Muscle StrengthPhase 1NCT00874575
Nutritional Intervention for Age-related Muscular Function and Strength Losses
A Phase 1 study testing Vitamin D, Beta-hydroxy-Beta-methylbutyrate and Beta-hydroxy-Beta-methylbutyrate and Vitamin D in people with Muscle Strength and Sarcopenia, run by Metabolic Technologies Inc. at 2 sites in United States.
Trial summary
The purpose of the study is to Test the effect of a dietary supplement beta-hydroxy-beta-methylbutyrate (HMB) with and without Vitamin D to prevent and reverse the losses of muscular strength and functionality in older adults. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Muscle Strength, Sarcopenia
- What is being tested?
- Vitamin D, Beta-hydroxy-Beta-methylbutyrate and Beta-hydroxy-Beta-methylbutyrate and Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2008to Jul 2013
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Subjects must meet all of the inclusion criteria in order to participate in the study.
- Male and Female subjects will be enrolled into the study.
- Age > 60 years.
- Free of liver and kidney diseases, and with no evidence of uncontrolled hypertension.
- Does not have a chronic disease that affects calcium or bone metabolism (i.e., asthma with chronic use of high dose steroids, inflammatory bowel disease, Crohn's disease, primary hyperparathyroidism, seizure disorder with use of phenobarbital, etc.).
- Not classified as morbidly obese (body mass index (BMI) >40 kg/m2).
- Six weeks since major surgery (three weeks since minor surgery).
- Willing to consume one of the nutritional supplements for the study period.
- Individuals diagnosed with osteoporosis (i.e., bone density > 2.5 standard deviations below the mean) will not be enrolled in the study.
- No other serious medical illness.
- Serum 25OH-VitD3 >10 and <25 ng/ml.
- Able and willing to participate in 3-day-a-week monitored strength-training program.
- Physician has placed no restriction on physical exercise.
All candidates meeting any one of the exclusion criteria will not be enrolled into the study and as necessary will be referred to their private physician for further follow-up.
- Age < 60 years.
- Evidence of liver and kidney diseases, uncontrolled hypertension, or Type I diabetes mellitus requiring insulin for glucose control.
- Presence of a chronic disease that affects calcium or bone metabolism (i.e., asthma with chronic use of high dose steroids, inflammatory bowel disease, Crohn's disease, primary hyperparathyroidism, seizure disorder with use of phenobarbital, etc.).
- Classified as morbidly obese (body mass index (BMI) >40 kg/m2).
- Less than six weeks since major surgery or three weeks since minor surgery.
- Not willing to consume one of the nutritional supplements for the study period.
- Individuals diagnosed with osteoporosis (i.e., bone density > 2.5 standard deviations below the mean) will not be enrolled in the study.
- Other serious medical illness, which the subjects doctor or medical review team has decided affects the subject's ability to participate in the study.
- Subjects on high dose vitamin D therapies (i.e. 50,000 IU vitamin D).
- Subjects with serum 25OH-VitD3 <10 ng/ml will be considered deficient and will be referred to their physician for treatment.
- Subjects with serum 25OH-VitD3 >25 ng/ml.
- Not able or willing to participate in 3-day-a-week monitored strength-training program.
- Physician has placed a restriction on physical exercise.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Iowa State University
Ames, Iowa, 50010
South Dakota State University
Brookings, South Dakota, 57007
About this study
Official title: A Double Blind Study on the Efficacy of a Combination of Beta-hydroxy-beta-methylbutyrate and Vitamin D on Muscular Strength and Functionality in Older Adults.
The purpose of the study is to
- Test the effect of a dietary supplement beta-hydroxy-beta-methylbutyrate (HMB) with and without Vitamin D to prevent and reverse the losses of muscular strength and functionality in older adults.
Read more
The second aim of the study is to determine if HMB and Vitamin D improves markers of bone turnover in adults aged 60 plus years. HMB is a dietary supplement that comes from the amino acid leucine. HMB is found in foods and is made in your body after you eat protein (meat). Subjects will be randomized to one of four dietary supplement groups and will participate in a 3-day per week exercise program for 12 weeks. Each exercise day will be about 60 minutes long consisting of strength training exercises utilizing Theraband® stretch cords and jumping.
Subjects will consume the dietary supplement 2 times per day for 12 weeks. Tests will consist of the following:
- Measuring the strength of subjects' legs by using a Isokinetic Dynamometer
- Measuring body composition
- Measuring hand-grip strength using a hand-grip dynamometer
- Measuring functional mobility, balance and agility by the time it takes for you to rise from a chair, walk around a cone 8 feet in front of the chair and return to the chair (Up-\&-Go Test
- Filling out questionnaires and having blood drawn for biochemical measurements. Testing will be performed at the beginning and at 4, 8 and 12 weeks.
