Brain Penetrance of 2-HOBA in Humans

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-23

Study Completion Date

2019-02-08

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy Adults

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

The dietary supplement will be delivered to the Clinical Research Center by the Investigational Pharmacy at Vanderbilt University Medical Center.

Study Groups

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2-HOBA

2-Hydroxybenzylamine acetate: 550mg dose

Group Type EXPERIMENTAL

2-HOBA

Intervention Type DIETARY_SUPPLEMENT

2-HOBA is a compound found in buckwheat and is given as 2-HOBA acetate

Interventions

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2-HOBA

2-HOBA is a compound found in buckwheat and is given as 2-HOBA acetate

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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2-Hydroxybenzylamine

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes