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Trial record 1 of 1 for:    NCT03556319
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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 : June 17, 2020
Sponsor:
Collaborators:
Vanderbilt University
National Institute on Aging (NIA)
Information provided by (Responsible Party):
John Rathmacher, PhD, Metabolic Technologies Inc.

Tracking Information
First Submitted Date  ICMJE May 29, 2018
First Posted Date  ICMJE June 14, 2018
Last Update Posted Date June 17, 2020
Actual Study Start Date  ICMJE May 23, 2018
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2018)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2018)
  • 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).
  • Blood Pressure [ Time Frame: 15 Days ]
    Blood pressure will be measured as an indicator of efficacy against oxidative stress (mm Hg).
  • Maximum Plasma Concentration (Cmax) [ Time Frame: Day 1 and Day 15 ]
    Cmax will be calculated from multiple timed plasma measurements (ng/ml).
  • Area Under the Curve (AUC) [ Time Frame: Day 1 and Day 15 ]
    AUC will be calculated from multiple timed plasma measurements (h*ng/ml).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 2-HOBA: Multiple Dosing Study in Older Adults
Official Title  ICMJE 2-Hydroxybenzylamine: Multiple Dosing Study in Older Adults
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Older Adults
Intervention  ICMJE
  • Dietary Supplement: 2-HOBA
    2-HOBA is a compound found in buckwheat and is given as 2-HOBA acetate
    Other Name: 2-Hydroxybenzylamine
  • Dietary Supplement: Placebo
    Placebo Comparator
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Dietary Supplement: Placebo
  • Experimental: 2-HOBA Low Dose
    2-Hydroxybenzylamine acetate: 500mg dose
    Intervention: Dietary Supplement: 2-HOBA
  • Experimental: 2-HOBA High Dose
    2-Hydroxybenzylamine acetate: 750mg dose
    Intervention: Dietary Supplement: 2-HOBA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 12, 2018)
23
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2020
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Patricia C Driver, RN 615-322-4721 patricia.m.macleod-welsh@vumc.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03556319
Other Study ID Numbers  ICMJE MTI2018-CS02
R44AG055184 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party John Rathmacher, PhD, Metabolic Technologies Inc.
Study Sponsor  ICMJE Metabolic Technologies Inc.
Collaborators  ICMJE
  • Vanderbilt University
  • National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: John A Rathmacher, PhD Metabolic Technologies Inc.
PRS Account Metabolic Technologies Inc.
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP