SarcopeniaPhase 1NCT02043171
Nutritional Intervention for Age-related Muscular Function and Strength Losses-Study 2
A Phase 1 study testing HMB plus Vitamin D, Non-Exercise and Exercise in people with Sarcopenia, run by Metabolic Technologies Inc. at 1 site in United States.
Trial summary
Men and women lose muscle mass and strength with age. Loss of muscle mass and strength is accompanied by a loss of muscle function which can lead to diminished quality of life and more importantly can lead to serious fall requiring medical treatment. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- HMB plus Vitamin D, Non-Exercise and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 238 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to 4 Feb 2019
- 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
Who may be able to join
- 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).
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- Willing to consume one of the nutritional supplements for the study period.
- Individuals diagnosed with osteoporosis, or bone density > 2.0 standard deviations below the mean, will not be enrolled in the study.
- No other serious medical illness.
- Serum 25OH-vitD3 >15 ng/ml.
- Willing to participate in 3-day-a-week monitored strength-training program.
- Physician has placed no restriction on physical exercise.
Who cannot join
- 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.
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- Individuals diagnosed with osteoporosis, or a bone density > 2.0 standard deviations below the mean, will not be enrolled in the study.
- Other serious medical illness, which the subject's doctor or medical review team has decided affects the subject's ability to participate in the study.
- History of blood clots and/or the use of blood thinning medications
- 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 >30 ng/ml may not respond to the intervention as expected and will also be excluded from the study.
- 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
1 site in 1 country.
About this study
Official title: Year-long Double Blind Study on the Efficacy of a Combination of Beta-hydroxy-beta-methylbutyrate and Vitamin D With and Without Exercise on Muscular Strength and Functionality in Older Adults.
Men and women lose muscle mass and strength with age. Loss of muscle mass and strength is accompanied by a loss of muscle function which can lead to diminished quality of life and more importantly can lead to serious fall requiring medical treatment. The investigators hypothesize that the combined supplements of Calcium-HMB and Vitamin D will lead to decreased falls and to improved quality of life (QOL) for older adults. The investigators further hypothesize that the addition of a modest exercise regimen to these supplements will enhance the synergistic effects of both Calcium-HMB and Vitamin D.
Subjects will consume the dietary supplement 2 times per day for 12 months. Tests will consist of the following: a) strength of subjects' legs and elbow by Isokinetic Dynamometer; b) body composition; c) hand-grip strength by hand-grip dynamometer; d) functional mobility, balance and agility (Get-Up and Get-Up-and-Go tests); e) filling out questionnaires; and g) having blood drawn for biochemical measurements. Testing will be performed at the baseline (0 months) and at 3, 6, 9, and 12 months.
- Conditions
- Sarcopenia
- Being tested
- Placebo, HMB plus Vitamin D, Non-Exercise, Exercise
- 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
A Placebo comparator
HMB plus Vitamin DDrug
Also called HMB (Calcium beta-hydroxy-beta-methylbutyrate), Vitamin D (Cholecalciferol)
Active comparator of HMB (3 g/d) plus Vitamin D (2,000 IU/d)
Non-ExerciseBehavioural
This group will not participate in 3 times per week strength training
ExerciseBehavioural
This group will participate in a supervised 3 times per week strength training program
| Study group | Role | What they receive |
|---|---|---|
| Placebo Exercise | Placebo comparator | Placebo supplementation group with 3 days per week of exercise Receives: Dietary Supplement: Placebo; Behavioral: Exercise |
| Placebo Non-exercise | Placebo comparator | Placebo supplementation group without exercise Receives: Dietary Supplement: Placebo; Behavioral: Non-Exercise |
| HMB plus Vitamin D Exercise | Active comparator | HMB plus Vitamin D supplementation group with 3 days per week of exercise Receives: Drug: HMB plus Vitamin D; Behavioral: Exercise |
| HMB plus Vitamin D Non-exercise | Active comparator | HMB plus Vitamin D supplementation group without exercise Receives: Drug: HMB plus Vitamin D; Behavioral: Non-Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscular strength
Leg and elbow strength will be tested by Isokinetic dynamometer and Handgrip strength will be tested using a hand-grip dynamometer.
