Aging WellNCT04734951
Muscle Quality Index Improvement by Exercise and HMB Oral Supplementation in Older Adults
A study testing Power/resistance exercise program and HMB supplementation in people with Aging Well, run by Instituto Nacional de Rehabilitacion.
Trial summary
The aging process is accompanied by a decrease in several biological and physical functions, which have an impact on the perception of well-being and quality of life. Among these, the decrease in muscle mass, strength and power are of particular importance as they are associated with poor cardiorespiratory function… Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Aging Well
- What is being tested?
- Power/resistance exercise program and HMB supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- Jun 2023to Aug 2024
- 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 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Body mass index 25-30 km/m^2
- Appendicular skeletal muscle mass index in women ≥ 5.0 kg/m^2 and men ≥ 6.0 kg/m^2
- No regular exercise
- Non-smokers
- Compensated comorbidities
- Without consumption of nutritional supplements
Who cannot join
- Osteoporosis
- Cardiovascular diseases (recent heart attack, unstable angina, heart failure, complete atrioventricular block)
- Musculoskeletal injuries
- Severe cognitive impairment
- Major depressive disorder
- Thyroid diseases
Show all 14Show fewer
- Anemia with no response to previous treatment in the last 3 months
- b2-adrenergic agonists, glucocorticoids, diuretics or peripheral vasodilators users
- With amino acid and vitamin D supplementation or suspended with less than 3 months
- Data of renal insufficiency
- Chronic obstructive pulmonary disease
- Malabsorption syndrome associated with malnutrition
- High risk of falls evaluated with the Tinetti scale (score ≤19)
- Frailty syndrome
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of a Power/Resistance Exercise Program and Oral Supplementation With Beta-hydroxy-beta-methyl Butyrate (HMB) on the Muscle Quality Index in Older Adults. A Randomized Controlled Trial
The aging process is accompanied by a decrease in several biological and physical functions, which have an impact on the perception of well-being and quality of life. Among these, the decrease in muscle mass, strength and power are of particular importance as they are associated with poor cardiorespiratory function, functional limitations and mortality. The muscle quality index (MQI) is considered a key determinant of muscle function in adulthood. The main treatment to preserve muscle mass has been strength exercise and in some cases the use of aids that influence protein metabolism such as beta-hydroxy-beta-methyl butyrate (HMB), but the evidence on this topic is not consistent and is inconclusive. Therefore, the main purpose of this study is to investigate if the combination of a power/resistance exercise program and oral supplementation with HMB can improve the quality mass index in adults aged compared with those received a single exercise program after 14 weeks of intervention.
Read the detailed description
Study design: this is a 14-week, randomized controlled trial. 76 participants will be recruited from the medical services of the National Institute of Rehabilitation (NIR).
Participants: Adults between 65-75 years old, with a body mass index between 25-30 kg/m^2, sedentaries, non-smokers, with compensated comorbidities, and who do not consume nutritional supplements will be recruited. Participants with uncompensated metabolic diseases, with high risk of falls (evaluated with Tinetti scale), frailty syndrome, and b2-adrenergic agonists, glucocorticoids, diuretics or peripheral vasodilators users will not be recruited.
Intervention: Participants will be randomized to 1) power/resistance exercise program (GEx), 2) power/resistance exercise program + HMB group (GExHMB) with computer-generated random numbers. The exercise program will consist of training to improve muscular strength, neuromotor skills, flexibility, endurance, and a greater emphasis on maximum strength and power. Every training session will consist of 15 minutes of warm-up, 40 to 60 minutes of power/resistance training, neuromuscular and aerobic exercises, and 15 minutes of cool-down. The power/resistance and neuromuscular training will be performed 3 days/week, 2-5 sets, 5-15 repetitions for each exercise according to the recommendation of the American College of Sports Medicine training progression models; the aerobic exercise will be performed 2 days/week. All exercises will be performed at moderate intensity and will take place in the NIR Sports Medicine therapeutic gym.
