HealthyPhase 1NCT01150526
Efficacy of a New Delivery System for Beta-hydroxy-beta-methylbutyrate
A Phase 1 study testing CaHMB and HMB Free Acid Gel in people with Healthy, run by Metabolic Technologies Inc. at 1 site in United States.
Trial summary
The proposed study will test efficacy of HMB in free acid gel to decrease muscle damage, diminish inflammatory response, and improve muscle strength recovery following an acute exercise stress. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CaHMB and HMB Free Acid Gel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jul 2012
- Phase
- Phase 1
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must live within 50 miles of Ames, Iowa
- Free of cardiac, liver, pulmonary, and kidney disease
- Free of chronic inflammatory disease including rheumatoid arthritis, osteoarthritis, inflammatory bowel disease, and psoriasis
- Free diabetes mellitus
- Not classified as morbidly obese (BMI must be less than 40)
- Free of cardiac, liver, pulmonary, and kidney disease
Show all 9Show fewer
- No other serious medical illness
- Normal menstrual cycle and not pregnant or lactating
- Able to consume supplements and perform required exercise testing
Who cannot join
- Live more than 50 miles from Ames, Iowa
- Presence of cardiac, liver, pulmonary, and kidney disease
- Presence of chronic inflammatory disease including rheumatoid arthritis, osteoarthritis, inflammatory bowel disease, and psoriasis
- Diabetes mellitus
- Classified as morbidly obese (BMI is greater than 40)
- No other serious medical illness
- Abnormal menstrual cycle, pregnant or lactating
- Not able to consume supplements and perform required exercise testing
Trial locations and contacts
1 site in 1 country.
About this study
The proposed study will test efficacy of HMB in free acid gel to decrease muscle damage, diminish inflammatory response, and improve muscle strength recovery following an acute exercise stress. HMB in a free acid gel or in CaHMB capsule form will be administered as either a single dose before a bout of acute exercise or in multiple doses (one before and three daily doses for the 4 days following the acute exercise). We hypothesize that HMB in free acid gel will result in less muscle damage, diminished inflammatory response, and improved muscle strength recovery than either a placebo or CaHMB treatment following a bout of acute eccentric exercise. Our endpoints will include measurements of: (1) markers for muscle damage (CPK and LDH); (2) indicators of inflammation (CRP, TNF-α, IL-6, IL-1ra and IL-18); and (3) muscle strength recovery and soreness.
- Conditions
- Healthy
- Being tested
- CaHMB, HMB Free Acid Gel, Placebo, Placebo Gel Dosage
- Keywords
- Acute Exercise, Muscle Inflammation, CaHMB, HMB Free Acid Gel, Healthy Subjects
- Medical subject headings
- Myositis, Inclusion Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaHMBDietary supplement
CaHMB capsules with each capsule containing 0.8 g of HMB
HMB Free Acid GelDietary supplement
HMB Free acid in a gel form with each dose supplying 0.8 g of HMB free acid
PlaceboDietary supplement
Placebo capsules similar in size and color to the CaHMB capsules used in the study
Placebo Gel DosageDietary supplement
A corn syrup based placebo with flavoring and taste similar to the HMB Free Acid Gel
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Oral Placebo capsule and one placebo gel dosage given 30 min prior to the acute exercise session. A placebo capsule and placebo gel dosage are then administered 3 times daily during the remainder of the study. Receives: Dietary Supplement: Placebo; Dietary Supplement: Placebo Gel Dosage |
| CaHMB Pre | Experimental | Oral CaHMB capsule and one placebo gel dosage given 30 min prior to the acute exercise session. A placebo capsule and placebo gel dosage are then administered 3 times daily during the remainder of the study. Receives: Dietary Supplement: CaHMB; Dietary Supplement: Placebo; Dietary Supplement: Placebo Gel Dosage |
| CaHMB Pre and Post | Experimental | Oral CaHMB capsule and one placebo gel dosage given 30 min prior to the acute exercise session. A CaHMB capsule and placebo gel dosage are are then administered 3 times daily during the remainder of the study. Receives: Dietary Supplement: CaHMB; Dietary Supplement: Placebo Gel Dosage |
| HMB Free Acid Gel Pre | Experimental | Oral placebo capsule and one HMB free acid gel dosage given 30 min prior to the acute exercise session. A placebo capsule and placebo gel dosage are then administered 3 times daily during the remainder of the study. Receives: Dietary Supplement: HMB Free Acid Gel; Dietary Supplement: Placebo; Dietary Supplement: Placebo Gel Dosage |
| HMB Free Acid Gel Pre and Post | Experimental | Oral placebo capsule and one HMB free acid gel dosage given 30 min prior to the acute exercise session. A placebo capsule and HMB free acid gel dosage are then administered 3 times daily during the remainder of the study. Receives: Dietary Supplement: HMB Free Acid Gel; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in muscle damage and inflammation
Serum analysis for markers of muscle damage (CPK) and inflammation (IL-6, IL-18, IL1ra, TNF-a, CRP) will be measured at 24, 48, 72, and 96 h post exercise bout
Measured: 4 days post eccentric exercise bout
Secondary outcomes (1)
Improvement in strength recovery and decrease in soreness
Muscle strength recovery and soreness will be measured at 24, 48, 72, and 96 h post exercise bout.
