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2-HOBA: Multiple Dosing Study in Older Adults

NCT ID: NCT03556319

Last Updated: 2021-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-23

Study Completion Date

2021-07-31

Brief Summary

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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

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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

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Older Adults

Keywords

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Multiple Dosage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned in a blinded fashion to 2-HOBA or placebo. A computer-generated randomization sequence with a block of size 3 will be used to assign participants at the ratio of 1:2 (placebo:2-HOBA) at each dose level of the treatment. All participants receiving the lower dose regimen will be completed before enrolling participants in the higher dose group.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
The dietary supplement will be delivered to the Clinical Research Center by the Investigational Pharmacy at Vanderbilt University Medical Center. Staff nurses and participants will be blinded to the capsule content.

Study Groups

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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

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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

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2-Hydroxybenzylamine

Eligibility Criteria

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Inclusion Criteria

* Individuals between 55 and 79 years old with metabolic syndrome
* Men and post-menopausal women.

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 manifest current morbidity;
* Known cardiac disease, kidney disease, hepatic dysfunction, or diagnosed coronary artery disease;
* Cancer with potential terminal outcome or under treatment at the time of study;
* Severe hypertension (defined by systolic blood pressure equal or higher than 170 mm Hg), cardiac pacemaker, or oral anticoagulant use at the time of the study; and
* Individuals with diabetes requiring insulin treatment.
Minimum Eligible Age

55 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vanderbilt University

OTHER

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Metabolic Technologies Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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John Rathmacher, PhD

Director of Clinical Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John A Rathmacher, PhD

Role: PRINCIPAL_INVESTIGATOR

Metabolic Technologies Inc.

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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R44AG055184

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MTI2018-CS02

Identifier Type: -

Identifier Source: org_study_id