2-HOBA: Multiple Dosing Study in Healthy Humans (2-HOBA)

2-Hydroxybenzylamine: Multiple Dosing Study in Healthy Humans

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: 2-HOBA

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Placebo Comparator
Experimental: 2-HOBA Low Dose; 2-Hydroxybenzylamine acetate: 500mg dose	Dietary supplement: 2-HOBA; 2-HOBA is a compound found in buckwheat and is given as 2-HOBA acetate; Other Names: 2-Hydroxybenzylamine
Experimental: 2-HOBA High Dose; 2-Hydroxybenzylamine acetate: 750mg dose	Dietary supplement: 2-HOBA; 2-HOBA is a compound found in buckwheat and is given as 2-HOBA acetate; Other Names: 2-Hydroxybenzylamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multiple Dose Tolerability	Tolerability will be assessed through adverse event reporting compared with the placebo group (Comparison of number of AE in treated group to number of AE in placebo group).	15 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of oxidative protein adducts in platelets	Oxidative protein adducts will be measured in blood platelets as an indication of efficacy (ng adducted protein/mg protein).	15 Days
Blood Pressure	Blood pressure will be measured as an indicator of efficacy against oxidative stress (mm Hg).	15 Days
Maximum Plasma Concentration (Cmax)	Cmax will be calculated from multiple timed plasma measurements (ng/ml).	Day 1 and Day 15
Area Under the Curve (AUC)	AUC will be calculated from multiple timed plasma measurements (hr*ng/ml).	Day 1 and Day 15

Collaborators and Investigators

• Sponsor: Metabolic Technologies Inc.
• Collaborators: National Institute on Aging (NIA); Vanderbilt University
• Investigators: Principal Investigator: John A Rathmacher, PhD, Metabolic Technologies Inc.

Publications and helpful links

General Publications

• Pitchford LM, Driver PM, Fuller JC Jr, Akers WS, Abumrad NN, Amarnath V, Milne GL, Chen SC, Ye F, Roberts LJ 2nd, Shoemaker MB, Oates JA, Rathmacher JA, Boutaud O. Safety, tolerability, and pharmacokinetics of repeated oral doses of 2-hydroxybenzylamine acetate in healthy volunteers: a double-blind, randomized, placebo-controlled clinical trial. BMC Pharmacol Toxicol. 2020 Jan 6;21(1):3. doi: 10.1186/s40360-020-0382-y.

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2018
• Primary Completion (Actual): May 10, 2019
• Study Completion (Actual): May 10, 2019

Study Registration Dates

• First Submitted: May 29, 2018
• First Submitted That Met QC Criteria: June 12, 2018
• First Posted (Actual): June 13, 2018

Study Record Updates

• Last Update Posted (Actual): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Multiple Dosage
• Other Study ID Numbers: MTI2018-CS01; R44AG055184 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No