NCT03556319

2-HOBA: Multiple Dosing Study in Older Adults

2-Hydroxybenzylamine: Multiple Dosing Study in Older Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Metabolic Technologies Inc. · Industry
• Sex: All
• Age: 55 Years – 79 Years
• Healthy volunteers: Accepted

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.

Detailed description

Consenting volunteers between 55 and 79 years old with metabolic syndrome, including males, and post-menopausal females 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.

Conditions

• Older Adults

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	2-HOBA	2-HOBA is a compound found in buckwheat and is given as 2-HOBA acetate
DIETARY_SUPPLEMENT	Placebo	Placebo Comparator

Timeline

• Start date: 2018-05-23
• Primary completion: 2021-07-31
• Completion: 2021-07-31
• First posted: 2018-06-14
• Last updated: 2021-12-14

Locations

1 site across 1 country: United States