2-HOBA: Multiple Dosing Study in Healthy Humans
- Conditions
- Healthy Volunteers
- Interventions
- Dietary Supplement: 2-HOBADietary Supplement: Placebo
- Registration Number
- NCT03555682
- Lead Sponsor
- Metabolic Technologies Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2-HOBA High Dose 2-HOBA 2-Hydroxybenzylamine acetate: 750mg dose Placebo Placebo Placebo 2-HOBA Low Dose 2-HOBA 2-Hydroxybenzylamine acetate: 500mg dose
- Primary Outcome Measures
Name Time Method Multiple Dose Tolerability 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 Outcome Measures
Name Time Method Maximum Plasma Concentration (Cmax) Day 1 and Day 15 Cmax will be calculated from multiple timed plasma measurements (ng/ml).
Measurement of oxidative protein adducts in platelets 15 Days Oxidative protein adducts will be measured in blood platelets as an indication of efficacy (ng adducted protein/mg protein).
Blood Pressure 15 Days Blood pressure will be measured as an indicator of efficacy against oxidative stress (mm Hg).
Area Under the Curve (AUC) Day 1 and Day 15 AUC will be calculated from multiple timed plasma measurements (hr\*ng/ml).
Trial Locations
- Locations (1)
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States