- Conditions
- Muscle Strength, Sarcopenia
- Being tested
- Placebo, Vitamin D, Beta-hydroxy-Beta-methylbutyrate, Beta-hydroxy-Beta-methylbutyrate and Vitamin D
- Keywords
- HMB, Vitamin D, Older Adults
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Vitamin DDietary supplement
Also called Cholecalciferol
Beta-hydroxy-Beta-methylbutyrateDietary supplement
Also called HMB
Beta-hydroxy-Beta-methylbutyrate and Vitamin DDrug
Also called Beta-hydroxy-Beta-methylbutyrate: HMB, Vitamin D: Cholecalciferol
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Control Receives: Dietary Supplement: Placebo |
| 2 | Experimental | Beta-hydroxy-Beta-methylbutyrate, 3 g/d Receives: Dietary Supplement: Beta-hydroxy-Beta-methylbutyrate |
| 3 | Experimental | Vitamin D, 2000 IU/d Receives: Dietary Supplement: Vitamin D |
| 4 | Experimental | Beta-hydroxy-Beta-methylbutyrate (3 g/d) + Vitamin D (2000 IU/d) Receives: Drug: Beta-hydroxy-Beta-methylbutyrate and Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscular Strength and functionality
Measured: 12 weeks
Secondary outcomes (1)
Bone turnover
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startNov 2008
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle StrengthStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metabolic Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Iowa State University, South Dakota State University
- Responsible party
- Sponsor
- Investigators
- John A. Rathmacher, Ph.D., Principal investigator, Metabolic Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00874575
- Sponsor's protocol ID
- MTI2008-CS01
- Status last verified
- Sep 2014
- First submitted
- 31 Mar 2009
- Last updated
- 17 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Study on the Efficacy of a Combination of Beta-hydroxy-beta-methylbutyrate and Vitamin D on Muscular Strength and Functionality in Older Adults.
- ClinicalTrials.gov ID
- NCT00874575
- Acronym / sponsor ID
- MTI2008-CS01
- Conditions
- Muscle Strength, Sarcopenia
- Keywords
- HMB, Vitamin D, Older Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Metabolic Technologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- Iowa State University, South Dakota State University
- Study start
- Nov 2008
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 2 Apr 2009 (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 the study is to
- Test the effect of a dietary supplement beta-hydroxy-beta-methylbutyrate (HMB) with and without Vitamin D to prevent and reverse the losses of muscular strength and functionality in older adults.
The second aim of the study is to determine if HMB and Vitamin D improves markers of bone turnover in adults aged 60 plus years. HMB is a dietary supplement that comes from the amino acid leucine. HMB is found in foods and is made in your body after you eat protein (meat). Subjects will be randomized to one of four dietary supplement groups and will participate in a 3-day per week exercise program for 12 weeks. Each exercise day will be about 60 minutes long consisting of strength training exercises utilizing Theraband® stretch cords and jumping.
Subjects will consume the dietary supplement 2 times per day for 12 weeks. Tests will consist of the following:
- Measuring the strength of subjects' legs by using a Isokinetic Dynamometer
- Measuring body composition
- Measuring hand-grip strength using a hand-grip dynamometer
- Measuring functional mobility, balance and agility by the time it takes for you to rise from a chair, walk around a cone 8 feet in front of the chair and return to the chair (Up-\&-Go Test
- Filling out questionnaires and having blood drawn for biochemical measurements. Testing will be performed at the beginning and at 4, 8 and 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Dietary Supplement: PlaceboControl |
| 2 | Experimental | Dietary Supplement: Beta-hydroxy-Beta-methylbutyrateBeta-hydroxy-Beta-methylbutyrate, 3 g/d |
| 3 | Experimental | Dietary Supplement: Vitamin DVitamin D, 2000 IU/d |
| 4 | Experimental | Drug: Beta-hydroxy-Beta-methylbutyrate and Vitamin DBeta-hydroxy-Beta-methylbutyrate (3 g/d) + Vitamin D (2000 IU/d) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Placebo | Dietary supplement | 1 |
| Vitamin DAlso: Cholecalciferol | Dietary supplement | 3 |
| Beta-hydroxy-Beta-methylbutyrateAlso: HMB | Dietary supplement | 2 |
| Beta-hydroxy-Beta-methylbutyrate and Vitamin DAlso: Beta-hydroxy-Beta-methylbutyrate: HMB, Vitamin D: Cholecalciferol | Drug | 4 |
Primary outcome
Muscular Strength and functionality
Time frame: 12 weeks
1 secondary outcome
Bone turnover
Time frame: 12 weeks
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 17 Sep 2014.
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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, Ph.D. principal investigator
Metabolic Technologies
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vitamin D, Beta-hydroxy-Beta-methylbutyrate and Beta-hydroxy-Beta-methylbutyrate and Vitamin D in people with Muscle Strength and Sarcopenia, run by Metabolic Technologies Inc. at 2 sites 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?
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 17 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 2 sites 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?
Muscular Strength and functionality (time frame: 12 weeks). 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 17 Sep 2014.