Measured: 12 Months
Secondary outcomes (1)
Functionality
The Get-Up and Get-Up-and-Go tests will be used as a measure of functionality.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startAug 2014
- Primary completion4 Feb 2019
- Study completion4 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 238 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
- NCT02043171
- Sponsor's protocol ID
- MTI2014-CS01
- Status last verified
- Feb 2019
- First submitted
- 17 Jan 2014
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Year-long Double Blind Study on the Efficacy of a Combination of Beta-hydroxy-beta-methylbutyrate and Vitamin D With and Without Exercise on Muscular Strength and Functionality in Older Adults.
- ClinicalTrials.gov ID
- NCT02043171
- Acronym / sponsor ID
- MTI2014-CS01
- Conditions
- Sarcopenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Metabolic Technologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- Iowa State University
- Study start
- Aug 2014 (actual)
- Primary completion
- 4 Feb 2019 (actual)
- Study completion
- 4 Feb 2019 (actual)
- First posted
- 23 Jan 2014 (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.
Men and women lose muscle mass and strength with age. Loss of muscle mass and strength is accompanied by a loss of muscle function which can lead to diminished quality of life and more importantly can lead to serious fall requiring medical treatment. The investigators hypothesize that the combined supplements of Calcium-HMB and Vitamin D will lead to decreased falls and to improved quality of life (QOL) for older adults. The investigators further hypothesize that the addition of a modest exercise regimen to these supplements will enhance the synergistic effects of both Calcium-HMB and Vitamin D.
Subjects will consume the dietary supplement 2 times per day for 12 months. Tests will consist of the following: a) strength of subjects' legs and elbow by Isokinetic Dynamometer; b) body composition; c) hand-grip strength by hand-grip dynamometer; d) functional mobility, balance and agility (Get-Up and Get-Up-and-Go tests); e) filling out questionnaires; and g) having blood drawn for biochemical measurements. Testing will be performed at the baseline (0 months) and at 3, 6, 9, and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo Exercise | Placebo comparator | Dietary Supplement: Placebo, Behavioral: ExercisePlacebo supplementation group with 3 days per week of exercise |
| Placebo Non-exercise | Placebo comparator | Dietary Supplement: Placebo, Behavioral: Non-ExercisePlacebo supplementation group without exercise |
| HMB plus Vitamin D Exercise | Active comparator | Drug: HMB plus Vitamin D, Behavioral: ExerciseHMB plus Vitamin D supplementation group with 3 days per week of exercise |
| HMB plus Vitamin D Non-exercise | Active comparator | Drug: HMB plus Vitamin D, Behavioral: Non-ExerciseHMB plus Vitamin D supplementation group without exercise |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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).
Key exclusion criteria (14 listed)
- 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.
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 |
|---|---|---|
| PlaceboA Placebo comparator | Dietary supplement | Placebo Exercise, Placebo Non-exercise |
| HMB plus Vitamin DAlso: HMB (Calcium beta-hydroxy-beta-methylbutyrate), Vitamin D (Cholecalciferol)Active comparator of HMB (3 g/d) plus Vitamin D (2,000 IU/d) | Drug | HMB plus Vitamin D Exercise, HMB plus Vitamin D Non-exercise |
| Non-ExerciseThis group will not participate in 3 times per week strength training | Behavioural | HMB plus Vitamin D Non-exercise, Placebo Non-exercise |
| ExerciseThis group will participate in a supervised 3 times per week strength training program | Behavioural | HMB plus Vitamin D Exercise, Placebo Exercise |
Primary outcome
Muscular strength
Time frame: 12 Months
Leg and elbow strength will be tested by Isokinetic dynamometer and Handgrip strength will be tested using a hand-grip dynamometer.
1 secondary outcome
Functionality
Time frame: 12 months
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 11 Feb 2019.
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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 HMB plus Vitamin D, Non-Exercise and Exercise in people with Sarcopenia, 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 12 inclusion and 14 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 11 Feb 2019. 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?
Muscular strength (time frame: 12 Months). 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 11 Feb 2019.