AgingNCT03848741
Independent and Combined Effects of Resistance Exercise Training and β-hydroxy β-methylbutyrate Plus Vitamin D
A study testing Resistance Exercise Training and HMB+VitD in people with Aging and Skeletal Muscle, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
During middle-age, humans begin to lose muscle mass and strength. With increasing age the deterioration of muscle health is associated with a decline in quality of life and the loss of independence. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aging, Skeletal Muscle
- What is being tested?
- Resistance Exercise Training and HMB+VitD
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to Apr 2021
- 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 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women between 45 and 60 years old
- Women with a BMI < 35 kg/m2
- Sedentary (< 30 minutes of structured physical activity 3 times per week)
- Weight stable for 3 months prior (+/- 5kg)
Who cannot join
- Body mass index > 35 kg/m2
- Type 1 or Type 2 diabetes
- Uncontrolled hypertension
- Active cancer, cancer in remission, or having received treatment for any form of cancer in the previous 5 years
- Cardiovascular disease (e.g., peripheral artery disease and peripheral vascular disease)
- Uncontrolled thyroid function
Show all 15Show fewer
- Chronic and/or regular consumption of medication known to influence skeletal muscle metabolism
- Use of Vitamin D (>2000 IU) or β-hydroxy β-methylbutyrate
- Tobacco use
- Any condition that limits exercise training (e.g., chronic obstructive pulmonary disease, neuromuscular disorder, moderate or severe cognitive impairment, Alzheimer's disease, vertigo, dizziness)
- High alcohol consumption defined as more than 8 drinks per week for women
- Unwilling to undergo any study-related procedures
- Pregnancy
- Abnormal liver or kidney enzymes determined in blood chemistry panel
- Bleeding/clotting disorders or blood thinning medications (e.g., warfarin, heparin)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Freer Hall
Urbana, Illinois, 61822
Adam Konopka, 217-300-5844, ark@illinois.edu
About this study
Official title: Independent and Combined Effects of Resistance Exercise Training and β-hydroxy β-methylbutyrate Plus Vitamin D on Body Composition and Skeletal Muscle Health
During middle-age, humans begin to lose muscle mass and strength. With increasing age the deterioration of muscle health is associated with a decline in quality of life and the loss of independence. β-hydroxy β-methylbutyrate (HMB) plus Vitamin D (VitD) have been proposed to increase skeletal muscle mass, contractile function and improve body composition but has yet to be evaluated in middle-aged women. The overall goal of this study is to determine the effects of HMB +VitD supplementation during 12 weeks of resistance exercise training or a non-exercise control on body composition, skeletal muscle size, and skeletal muscle function in middle-aged women.
Read the detailed description
To determine if HMB+VitD supplementation is an effective strategy to help prevent the loss of skeletal muscle size, skeletal muscle function and body composition in middle-aged women, forty eight women (45-60 yrs old) will be recruited to complete a 12-week intervention (n=12 per group; 4 groups). Participants will be randomized to complete a non-exercise control period or a resistance exercise training program. In a double-blinded fashion, participants in the non-exercise or resistance exercise groups will be randomized to consume either placebo or HMB+VitD. Before and after each intervention the investigators will evaluate skeletal muscle size, skeletal muscle function, and body composition.
- Conditions
- Aging, Skeletal Muscle
- Being tested
- Non-Exercise Control, Resistance Exercise Training, Placebo, HMB+VitD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Exercise ControlBehavioural
Participants will not perform structured exercise and will continue with their normal physical activity for 12-weeks.
Resistance Exercise TrainingBehavioural
Participants will complete a 12-week whole-body progressive resistance exercise training program.
PlaceboDietary supplement
Participants will be given placebo capsules to consume for 12-weeks.
HMB+VitDDietary supplement
Participants will be given HMB+VitD capsules to consume for 12-weeks
| Study group | Role | What they receive |
|---|---|---|
| Non-exercise control with placebo | Placebo comparator | Participants will be asked to maintain their normal physical activity and dietary habits during the 12-week intervention. Physical activity, diet, urine and blood samples will be collected every 4 weeks. Each participant will consume 3 placebo capsules (calcium lactate), twice a day with a meal or snack for a total of 6 capsules per day. Placebo capsules match the size, color, weight, and number of capsules per dose compared to the β-hydroxy β-methylbutyrate (HMB) Plus Vitamin D (VitD) capsules. Receives: Behavioral: Non-Exercise Control; Dietary Supplement: Placebo |
| Non-exercise control with HMB+VitD | Experimental | Participants will be asked to maintain their normal physical activity and dietary habits during the 12-week intervention. Physical activity, diet, urine and blood samples will be collected every 4 weeks. Each participant will consume 3 HMB+VitD capsules, twice a day with a meal or snack for a total of 6 capsules per day. Each capsule contains 500 mg calcium HMB and 333.33 IU Vitamin D for a total of 3.0 g HMB and 2000 IU Vitamin D per day. Receives: Behavioral: Non-Exercise Control; Dietary Supplement: HMB+VitD |
| Resistance exercise training with placebo | Active comparator | Participants will complete 12-weeks (3 days per week) of a whole-body progressive resistance exercise training program. Physical activity, diet, urine and blood samples will be collected every 4 weeks. Each participant will consume 3 placebo capsules (calcium lactate), twice a day with a meal or snack for a total of 6 capsules per day. Participants will be asked to take capsules ~30-60 minutes before resistance exercise. Placebo capsules match the size, color, weight, and number of capsules per dose compared to the HMB + VitD capsules. Receives: Behavioral: Resistance Exercise Training; Dietary Supplement: Placebo |
| Resistance exercise training with HMB+VitD | Experimental | Participants will complete 12-weeks (3 days per week) of a whole-body progressive resistance exercise training program. Physical activity, diet, urine and blood samples will be collected every 4 weeks. Each participant will consume 3 HMB+VitD capsules, twice a day with a meal or snack for a total of 6 capsules per day. Participants will be asked to take capsules ~30-60 minutes before resistance exercise. Each capsule contains 500 mg calcium HMB and 333.33 IU Vitamin D for a total of 3.0 g HMB and 2000 IU Vitamin D per day. Receives: Behavioral: Resistance Exercise Training; Dietary Supplement: HMB+VitD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal Muscle Function - Knee extensor isometric performance
Knee extensor isometric performance will be assessed by a dynamometer. Muscle strength will also be determined by 1 repetition maximum for leg extension, leg curl and leg press exercises.
Measured: Change from baseline to after the 12 week intervention
Skeletal Muscle Function - Knee extensor isokinetic performance
Knee extensor isokinetic performance will be assessed by a dynamometer.
Measured: Change from baseline to after the 12 week intervention
Skeletal Muscle Function - Fatigue
Knee extensor fatigue will be assessed by a dynamometer.
Measured: Change from baseline to after the 12 week intervention
Skeletal Muscle Cross Sectional Area
Skeletal muscle cross sectional area will be assessed via magnetic resonance imaging (MRI).
Measured: Change from baseline to after the 12 week intervention
Skeletal Muscle Volume
Skeletal muscle volume will be assessed via magnetic resonance imaging (MRI).
Measured: Change from baseline to after the 12 week intervention
Body Composition - Mass
Fat and fat free mass will be measured using by a dual x-ray absorptiometry (DEXA) scan.
Measured: Change from baseline to after the 12 week intervention
Body Composition - Percentage
Fat and fat free percent will be measured using by a dual x-ray absorptiometry (DEXA) scan.
Measured: Change from baseline to after the 12 week intervention
Skeletal Muscle Mitochondrial Respiration
Mitochondrial respiration will be assessed using high-resolution respirometry in permeabilized muscle fibers.
Measured: Change from baseline to after the 12 week intervention
Skeletal Muscle Mitochondrial Hydrogen Peroxide Emissions
Mitochondrial hydrogen peroxide emissions will be assessed using high-resolution fluorometry in permeabilized muscle fibers.
Measured: Change from baseline to after the 12 week intervention
Myofiber Size
Cross sectional area of muscle fibers will be evaluated with immunohistochemistry.
Measured: Change from baseline to after the 12 week intervention
Secondary outcomes (1)
Bone Density
Bone mineral density will be evaluated by a dual x-ray absorptiometry (DEXA) scan.
Measured: Change from baseline to after the 12 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start1 Apr 2019
- Primary completionDec 2020 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Model description
- Participants will be randomized to 1 of 4, 12-week interventions. In a double-blinded fashion, participants will be randomized to consume either placebo or HMB + VitD supplementation. Group 1 will serve as a non-exercise control with placebo; Group 2 will serve as a non-exercise control with β-hydroxy β-methylbutyrate + Vitamin D; Group 3 will complete resistance exercise training with placebo; Group 4 will complete resistance exercise training with β-hydroxy β-methylbutyrate + Vitamin D
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- Metabolic Technologies Inc.
