Expired Study
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Nashville, Tennessee 37232


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - 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. 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 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 is Available At:


Original ID:

MTI2018-CS01


NCT ID:

NCT03555682


Secondary ID:

R44AG055184


Study Acronym:

2-HOBA


Brief Title:

2-HOBA: Multiple Dosing Study in Healthy Humans


Official Title:

2-Hydroxybenzylamine: Multiple Dosing Study in Healthy Humans


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

59 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Metabolic Technologies Inc.


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

18


Enrollment Type:

Actual


Overall Contact Information

Official Name:John A Rathmacher, PhD
Principal Investigator
Metabolic Technologies Inc.

Study Dates

Start Date:May 23, 2018
Completion Date:May 10, 2019
Completion Type:Actual
Primary Completion Date:May 10, 2019
Primary Completion Type:Actual
Verification Date:August 2019
Last Changed Date:August 12, 2019
First Received Date:May 29, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Area Under the Curve (AUC)
Time Frame:Day 1 and Day 15
Safety Issues:False
Description:AUC will be calculated from multiple timed plasma measurements (hr*ng/ml).
Outcome Type:Secondary Outcome
Measure:Maximum Plasma Concentration (Cmax)
Time Frame:Day 1 and Day 15
Safety Issues:False
Description:Cmax will be calculated from multiple timed plasma measurements (ng/ml).
Outcome Type:Secondary Outcome
Measure:Blood Pressure
Time Frame:15 Days
Safety Issues:False
Description:Blood pressure will be measured as an indicator of efficacy against oxidative stress (mm Hg).
Outcome Type:Secondary Outcome
Measure:Measurement of oxidative protein adducts in platelets
Time Frame:15 Days
Safety Issues:False
Description:Oxidative protein adducts will be measured in blood platelets as an indication of efficacy (ng adducted protein/mg protein).
Outcome Type:Primary Outcome
Measure:Multiple Dose Tolerability
Time Frame:15 Days
Safety Issues:False
Description: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).

Study Interventions

Intervention Type:Dietary Supplement
Name:2-HOBA
Description:2-HOBA is a compound found in buckwheat and is given as 2-HOBA acetate
Arm Name:2-HOBA Low Dose
Other Name:2-Hydroxybenzylamine
Intervention Type:Dietary Supplement
Name:Placebo
Description:Placebo Comparator
Arm Name:Placebo

Study Arms

Study Arm Type:Experimental
Arm Name:2-HOBA High Dose
Description:2-Hydroxybenzylamine acetate: 750mg dose
Study Arm Type:Experimental
Arm Name:2-HOBA Low Dose
Description:2-Hydroxybenzylamine acetate: 500mg dose
Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Placebo

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Metabolic Technologies Inc.
Agency Class:Other
Agency Type:Collaborator
Agency Name:Vanderbilt University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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