratio calculated to 0.1816g/lb based on body weight before the treadmill test. |
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| Placebo Trial | Placebo Comparator | Participants consume a placebo consisting of a pure sugar-free electrolyte drink before treadmill test. The grams of placebo will be calculated 0.1816g/lb based on body weight. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| d-beta-hydroxybutrate | Drug | During the ketosis trial, participants will be given d-beta-hydroxybutrate mixed with sugar-free gatorade in a 1:1 ratio. This is to ensure the participant's electrolytes are high and to mask the bitter taste of d-beta-hydroxybutrate. The dosage per participant will be calculated 0.1816g/lb based on body weight to ensure participants remain in a state of ketosis for a minimum of 2 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum BDNF | Whole blood will be taken from participants before and after the treadmill test for both placebo and ketosis trial days. Serum will be extracted and an ELIZA will be run to assess serum BDNF concentrations. | baseline, pre-intervention/procedure/surgery, and immediately after the intervention/procedure/surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Cognition | RBANS, Repeatable Battery for the Assessment of Neuropsychological Status, will be administered to participants before and after each respective trial day, both placebo and ketosis trials. | baseline, pre-intervention/procedure/surgery, and immediately after the intervention/procedure/surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anamika Nanda | Contact | 4254639902 | 01 | anamikan@usc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90089 | United States |
At this time we do not intend to share IPD to protect their anonymity
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| Placebo | Drug | Participants will consume a placebo consisting of a pure electrolyte drink. |
|
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D007662 | Ketosis |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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