2-HOBA: Multiple Dosing Study in Healthy Humans

Metabolic Technologies

Status: Completed

Conditions: Healthy Volunteers

Treatments: Dietary Supplement: 2-HOBA; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT03555682

R44AG055184 (U.S. NIH Grant/Contract)

MTI2018-CS01

Details and patient eligibility

About

The purpose of this study is to test how well people tolerate a new dietary ingredient called 2-HOBA and how it is metabolized in the body. 2-HOBA is a compound that occurs naturally in buckwheat seeds. This dietary ingredient has been used in animal studies, and single doses have been tolerated well when given to a small group of healthy people. In this study we will test how well people tolerate taking 2-HOBA over 2 weeks and how it is metabolized by the body.

Full description

Consenting healthy volunteers between 18 and 59 years old with no morbidity, including males, and females who are not pregnant will be recruited for the study. Eighteen volunteers will be studied with a reasonable sampling of ethnicities from the Nashville area, and an effort will be made to recruit equal numbers of males and females. The study will be conducted by the Vanderbilt Clinical Research Center (CRC).

Based upon single dose pharmacokinetics, two multiple dose regimens will be studied to determine the safety, accumulation kinetics, and pharmacodynamic effects of multiple daily doses administered over 2 weeks. A complete health history and physical examination will be conducted by a physician. An EKG, baseline blood and urine sample, and vital signs will be taken prior to supplement administration. A physician will oversee all clinical aspects of the study and will be responsible for all trial-related medical decisions. Additionally, DNA will be collected from the blood drawn and used to determine if there are any genetic differences in metabolism of 2-HOBA. Volunteers will be given 3 daily doses of either placebo or one of two levels of 2-HOBA to determine the safety, accumulation kinetics, and pharmacodynamic effects of the multiple dose administration over a 2 week period.

Enrollment: 18 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy individuals between 18 and 59 years old;
• Men and women who are not pregnant at the time of study; and
• Not taking any medication 2 weeks prior to or during the study.

Exclusion criteria

• Inability to give informed consent;
• Diseases that could manifest symptoms or signs that would confound interpretation of the relationship between 2-HOBA action and potential adverse effects;
• Diseases that could manifest morbidity;
• Known cardiac disease, kidney disease, or hepatic dysfunction;
• Need to discontinue any drug that is administered as standard of care treatment; and
• Unwillingness or inability to use approved birth-control methods.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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18 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Placebo

2-HOBA Low Dose

Experimental group

Description:

2-Hydroxybenzylamine acetate: 500mg dose

Treatment:

Dietary Supplement: 2-HOBA

2-HOBA High Dose

Experimental group

Description:

2-Hydroxybenzylamine acetate: 750mg dose

Treatment:

Dietary Supplement: 2-HOBA