Focus of the Study is to Examine Plasma HMB Levels After Oral HMB SupplementationNCT01914952
Alternate Dosing Strategies for Beta-hydroxy-beta-methylbutyrate (HMB) Supplementation: Effect on Plasma HMB Responses
A study testing CaHMB capsule, HMB free acid gelcap and HMB free acid mixed in water in people with Focus of the Study is to Examine Plasma HMB Levels After Oral HMB Supplementation, run by Metabolic Technologies Inc. at 1 site in United States.
Trial summary
The purpose of this study is to examine the rise in plasma Beta-hydroxy-beta-methylbutyrate (HMB) after the dietary supplement has been administered in different forms. Prior studies have indicated that form of administration affects bioavailability of the HMB supplement. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Focus of the Study is to Examine Plasma HMB Levels After Oral HMB Supplementation
- What is being tested?
- CaHMB capsule, HMB free acid gelcap and HMB free acid mixed in water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to May 2014
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must not be taking amino acid, protein, or HMB supplements; Must not be pregnant; Must not be breastfeeding
Who cannot join
- Currently taking amino acid, protein, or HMB supplements; Currently pregnant; Currently breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine the rise in plasma Beta-hydroxy-beta-methylbutyrate (HMB) after the dietary supplement has been administered in different forms. Prior studies have indicated that form of administration affects bioavailability of the HMB supplement. Therefore the current study will examine the bioavailability of a single dose of HMB given as:
- 1.0g CaHMB in gelatin capsule
- 0.8 g HMB free acid in a gelcap
- 0.8 g HMB free acid in water
- 1.0 g CaHMB in water
- 0.8 g HMB free acid
The randomized study will be a crossover design and each study subject will undergo the experimental protocol for each of the supplementation forms. Because of the different administration forms, the study will be an open label study. Briefly, the fasted participants will report to the laboratory in the morning. After an initial blood sample is taken, the dose of HMB will be administered. Blood will then be samples at 2, 5, 10, 15, 25, 35, 45, 60, 90, 120, 180, 360, 720, and 1440 min post administration. A 24 h complete urine collection will also be performed. Participants will be given a light sack lunch 4 h after administration of the dosage and will remain at the laboratory through the 360 min sampling. Participants will then be allowed to leave the laboratory and return for the 720 min sampling after which the participants can eat an normal evening meal. Participants will return to the laboratory fasted the next morning for the final sample. A minimum 48 h washout period will be required before the next dosage form is administered and the process repeated.
- Being tested
- CaHMB capsule, HMB free acid gelcap, HMB free acid mixed in water, CaHMB in water, HMB free acid
- Keywords
- CaHMB, HMB free acid, HMB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaHMB capsuleDietary supplement
1.0 gram of CaHMB powder in a gelatin capsule
HMB free acid gelcapDietary supplement
0.8 g HMB free acid is a soft gel capsule
HMB free acid mixed in waterDietary supplement
0.8 g HMB free acid in water
CaHMB in waterDietary supplement
1.0 g CaHMB powder mixed in water
HMB free acidDietary supplement
0.8 g HMB free acid
| Study group | Role | What they receive |
|---|---|---|
| CaHMB Capsule | Active comparator | Not described Receives: Dietary Supplement: CaHMB capsule |
| HMB free acid gelcap | Active comparator | Not described Receives: Dietary Supplement: HMB free acid gelcap |
| HMB free acid in water | Active comparator | Not described Receives: Dietary Supplement: HMB free acid mixed in water |
| CaHMB powder in water | Active comparator | Not described Receives: Dietary Supplement: CaHMB in water |
| HMB free acid (oral not in gelcap or water) | Active comparator | Not described Receives: Dietary Supplement: HMB free acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma HMB Level
Measured: Plasma samples collected at 0, 2, 5, 10, 15, 25, 35, 45, 60, 90, 120, 180, 360, 720, and 1440 min after treatment administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus of the Study is to Examine Plasma HMB Levels After Oral HMB SupplementationStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metabolic Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914952
