Older Adults2-HOBANCT03556319
2-HOBA: Multiple Dosing Study in Older Adults
A study testing 2-HOBA in people with Older Adults, run by Metabolic Technologies Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Older Adults
- What is being tested?
- 2-HOBA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2018to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals between 55 and 79 years old with metabolic syndrome
- Men and post-menopausal women.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: 2-Hydroxybenzylamine: Multiple Dosing Study in Older Adults
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.
Read the 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.
- Conditions
- Older Adults
- Being tested
- 2-HOBA, Placebo
- Keywords
- Multiple Dosage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-HOBADietary supplement
Also called 2-Hydroxybenzylamine
2-HOBA is a compound found in buckwheat and is given as 2-HOBA acetate
PlaceboDietary supplement
Placebo Comparator
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
| 2-HOBA Low Dose | Experimental | 2-Hydroxybenzylamine acetate: 500mg dose Receives: Dietary Supplement: 2-HOBA |
| 2-HOBA High Dose | Experimental | 2-Hydroxybenzylamine acetate: 750mg dose Receives: Dietary Supplement: 2-HOBA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple Dose Tolerability
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).
Measured: 15 Days
Secondary outcomes (4)
Measurement of oxidative protein adducts in platelets
Oxidative protein adducts will be measured in blood platelets as an indication of efficacy (ng adducted protein/mg protein).
Measured: 15 Days
Blood Pressure
Blood pressure will be measured as an indicator of efficacy against oxidative stress (mm Hg).
Measured: 15 Days
Maximum Plasma Concentration (Cmax)
Cmax will be calculated from multiple timed plasma measurements (ng/ml).
Measured: Day 1 and Day 15
Area Under the Curve (AUC)
AUC will be calculated from multiple timed plasma measurements (h*ng/ml).
Measured: Day 1 and Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start23 May 2018
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metabolic Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vanderbilt University, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, John Rathmacher, PhD, Metabolic Technologies Inc.
- Investigators
- John A Rathmacher, PhD, Principal investigator, Metabolic Technologies Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556319
- Sponsor's protocol ID
- MTI2018-CS02
- Other IDs
- R44AG055184
- Acronym
- 2-HOBA
- Status last verified
- Dec 2021
- First submitted
- 29 May 2018
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2-Hydroxybenzylamine: Multiple Dosing Study in Older Adults
- ClinicalTrials.gov ID
- NCT03556319
- Acronym / sponsor ID
- 2-HOBA / MTI2018-CS02
- Conditions
- Older Adults
- Keywords
- Multiple Dosage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Metabolic Technologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- Vanderbilt University, National Institute on Aging (NIA)
- Study start
- 23 May 2018 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 14 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
| 2-HOBA Low Dose | Experimental | Dietary Supplement: 2-HOBA2-Hydroxybenzylamine acetate: 500mg dose |
| 2-HOBA High Dose | Experimental | Dietary Supplement: 2-HOBA2-Hydroxybenzylamine acetate: 750mg dose |
Who may qualify
- Ages
- 55 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals between 55 and 79 years old with metabolic syndrome
- Men and post-menopausal women.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2-HOBAAlso: 2-Hydroxybenzylamine2-HOBA is a compound found in buckwheat and is given as 2-HOBA acetate | Dietary supplement | 2-HOBA High Dose, 2-HOBA Low Dose |
| PlaceboPlacebo Comparator | Dietary supplement | Placebo |
Primary outcome
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).
4 secondary outcomes
Measurement of oxidative protein adducts in platelets
Time frame: 15 Days
Blood Pressure
Time frame: 15 Days
Maximum Plasma Concentration (Cmax)
Time frame: Day 1 and Day 15
Area Under the Curve (AUC)
Time frame: Day 1 and Day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John A Rathmacher, PhD principal investigator
Metabolic Technologies Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2-HOBA in people with Older Adults, run by Metabolic Technologies Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multiple Dose Tolerability (time frame: 15 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2021.