2-HOBA: Multiple Dosing Study in Older Adults

NCT03556319 | Completed DMC

• 2 other identifiers: MTI2018-CS02R44AG055184
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Older Adults

Keywords

Multiple Dosage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Measurement of oxidative protein adducts in platelets

  15 Days

• Blood Pressure

  15 Days

• Maximum Plasma Concentration (Cmax)

  Day 1 and Day 15

• Area Under the Curve (AUC)

  Day 1 and Day 15

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

2-HOBA Low Dose

EXPERIMENTAL

2-Hydroxybenzylamine acetate: 500mg dose

Dietary Supplement: 2-HOBA

2-HOBA High Dose

EXPERIMENTAL

2-Hydroxybenzylamine acetate: 750mg dose

Dietary Supplement: 2-HOBA

Interventions

2-HOBA DIETARY_SUPPLEMENT

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

Also known as: 2-Hydroxybenzylamine

2-HOBA High Dose; 2-HOBA Low Dose

Placebo DIETARY_SUPPLEMENT

Placebo Comparator

Placebo

Eligibility Criteria

• Age: 55 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Metabolic Technologies Inc.: lead
• Vanderbilt University: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Interventions

2-(aminomethyl)phenol

Study Officials

• John A Rathmacher, PhD

  Metabolic Technologies Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research

Model Details: 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.

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 14, 2018
• Study Start: May 23, 2018
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: December 14, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)