- Responsible party
- Principal investigator, Adam Konopka, University of Illinois at Urbana-Champaign
- Investigators
- Adam Konopka, PhD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848741
- Sponsor's protocol ID
- 093635
- Status last verified
- Jul 2019
- First submitted
- 18 Feb 2019
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Independent and Combined Effects of Resistance Exercise Training and β-hydroxy β-methylbutyrate Plus Vitamin D on Body Composition and Skeletal Muscle Health
- ClinicalTrials.gov ID
- NCT03848741
- Acronym / sponsor ID
- 093635
- Conditions
- Aging, Skeletal Muscle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- Metabolic Technologies Inc.
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 21 Feb 2019 (actual)
- 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.
During middle-age, humans begin to lose muscle mass and strength. With increasing age the deterioration of muscle health is associated with a decline in quality of life and the loss of independence. β-hydroxy β-methylbutyrate (HMB) plus Vitamin D (VitD) have been proposed to increase skeletal muscle mass, contractile function and improve body composition but has yet to be evaluated in middle-aged women. The overall goal of this study is to determine the effects of HMB +VitD supplementation during 12 weeks of resistance exercise training or a non-exercise control on body composition, skeletal muscle size, and skeletal muscle function in middle-aged women.
Detailed description
To determine if HMB+VitD supplementation is an effective strategy to help prevent the loss of skeletal muscle size, skeletal muscle function and body composition in middle-aged women, forty eight women (45-60 yrs old) will be recruited to complete a 12-week intervention (n=12 per group; 4 groups). Participants will be randomized to complete a non-exercise control period or a resistance exercise training program. In a double-blinded fashion, participants in the non-exercise or resistance exercise groups will be randomized to consume either placebo or HMB+VitD. Before and after each intervention the investigators will evaluate skeletal muscle size, skeletal muscle function, and body composition.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants will be randomized to 1 of 4, 12-week interventions. In a double-blinded fashion, participants will be randomized to consume either placebo or HMB + VitD supplementation. Group 1 will serve as a non-exercise control with placebo; Group 2 will serve as a non-exercise control with β-hydroxy β-methylbutyrate + Vitamin D; Group 3 will complete resistance exercise training with placebo; Group 4 will complete resistance exercise training with β-hydroxy β-methylbutyrate + Vitamin D
| Arm | Type | Receives |
|---|---|---|
| Non-exercise control with placebo | Placebo comparator | Behavioral: Non-Exercise Control, Dietary Supplement: PlaceboParticipants will be asked to maintain their normal physical activity and dietary habits during the 12-week intervention. Physical activity, diet, urine and blood samples will be collected every 4 weeks. Each participant will consume 3 placebo capsules (calcium lactate), twice a day with a meal or snack for a total of 6 capsules per day. Placebo capsules match the size, color, weight, and number of capsules per dose compared to the β-hydroxy β-methylbutyrate (HMB) Plus Vitamin D (VitD) capsules. |
| Non-exercise control with HMB+VitD | Experimental | Behavioral: Non-Exercise Control, Dietary Supplement: HMB+VitDParticipants will be asked to maintain their normal physical activity and dietary habits during the 12-week intervention. Physical activity, diet, urine and blood samples will be collected every 4 weeks. Each participant will consume 3 HMB+VitD capsules, twice a day with a meal or snack for a total of 6 capsules per day. Each capsule contains 500 mg calcium HMB and 333.33 IU Vitamin D for a total of 3.0 g HMB and 2000 IU Vitamin D per day. |
| Resistance exercise training with placebo | Active comparator | Behavioral: Resistance Exercise Training, Dietary Supplement: PlaceboParticipants will complete 12-weeks (3 days per week) of a whole-body progressive resistance exercise training program. Physical activity, diet, urine and blood samples will be collected every 4 weeks. Each participant will consume 3 placebo capsules (calcium lactate), twice a day with a meal or snack for a total of 6 capsules per day. Participants will be asked to take capsules ~30-60 minutes before resistance exercise. Placebo capsules match the size, color, weight, and number of capsules per dose compared to the HMB + VitD capsules. |
| Resistance exercise training with HMB+VitD | Experimental | Behavioral: Resistance Exercise Training, Dietary Supplement: HMB+VitDParticipants will complete 12-weeks (3 days per week) of a whole-body progressive resistance exercise training program. Physical activity, diet, urine and blood samples will be collected every 4 weeks. Each participant will consume 3 HMB+VitD capsules, twice a day with a meal or snack for a total of 6 capsules per day. Participants will be asked to take capsules ~30-60 minutes before resistance exercise. Each capsule contains 500 mg calcium HMB and 333.33 IU Vitamin D for a total of 3.0 g HMB and 2000 IU Vitamin D per day. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women between 45 and 60 years old
- Women with a BMI < 35 kg/m2
- Sedentary (< 30 minutes of structured physical activity 3 times per week)
- Weight stable for 3 months prior (+/- 5kg)
Key exclusion criteria (15 listed)
- Body mass index > 35 kg/m2
- Type 1 or Type 2 diabetes
- Uncontrolled hypertension
- Active cancer, cancer in remission, or having received treatment for any form of cancer in the previous 5 years
- Cardiovascular disease (e.g., peripheral artery disease and peripheral vascular disease)
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 |
|---|---|---|
| Non-Exercise ControlParticipants will not perform structured exercise and will continue with their normal physical activity for 12-weeks. | Behavioural | Non-exercise control with HMB+VitD, Non-exercise control with placebo |
| Resistance Exercise TrainingParticipants will complete a 12-week whole-body progressive resistance exercise training program. | Behavioural | Resistance exercise training with HMB+VitD, Resistance exercise training with placebo |
| PlaceboParticipants will be given placebo capsules to consume for 12-weeks. | Dietary supplement | Non-exercise control with placebo, Resistance exercise training with placebo |
| HMB+VitDParticipants will be given HMB+VitD capsules to consume for 12-weeks | Dietary supplement | Non-exercise control with HMB+VitD, Resistance exercise training with HMB+VitD |
Primary outcome
Skeletal Muscle Function - Knee extensor isometric performance
Time frame: Change from baseline to after the 12 week intervention
Knee extensor isometric performance will be assessed by a dynamometer. Muscle strength will also be determined by 1 repetition maximum for leg extension, leg curl and leg press exercises.
Skeletal Muscle Function - Knee extensor isokinetic performance
Time frame: Change from baseline to after the 12 week intervention
Knee extensor isokinetic performance will be assessed by a dynamometer.
Skeletal Muscle Function - Fatigue
Time frame: Change from baseline to after the 12 week intervention
Knee extensor fatigue will be assessed by a dynamometer.
Skeletal Muscle Cross Sectional Area
Time frame: Change from baseline to after the 12 week intervention
Skeletal muscle cross sectional area will be assessed via magnetic resonance imaging (MRI).
Skeletal Muscle Volume
Time frame: Change from baseline to after the 12 week intervention
Skeletal muscle volume will be assessed via magnetic resonance imaging (MRI).
Body Composition - Mass
Time frame: Change from baseline to after the 12 week intervention
Fat and fat free mass will be measured using by a dual x-ray absorptiometry (DEXA) scan.
Body Composition - Percentage
Time frame: Change from baseline to after the 12 week intervention
Fat and fat free percent will be measured using by a dual x-ray absorptiometry (DEXA) scan.
Skeletal Muscle Mitochondrial Respiration
Time frame: Change from baseline to after the 12 week intervention
Mitochondrial respiration will be assessed using high-resolution respirometry in permeabilized muscle fibers.
Skeletal Muscle Mitochondrial Hydrogen Peroxide Emissions
Time frame: Change from baseline to after the 12 week intervention
Mitochondrial hydrogen peroxide emissions will be assessed using high-resolution fluorometry in permeabilized muscle fibers.
Myofiber Size
Time frame: Change from baseline to after the 12 week intervention
Cross sectional area of muscle fibers will be evaluated with immunohistochemistry.
1 secondary outcome
Bone Density
Time frame: Change from baseline to after the 12 week intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Adam Konopka, PhD principal investigator
University of Illinois at Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Exercise Training and HMB+VitD in people with Aging and Skeletal Muscle, run by University of Illinois at Urbana-Champaign 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 4 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 17 Jul 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adam Konopka, PhD (1 217 300 5844, ark@illinois.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal Muscle Function - Knee extensor isometric performance (time frame: Change from baseline to after the 12 week intervention). The study lists 10 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 17 Jul 2019.