Healthy Adults
Conditions
Keywords
Multiple Dosage
Brief summary
The purpose of this study is to confirm that 2-HOBA crosses the blood brain barrier and to compare blood and cerebrospinal fluid levels of 2-HOBA after a single oral dose.
Detailed description
Consenting volunteers between 40 and 70 years old with no morbidity, including males, and females who are not pregnant will be recruited for the study. Three volunteers will be enrolled with a reasonable sampling of ethnicities from the Nashville area, and an effort will be made to recruit males and females. The study will be conducted by the Vanderbilt Clinical Research Center (CRC). Briefly, the three volunteers will be studied at a single dose level. Baseline assessments will be performed, and then each volunteer will be given a single oral dose (550 mg) of 2-HOBA. Ninety minutes after the dose, a lumbar puncture will be performed to obtain cerebrospinal fluid and a blood sample will be collected. 2-HOBA levels will be measured in cerebrospinal fluid and blood samples from this timepoint to assess the ability or orally ingested 2-HOBA to cross the blood brain barrier.
Interventions
DIETARY_SUPPLEMENT2-HOBA
2-HOBA is a compound found in buckwheat and is given as 2-HOBA acetate
Sponsors
Vanderbilt University
National Institute on Aging (NIA)
Metabolic Technologies Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
The dietary supplement will be delivered to the Clinical Research Center by the Investigational Pharmacy at Vanderbilt University Medical Center.
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy individuals between 40 and 70 years old; * Men and women who are not pregnant at the time of study; and * Not taking any medication 24 hours prior to and during the study.
Exclusion criteria
* Inability to give informed consent; * Current use of anticoagulant medications, such as warfarin (Coumadin), dabigatran (Pradaxa), or rivaroxaban (Xarelto), due to high risk of bleeding complications. Volunteers taking aspirin or clopidogrel (Plavix), will not be excluded, but will be asked to get clearance from their prescribing physician before stopping the drug 24 hours prior to the procedure; * Need to discontinue any drug that is administered as standard of care treatment; * Unwillingness or inability to use approved birth-control methods (pre-menopausal women); and * History of lumbar surgery, fibromyalgia, current lower back pain, or scoliosis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brain Penetrance | 90 minutes | Ratio of 2-HOBA concentration in the cerebrospinal fluid to plasma 2-HOBA concentration after oral administration (ng/mL) |
Countries
United States
Outcome results
None listed