2-HOBA: Multiple Dosing Study in Healthy Humans

NCT ID: NCT03555682

Last Updated: 2019-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-23
• Study Completion Date: 2019-05-10

Brief 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 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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo Comparator

2-HOBA Low Dose

2-Hydroxybenzylamine acetate: 500mg 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

2-HOBA High Dose

2-Hydroxybenzylamine acetate: 750mg 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

2-HOBA

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo Comparator

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

2-Hydroxybenzylamine

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Metabolic Technologies Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

John Rathmacher, PhD

Director of Clinical Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John A Rathmacher, PhD

Role: PRINCIPAL_INVESTIGATOR

Metabolic Technologies Inc.

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31907026 (View on PubMed)

Other Identifiers

R44AG055184

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MTI2018-CS01

Identifier Type: -

Identifier Source: org_study_id