Oral supplementation with HMB will be from a commercial polymeric formula in liquid form (Ensure Advanced®, 230 ml); the supplement intake will be 1 bottle/day. All patients, regardless of the intervention, will be monitored by sports medicine physicians and nutritionists in order to promote adherence to treatment.
The muscle quality index (MQI) will be obtained from the determination of muscular strength by isokinetic dynamometry (at 60°/s) for the lower extremities and by hand dynamometry for the upper extremities; the lean segmental mass in the upper and lower extremities will be determined by 3-frequency electronic bioimpedance analysis. The MQI will be calculated from the muscular strength divided by the muscular mass.
Lower extremities muscular power will be determined by isokinetic dynamometry at 180°/s, physical performance will be assessed by the Short Physical Performance battery (SPPB) and quality of life perception will be evaluated by the EuroQoL-5D questionnaire. As part of the safety measures for the participants, liver function will be monitored by laboratory tests (liver enzyme profile and general urine test) which will be performed at the NIR laboratory.
For each participant the study length will be 14 weeks with 61 exercise sessions for the GEx and GExHMB groups and 98 days of oral supplementation for the GExHMB group. The beginning of the study corresponds to session 1 of exercise and day 1 of supplementation intake. Initial evaluations will be performed 5 days prior to the start of the intervention, while final evaluations will be conducted at the end of 14 weeks of follow-up (2 days after the last day of the intervention). Data will be recorded by study investigators blinded to participant assignment.
Comparison: Comparison group will receive the unique intervention of a strength/resistance exercise program.
Outcomes: The primary outcome is the upper and lower extremities MQI mean change. The secondary outcomes are mean changes in muscular power, physical performance, and health related quality of life.
- Conditions
- Aging Well
- Being tested
- Power/resistance exercise program, HMB supplementation
- Keywords
- Older Adults, Muscle quality index, Exercise training, HMB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Power/resistance exercise programOther
participants will complete a power/resistance program during 14 weeks. The exercise program will consist of training to improve muscle strength, neuromotor skills, flexibility, endurance, and a greater emphasis on maximum strength and power. The intensity will be set according the estimated repetition to failure.
HMB supplementationDietary supplement
Daily oral supplementation with 237 ml of a polymeric nutritional formula added with 1.5 g of HMB (Ensure Advance®)
| Study group | Role | What they receive |
|---|---|---|
| Power/resistance exercise | Active comparator | Participants on a power/resistance exercise program Receives: Other: Power/resistance exercise program |
| Power/resistance exercise + HMB | Experimental | Participants on combined power/resistance exercise program + HMB oral supplementation Receives: Other: Power/resistance exercise program; Dietary Supplement: HMB supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline arm Muscle Quality Index (MQIarm)
The muscle quality index from dominant arm will be calculated with data obtained from hand grip strength, and lean mass obtained by bioimpedance analysis according with the formula:
MQIarm = hand grip strength (kg) / arm lean mass (kg)
Measured: Baseline and 14 weeks
Mean change from baseline leg Muscle Quality Index (MQIleg)
The muscle quality index from dominant leg will be calculated with data obtained by isokinetic, and lean mass obtained by bioimpedance analysis according with the formula:
MQIleg = peak torque (Nm) / leg lean mass (kg)
Measured: Baseline and 14 weeks
Secondary outcomes (3)
Mean change from baseline muscular power
The muscular power will be determined by isokinetic dynamometry at 180°/s
Measured: Baseline and 14 weeks
Short Physical Performance Battery (SPPB)
Short Physical Performance Battery scale, range 0-12. The higher the score, the better the physical performance
Measured: Baseline and 14 weeks
Health-related quality of life
EuroQol-5D (5 dimension) scale; the lower the level (1-3), the better the health state
Measured: Baseline and 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study startJun 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Aging WellStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Rehabilitacion
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ariadna del Villar Morales, Instituto Nacional de Rehabilitacion
- Investigators
- Ariadna d Morales, MD, Principal investigator, National Institute of Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734951
- Sponsor's protocol ID
- 34/20
- Status last verified
- Mar 2023
- First submitted
- 14 Dec 2020
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fragala MS, Kenny AM, Kuchel GA. Muscle quality in aging: a multi-dimensional approach to muscle functioning with applications for treatment. Sports Med. 2015 May;45(5):641-58. doi: 10.1007/s40279-015-0305-z.