Measured: 4 days post eccentric exercise bout
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2010 (estimated)
- Study startOct 2010
- Primary completionNov 2010
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metabolic Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Iowa State University
- Responsible party
- Sponsor
- Investigators
- John A Rathmacher, PhD, Principal investigator, Metabolic Technologies Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150526
- Sponsor's protocol ID
- MTI2010-CS02
- Status last verified
- Jul 2012
- First submitted
- 23 Jun 2010
- Last updated
- 18 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a New Delivery System for Beta-hydroxy-beta-methylbutyrate
- ClinicalTrials.gov ID
- NCT01150526
- Acronym / sponsor ID
- MTI2010-CS02
- Conditions
- Healthy
- Keywords
- Acute Exercise, Muscle Inflammation, CaHMB, HMB Free Acid Gel, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Metabolic Technologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- Iowa State University
- Study start
- Oct 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 25 Jun 2010 (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 proposed study will test efficacy of HMB in free acid gel to decrease muscle damage, diminish inflammatory response, and improve muscle strength recovery following an acute exercise stress. HMB in a free acid gel or in CaHMB capsule form will be administered as either a single dose before a bout of acute exercise or in multiple doses (one before and three daily doses for the 4 days following the acute exercise). We hypothesize that HMB in free acid gel will result in less muscle damage, diminished inflammatory response, and improved muscle strength recovery than either a placebo or CaHMB treatment following a bout of acute eccentric exercise. Our endpoints will include measurements of: (1) markers for muscle damage (CPK and LDH); (2) indicators of inflammation (CRP, TNF-α, IL-6, IL-1ra and IL-18); and (3) muscle strength recovery and soreness.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo, Dietary Supplement: Placebo Gel DosageOral Placebo capsule and one placebo gel dosage given 30 min prior to the acute exercise session. A placebo capsule and placebo gel dosage are then administered 3 times daily during the remainder of the study. |
| CaHMB Pre | Experimental | Dietary Supplement: CaHMB, Dietary Supplement: Placebo, Dietary Supplement: Placebo Gel DosageOral CaHMB capsule and one placebo gel dosage given 30 min prior to the acute exercise session. A placebo capsule and placebo gel dosage are then administered 3 times daily during the remainder of the study. |
| CaHMB Pre and Post | Experimental | Dietary Supplement: CaHMB, Dietary Supplement: Placebo Gel DosageOral CaHMB capsule and one placebo gel dosage given 30 min prior to the acute exercise session. A CaHMB capsule and placebo gel dosage are are then administered 3 times daily during the remainder of the study. |
| HMB Free Acid Gel Pre | Experimental | Dietary Supplement: HMB Free Acid Gel, Dietary Supplement: Placebo, Dietary Supplement: Placebo Gel DosageOral placebo capsule and one HMB free acid gel dosage given 30 min prior to the acute exercise session. A placebo capsule and placebo gel dosage are then administered 3 times daily during the remainder of the study. |
| HMB Free Acid Gel Pre and Post | Experimental | Dietary Supplement: HMB Free Acid Gel, Dietary Supplement: PlaceboOral placebo capsule and one HMB free acid gel dosage given 30 min prior to the acute exercise session. A placebo capsule and HMB free acid gel dosage are then administered 3 times daily during the remainder of the study. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Must live within 50 miles of Ames, Iowa
- Free of cardiac, liver, pulmonary, and kidney disease
- Free of chronic inflammatory disease including rheumatoid arthritis, osteoarthritis, inflammatory bowel disease, and psoriasis
- Free diabetes mellitus
- Not classified as morbidly obese (BMI must be less than 40)
Key exclusion criteria (8 listed)
- Live more than 50 miles from Ames, Iowa
- Presence of cardiac, liver, pulmonary, and kidney disease
- Presence of chronic inflammatory disease including rheumatoid arthritis, osteoarthritis, inflammatory bowel disease, and psoriasis
- Diabetes mellitus
- Classified as morbidly obese (BMI is greater than 40)
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 |
|---|---|---|
| CaHMBCaHMB capsules with each capsule containing 0.8 g of HMB | Dietary supplement | CaHMB Pre, CaHMB Pre and Post |
| HMB Free Acid GelHMB Free acid in a gel form with each dose supplying 0.8 g of HMB free acid | Dietary supplement | HMB Free Acid Gel Pre, HMB Free Acid Gel Pre and Post |
| PlaceboPlacebo capsules similar in size and color to the CaHMB capsules used in the study | Dietary supplement | CaHMB Pre, HMB Free Acid Gel Pre, HMB Free Acid Gel Pre and Post, Placebo |
| Placebo Gel DosageA corn syrup based placebo with flavoring and taste similar to the HMB Free Acid Gel | Dietary supplement | CaHMB Pre, CaHMB Pre and Post, HMB Free Acid Gel Pre, Placebo |
Primary outcome
Decrease in muscle damage and inflammation
Time frame: 4 days post eccentric exercise bout
Serum analysis for markers of muscle damage (CPK) and inflammation (IL-6, IL-18, IL1ra, TNF-a, CRP) will be measured at 24, 48, 72, and 96 h post exercise bout
1 secondary outcome
Improvement in strength recovery and decrease in soreness
Time frame: 4 days post eccentric exercise bout
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 18 Jul 2012.
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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 Phase 1 study testing CaHMB and HMB Free Acid Gel in people with Healthy, 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 9 inclusion and 8 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 18 Jul 2012. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Decrease in muscle damage and inflammation (time frame: 4 days post eccentric exercise bout). 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 18 Jul 2012.