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Completed

NCT Number: NCT03556319

2-HOBA: Multiple Dosing Study in Older Adults

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.

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Key information

Conditions

Older Adults

Age range

55 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

2-HOBA

Dietary Supplement

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

Other names: 2-Hydroxybenzylamine

Placebo

Dietary Supplement

Placebo Comparator

Primary outcomes

  1. Multiple Dose Tolerability

    Time frame: 15 Days

    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).

Secondary outcomes

  1. Measurement of oxidative protein adducts in platelets

    Time frame: 15 Days

    Oxidative protein adducts will be measured in blood platelets as an indication of efficacy (ng adducted protein/mg protein).

  2. Blood Pressure

    Time frame: 15 Days

    Blood pressure will be measured as an indicator of efficacy against oxidative stress (mm Hg).

  3. Maximum Plasma Concentration (Cmax)

    Time frame: Day 1 and Day 15

    Cmax will be calculated from multiple timed plasma measurements (ng/ml).

  4. Area Under the Curve (AUC)

    Time frame: Day 1 and Day 15

    AUC will be calculated from multiple timed plasma measurements (h*ng/ml).

Sponsors and collaborators

Lead sponsor

Metabolic Technologies Inc.

Industry

Collaborators

  • National Institute on Aging (NIA)
  • Vanderbilt University

Registry information

Official study title

2-Hydroxybenzylamine: Multiple Dosing Study in Older Adults

Acronym: 2-HOBA

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 14, 2018
Registry last updated
Dec 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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