- Sponsor's protocol ID
- MTI2013-CS02
- Status last verified
- Sep 2014
- First submitted
- 31 Jul 2013
- Last updated
- 16 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternate Dosing Strategies for Beta-hydroxy-beta-methylbutyrate (HMB) Supplementation: Effect on Plasma HMB Responses
- ClinicalTrials.gov ID
- NCT01914952
- Acronym / sponsor ID
- MTI2013-CS02
- Keywords
- CaHMB, HMB free acid, HMB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Metabolic Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 2 Aug 2013 (estimated)
- 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 examine the rise in plasma Beta-hydroxy-beta-methylbutyrate (HMB) after the dietary supplement has been administered in different forms. Prior studies have indicated that form of administration affects bioavailability of the HMB supplement. Therefore the current study will examine the bioavailability of a single dose of HMB given as:
- 1.0g CaHMB in gelatin capsule
- 0.8 g HMB free acid in a gelcap
- 0.8 g HMB free acid in water
- 1.0 g CaHMB in water
- 0.8 g HMB free acid
The randomized study will be a crossover design and each study subject will undergo the experimental protocol for each of the supplementation forms. Because of the different administration forms, the study will be an open label study. Briefly, the fasted participants will report to the laboratory in the morning. After an initial blood sample is taken, the dose of HMB will be administered. Blood will then be samples at 2, 5, 10, 15, 25, 35, 45, 60, 90, 120, 180, 360, 720, and 1440 min post administration. A 24 h complete urine collection will also be performed. Participants will be given a light sack lunch 4 h after administration of the dosage and will remain at the laboratory through the 360 min sampling. Participants will then be allowed to leave the laboratory and return for the 720 min sampling after which the participants can eat an normal evening meal. Participants will return to the laboratory fasted the next morning for the final sample. A minimum 48 h washout period will be required before the next dosage form is administered and the process repeated.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CaHMB Capsule | Active comparator | Dietary Supplement: CaHMB capsule |
| HMB free acid gelcap | Active comparator | Dietary Supplement: HMB free acid gelcap |
| HMB free acid in water | Active comparator | Dietary Supplement: HMB free acid mixed in water |
| CaHMB powder in water | Active comparator | Dietary Supplement: CaHMB in water |
| HMB free acid (oral not in gelcap or water) | Active comparator | Dietary Supplement: HMB free acid |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Must not be taking amino acid, protein, or HMB supplements; Must not be pregnant; Must not be breastfeeding
Key exclusion criteria (1 listed)
- Currently taking amino acid, protein, or HMB supplements; Currently pregnant; Currently breastfeeding
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 |
|---|---|---|
| CaHMB capsule1.0 gram of CaHMB powder in a gelatin capsule | Dietary supplement | CaHMB Capsule |
| HMB free acid gelcap0.8 g HMB free acid is a soft gel capsule | Dietary supplement | HMB free acid gelcap |
| HMB free acid mixed in water0.8 g HMB free acid in water | Dietary supplement | HMB free acid in water |
| CaHMB in water1.0 g CaHMB powder mixed in water | Dietary supplement | CaHMB powder in water |
| HMB free acid0.8 g HMB free acid | Dietary supplement | HMB free acid (oral not in gelcap or water) |
Primary outcome
Plasma HMB Level
Time frame: Plasma samples collected at 0, 2, 5, 10, 15, 25, 35, 45, 60, 90, 120, 180, 360, 720, and 1440 min after treatment administration
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 16 Sep 2014.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CaHMB capsule, HMB free acid gelcap and HMB free acid mixed in water in people with Focus of the Study is to Examine Plasma HMB Levels After Oral HMB Supplementation, 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 1 inclusion and 1 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 16 Sep 2014. 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. 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?
Plasma HMB Level (time frame: Plasma samples collected at 0, 2, 5, 10, 15, 25, 35, 45, 60, 90, 120, 180, 360, 720, and 1440 min after treatment administration). 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 16 Sep 2014; AzTrials last refreshed its copy on 6 Nov 2026.