ObesityNCT02717013
The Effect of HMB Supplementation on Adipose Tissue Inflammation and Metabolism
A study testing HMB in people with Obesity, run by Metabolic Technologies Inc. at 1 site in United States.
Trial summary
This study will determine the effects of supplementing beta-hydroxy-beta-methylbutyrate (HMB) on body composition and strength changes during weight loss. When overweight and obese persons lose weight, and in particular in conjunction with dietary restrictions, muscle, bone mass, and muscle strength are also lost. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- HMB
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Feb 2017
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Non-smoker
- Body mass index of 35-40 kg/m2
- Age 18-40 years
- Weight stable for past 6 months (<5 lb. change)
- In good health, free of chronic diseases/conditions that may impact measured outcomes
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- Willing and able to consume a weight loss diet
- Willing and able to consume a daily nutritional supplement (in pill form)
- Available for scheduled study commitments during the 2 months of study
Who cannot join
- Smoke
- Take any cholesterol lowering or weight loss drugs or an drugs or supplements that affect blood lipids, insulin or body composition
- Weigh greater 300 pounds due to weight, size and depth limitations of equipment
- Take dietary supplements
- Have a chronic disease such as:
- Cardiopulmonary disease (e.g. recent myocardial infarction, unstable angina, stroke) or unstable disease
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- Severe orthopedic/musculoskeletal or neuromuscular impairments that would contradict exercise
- Sensory impairments that interfere with following directions
- Diagnosis if dementia
- History of malignancy during the past 5 years
- Diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
This study will determine the effects of supplementing beta-hydroxy-beta-methylbutyrate (HMB) on body composition and strength changes during weight loss. When overweight and obese persons lose weight, and in particular in conjunction with dietary restrictions, muscle, bone mass, and muscle strength are also lost. HMB has been shown to preserve muscle mass and strength, and it is thought that HMB may also preserve muscle, bone, and strength during weight-loss.
Read the detailed description
Forty obese men (BMI 35-40 kg/m2,18-40 years of age) will be randomly assigned to one of four treatment interventions: 1) Calorie restricted; 2) Calorie restricted and HMB supplemented; 3) No calorie restriction; and 4) No calorie restriction and HMB-supplemented. Over the 8 week interventional period the calorie restricted group is expected to lose 3-5% of initial body weight. Anthropometric measures will be taken weekly, and dual energy x-ray absorptiometry (DXA) body composition and strength will be measured before and after 8-weeks of intervention. Blood and urine will be collected and analyzed at 0, 4, and 8 weeks. Additionally Dietary records and questionnaires concerning quality of life will be administered, and activity will be assessed using questionnaires and pedometers. Muscle biopsies will be taken before and after the 8-week study.
- Conditions
- Obesity
- Being tested
- Placebo, HMB
- Keywords
- Muscle, Bone, Fat
- Medical subject headings
- Obesity, Platelet Glycoprotein IV Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Placebo capsules containing calcium lactate similar to the HMB capsules.
HMBDietary supplement
HMB capsules supplying 3 grams per day of calcium beta-hydroxyl-beta-methylbutyrate.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Diet Restriction | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Placebo No Diet Restriction | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| HMB Diet Restriction | Active comparator | Not described Receives: Dietary Supplement: HMB |
| HMB No Diet Restriction | Active comparator | Not described Receives: Dietary Supplement: HMB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance of bone mineral density
Bone mineral density measured by DXA (T-score)
Measured: 8 weeks
Maintenance of lean mass
Lean Mass measured by DXA (kg)
Measured: 8 weeks
Maintenance of muscle strength
Muscle strength will be assessed using a Biodex Isokinetic Dynamometer (N-m)
Measured: 8 weeks
Maintenance of hand muscle strength
Hand muscle strength will be assessed using hand grips (kg)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Why it stopped: Lack of recruitment of subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metabolic Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Iowa State University
- Responsible party
- Sponsor
- Investigators
- Rudy Valentine, PhD, Principal investigator, Iowa State UniversityJohn A Rathmacher, PhD, Principal investigator, Metabolic Technologies Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717013
- Sponsor's protocol ID
- MTI2016-CS01
- Status last verified
- Feb 2017
- First submitted
- 11 Mar 2016
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No Individual Data will be shared. Data summaries will be available after publication..