PubMed 25655372Barbieri E, Agostini D, Polidori E, Potenza L, Guescini M, Lucertini F, Annibalini G, Stocchi L, De Santi M, Stocchi V. The pleiotropic effect of physical exercise on mitochondrial dynamics in aging skeletal muscle. Oxid Med Cell Longev. 2015;2015:917085. doi: 10.1155/2015/917085. Epub 2015 Apr 5.
PubMed 25945152Barbat-Artigas S, Rolland Y, Zamboni M, Aubertin-Leheudre M. How to assess functional status: a new muscle quality index. J Nutr Health Aging. 2012 Jan;16(1):67-77. doi: 10.1007/s12603-012-0004-5.
PubMed 22238004Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
PubMed 30312372Stout JR, Smith-Ryan AE, Fukuda DH, Kendall KL, Moon JR, Hoffman JR, Wilson JM, Oliver JS, Mustad VA. Effect of calcium beta-hydroxy-beta-methylbutyrate (CaHMB) with and without resistance training in men and women 65+yrs: a randomized, double-blind pilot trial. Exp Gerontol. 2013 Nov;48(11):1303-10. doi: 10.1016/j.exger.2013.08.007. Epub 2013 Aug 24.
PubMed 23981904Cooper R, Hardy R, Bann D, Aihie Sayer A, Ward KA, Adams JE, Kuh D; MRC National Survey of Health and Development Scientific and Data Collection Team. Body mass index from age 15 years onwards and muscle mass, strength, and quality in early old age: findings from the MRC National Survey of Health and Development. J Gerontol A Biol Sci Med Sci. 2014 Oct;69(10):1253-9. doi: 10.1093/gerona/glu039. Epub 2014 Mar 28.
PubMed 24682351Holecek M. Beta-hydroxy-beta-methylbutyrate supplementation and skeletal muscle in healthy and muscle-wasting conditions. J Cachexia Sarcopenia Muscle. 2017 Aug;8(4):529-541. doi: 10.1002/jcsm.12208. Epub 2017 May 10.
PubMed 28493406He X, Duan Y, Yao K, Li F, Hou Y, Wu G, Yin Y. beta-Hydroxy-beta-methylbutyrate, mitochondrial biogenesis, and skeletal muscle health. Amino Acids. 2016 Mar;48(3):653-664. doi: 10.1007/s00726-015-2126-7. Epub 2015 Nov 14.
PubMed 26573541Barry BK, Carson RG. The consequences of resistance training for movement control in older adults. J Gerontol A Biol Sci Med Sci. 2004 Jul;59(7):730-54. doi: 10.1093/gerona/59.7.m730.
PubMed 15304540Liu CJ, Latham NK. Progressive resistance strength training for improving physical function in older adults. Cochrane Database Syst Rev. 2009 Jul 8;2009(3):CD002759. doi: 10.1002/14651858.CD002759.pub2.
PubMed 19588334Wandrag L, Brett SJ, Frost G, Hickson M. Impact of supplementation with amino acids or their metabolites on muscle wasting in patients with critical illness or other muscle wasting illness: a systematic review. J Hum Nutr Diet. 2015 Aug;28(4):313-30. doi: 10.1111/jhn.12238. Epub 2014 May 8.
PubMed 24807079Morton RW, Murphy KT, McKellar SR, Schoenfeld BJ, Henselmans M, Helms E, Aragon AA, Devries MC, Banfield L, Krieger JW, Phillips SM. A systematic review, meta-analysis and meta-regression of the effect of protein supplementation on resistance training-induced gains in muscle mass and strength in healthy adults. Br J Sports Med. 2018 Mar;52(6):376-384. doi: 10.1136/bjsports-2017-097608. Epub 2017 Jul 11.
