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2-HOBA: Multiple Dosing Study in Older Adults (2-HOBA)

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ClinicalTrials.gov Identifier: NCT03556319
Recruitment Status : Recruiting
First Posted : June 14, 2018
Last Update Posted : August 13, 2019
Sponsor:
Collaborators:
Vanderbilt University
National Institute on Aging (NIA)
Information provided by (Responsible Party):
John Rathmacher, PhD, 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.

Condition or disease Intervention/treatment Phase
Older Adults Dietary Supplement: 2-HOBA Dietary Supplement: Placebo Not Applicable

Detailed Description:

Consenting volunteers between 60 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: 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.
Primary Purpose: Basic Science
Official Title: 2-Hydroxybenzylamine: Multiple Dosing Study in Older Adults
Actual Study Start Date : May 23, 2018
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : November 1, 2019

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Dietary Supplement: Placebo
Placebo Comparator

Experimental: 2-HOBA Low Dose
2-Hydroxybenzylamine acetate: 500mg dose
Dietary Supplement: 2-HOBA
2-HOBA is a compound found in buckwheat and is given as 2-HOBA acetate
Other Name: 2-Hydroxybenzylamine

Experimental: 2-HOBA High Dose
2-Hydroxybenzylamine acetate: 750mg dose
Dietary Supplement: 2-HOBA
2-HOBA is a compound found in buckwheat and is given as 2-HOBA acetate
Other Name: 2-Hydroxybenzylamine




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   60 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Individuals between 60 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03556319


Contacts
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Contact: Patricia M Currey, RN 615-322-4721 patricia.m.macleod-welsh@Vanderbilt.edu

Locations
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United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Patricia M Currey, RN    615-322-4721    patricia.m.macleod-welsh@Vanderbilt.Edu   
Sponsors and Collaborators
Metabolic Technologies Inc.
Vanderbilt University
National Institute on Aging (NIA)
Investigators
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Principal Investigator: John A Rathmacher, PhD Metabolic Technologies Inc.

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Responsible Party: John Rathmacher, PhD, Director of Clinical Research, Metabolic Technologies Inc.
ClinicalTrials.gov Identifier: NCT03556319     History of Changes
Other Study ID Numbers: MTI2018-CS02
R44AG055184 ( U.S. NIH Grant/Contract )
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by John Rathmacher, PhD, Metabolic Technologies Inc.:
Multiple Dosage