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of HMB Supplementation on Adipose Tissue Inflammation and Metabolism
- ClinicalTrials.gov ID
- NCT02717013
- Acronym / sponsor ID
- MTI2016-CS01
- Conditions
- Obesity
- Keywords
- Muscle, Bone, Fat
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment of subjects.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Metabolic Technologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- Iowa State University
- Study start
- Mar 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 23 Mar 2016 (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.
This study will determine the effects of supplementing beta-hydroxy-beta-methylbutyrate (HMB) on body composition and strength changes during weight loss. When overweight and obese persons lose weight, and in particular in conjunction with dietary restrictions, muscle, bone mass, and muscle strength are also lost. HMB has been shown to preserve muscle mass and strength, and it is thought that HMB may also preserve muscle, bone, and strength during weight-loss.
Detailed description
Forty obese men (BMI 35-40 kg/m2,18-40 years of age) will be randomly assigned to one of four treatment interventions: 1) Calorie restricted; 2) Calorie restricted and HMB supplemented; 3) No calorie restriction; and 4) No calorie restriction and HMB-supplemented. Over the 8 week interventional period the calorie restricted group is expected to lose 3-5% of initial body weight. Anthropometric measures will be taken weekly, and dual energy x-ray absorptiometry (DXA) body composition and strength will be measured before and after 8-weeks of intervention. Blood and urine will be collected and analyzed at 0, 4, and 8 weeks. Additionally Dietary records and questionnaires concerning quality of life will be administered, and activity will be assessed using questionnaires and pedometers. Muscle biopsies will be taken before and after the 8-week study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo Diet Restriction | Placebo comparator | Dietary Supplement: Placebo |
| Placebo No Diet Restriction | Placebo comparator | Dietary Supplement: Placebo |
| HMB Diet Restriction | Active comparator | Dietary Supplement: HMB |
| HMB No Diet Restriction | Active comparator | Dietary Supplement: HMB |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male
- Non-smoker
- Body mass index of 35-40 kg/m2
- Age 18-40 years
- Weight stable for past 6 months (<5 lb. change)
Key exclusion criteria (11 listed)
- Smoke
- Take any cholesterol lowering or weight loss drugs or an drugs or supplements that affect blood lipids, insulin or body composition
- Weigh greater 300 pounds due to weight, size and depth limitations of equipment
- Take dietary supplements
- Have a chronic disease such as:
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 |
|---|---|---|
| PlaceboPlacebo capsules containing calcium lactate similar to the HMB capsules. | Dietary supplement | Placebo Diet Restriction, Placebo No Diet Restriction |
| HMBHMB capsules supplying 3 grams per day of calcium beta-hydroxyl-beta-methylbutyrate. | Dietary supplement | HMB Diet Restriction, HMB No Diet Restriction |
Primary outcome
Maintenance of bone mineral density
Time frame: 8 weeks
Bone mineral density measured by DXA (T-score)
Maintenance of lean mass
Time frame: 8 weeks
Lean Mass measured by DXA (kg)
Maintenance of muscle strength
Time frame: 8 weeks
Muscle strength will be assessed using a Biodex Isokinetic Dynamometer (N-m)
Maintenance of hand muscle strength
Time frame: 8 weeks
Hand muscle strength will be assessed using hand grips (kg)
Results and safety
The study was stopped early (reason given: Lack of recruitment of subjects.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Individual participant dataSharing planned: No. No Individual Data will be shared. Data summaries will be available after publication..
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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.
Rudy Valentine, PhD principal investigator
Iowa State University
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 HMB in people with Obesity, 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 11 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: stopped early, as of the sponsor's last update on 3 Mar 2017. 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 was stopped early (reason given: Lack of recruitment of subjects.). Results are not available in the source record.
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?
Maintenance of bone mineral density (time frame: 8 weeks). The study lists 4 primary outcomes in all. 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 3 Mar 2017.