Clinical trial NCT03556319: 2-HOBA: Multiple Dosing Study in Older Adults
Official title: 2-Hydroxybenzylamine: Multiple Dosing Study in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older Adults
Keywords: Multiple Dosage
Lead sponsor: Metabolic Technologies Inc.
Sponsor class: INDUSTRY
Collaborators: name: Vanderbilt University
name: National Institute on Aging (NIA)
First posted: 2018-06-14
Enrollment: 18
Sex: ALL
Minimum age (years): 55
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: BASIC_SCIENCE

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Multiple Dose Tolerability
timeFrame: 15 Days
Secondary outcomes:
measure: Measurement of oxidative protein adducts in platelets
timeFrame: 15 Days
measure: Blood Pressure
timeFrame: 15 Days
measure: Maximum Plasma Concentration (Cmax)
timeFrame: Day 1 and Day 15
measure: Area Under the Curve (AUC)
timeFrame: Day 1 and Day 15
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Metabolic Technologies Inc.
name: John A Rathmacher, PhD
role: PRINCIPAL_INVESTIGATOR
References: