2-HOBA: Multiple Dosing Study in Healthy Humans

Healthy Volunteers Clinical Trial

— 2-HOBA  

Official title:

2-Hydroxybenzylamine: Multiple Dosing Study in Healthy Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03555682
• Other study ID #: MTI2018-CS01
• Secondary ID: R44AG055184
• Status: Completed
• Phase: N/A
• Start date: May 23, 2018
• Est. completion date: May 10, 2019

Study information

• Verified date: August 2019
• Source: Metabolic Technologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 10, 2019
• Est. primary completion date: May 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Dietary Supplement:
• 2-HOBA
2-HOBA is a compound found in buckwheat and is given as 2-HOBA acetate
• Placebo
Placebo Comparator

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Metabolic Technologies Inc.	National Institute on Aging (NIA), Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Blood Pressure	Blood pressure will be measured as an indicator of efficacy against oxidative stress (mm Hg).	15 Days
Secondary	Maximum Plasma Concentration (Cmax)	Cmax will be calculated from multiple timed plasma measurements (ng/ml).	Day 1 and Day 15
Secondary	Area Under the Curve (AUC)	AUC will be calculated from multiple timed plasma measurements (hr*ng/ml).	Day 1 and Day 15