- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03556319
2-HOBA: Multiple Dosing Study in Older Adults (2-HOBA)
2-Hydroxybenzylamine: Multiple Dosing Study in Older Adults
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Placebo Comparator
|
Experimental: 2-HOBA Low Dose
2-Hydroxybenzylamine acetate: 500mg dose
|
2-HOBA is a compound found in buckwheat and is given as 2-HOBA acetate
Other Names:
|
Experimental: 2-HOBA High Dose
2-Hydroxybenzylamine acetate: 750mg dose
|
2-HOBA is a compound found in buckwheat and is given as 2-HOBA acetate
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
15 Days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
15 Days
|
Blood Pressure
Time Frame: 15 Days
|
Blood pressure will be measured as an indicator of efficacy against oxidative stress (mm Hg).
|
15 Days
|
Maximum Plasma Concentration (Cmax)
Time Frame: Day 1 and Day 15
|
Cmax will be calculated from multiple timed plasma measurements (ng/ml).
|
Day 1 and Day 15
|
Area Under the Curve (AUC)
Time Frame: Day 1 and Day 15
|
AUC will be calculated from multiple timed plasma measurements (h*ng/ml).
|
Day 1 and Day 15
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John A Rathmacher, PhD, Metabolic Technologies Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MTI2018-CS02
- R44AG055184 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Older Adults
-
KU LeuvenCompletedHealthy Older Adults | Ill Older AdultsBelgium
-
University of Alabama at BirminghamRecruiting
-
University of HaifaNot yet recruiting
-
University of ReadingCompletedOlder AdultsUnited Kingdom
-
Riphah International UniversityCompleted
-
East Carolina UniversityCompleted
-
Selçuk UniversityCompleted
-
The Hospital for Sick ChildrenCompleted
-
Ohio State UniversityCompleted
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States