PubMed 28698222Bear DE, Langan A, Dimidi E, Wandrag L, Harridge SDR, Hart N, Connolly B, Whelan K. beta-Hydroxy-beta-methylbutyrate and its impact on skeletal muscle mass and physical function in clinical practice: a systematic review and meta-analysis. Am J Clin Nutr. 2019 Apr 1;109(4):1119-1132. doi: 10.1093/ajcn/nqy373.
PubMed 30982854Vukovich MD, Stubbs NB, Bohlken RM. Body composition in 70-year-old adults responds to dietary beta-hydroxy-beta-methylbutyrate similarly to that of young adults. J Nutr. 2001 Jul;131(7):2049-52. doi: 10.1093/jn/131.7.2049.
PubMed 11435528Courel-Ibanez J, Vetrovsky T, Dadova K, Pallares JG, Steffl M. Health Benefits of beta-Hydroxy-beta-Methylbutyrate (HMB) Supplementation in Addition to Physical Exercise in Older Adults: A Systematic Review with Meta-Analysis. Nutrients. 2019 Sep 3;11(9):2082. doi: 10.3390/nu11092082.
PubMed 31484462
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Power/Resistance Exercise Program and Oral Supplementation With Beta-hydroxy-beta-methyl Butyrate (HMB) on the Muscle Quality Index in Older Adults. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04734951
- Acronym / sponsor ID
- 34/20
- Conditions
- Aging Well
- Keywords
- Older Adults, Muscle quality index, Exercise training, HMB
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Instituto Nacional de RehabilitacionOther government
- Study start
- Jun 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 2 Feb 2021 (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.
The aging process is accompanied by a decrease in several biological and physical functions, which have an impact on the perception of well-being and quality of life. Among these, the decrease in muscle mass, strength and power are of particular importance as they are associated with poor cardiorespiratory function, functional limitations and mortality. The muscle quality index (MQI) is considered a key determinant of muscle function in adulthood. The main treatment to preserve muscle mass has been strength exercise and in some cases the use of aids that influence protein metabolism such as beta-hydroxy-beta-methyl butyrate (HMB), but the evidence on this topic is not consistent and is inconclusive. Therefore, the main purpose of this study is to investigate if the combination of a power/resistance exercise program and oral supplementation with HMB can improve the quality mass index in adults aged compared with those received a single exercise program after 14 weeks of intervention.
Detailed description
Study design: this is a 14-week, randomized controlled trial. 76 participants will be recruited from the medical services of the National Institute of Rehabilitation (NIR).
Participants: Adults between 65-75 years old, with a body mass index between 25-30 kg/m^2, sedentaries, non-smokers, with compensated comorbidities, and who do not consume nutritional supplements will be recruited. Participants with uncompensated metabolic diseases, with high risk of falls (evaluated with Tinetti scale), frailty syndrome, and b2-adrenergic agonists, glucocorticoids, diuretics or peripheral vasodilators users will not be recruited.
Intervention: Participants will be randomized to 1) power/resistance exercise program (GEx), 2) power/resistance exercise program + HMB group (GExHMB) with computer-generated random numbers. The exercise program will consist of training to improve muscular strength, neuromotor skills, flexibility, endurance, and a greater emphasis on maximum strength and power. Every training session will consist of 15 minutes of warm-up, 40 to 60 minutes of power/resistance training, neuromuscular and aerobic exercises, and 15 minutes of cool-down. The power/resistance and neuromuscular training will be performed 3 days/week, 2-5 sets, 5-15 repetitions for each exercise according to the recommendation of the American College of Sports Medicine training progression models; the aerobic exercise will be performed 2 days/week. All exercises will be performed at moderate intensity and will take place in the NIR Sports Medicine therapeutic gym.
Oral supplementation with HMB will be from a commercial polymeric formula in liquid form (Ensure Advanced®, 230 ml); the supplement intake will be 1 bottle/day. All patients, regardless of the intervention, will be monitored by sports medicine physicians and nutritionists in order to promote adherence to treatment.
The muscle quality index (MQI) will be obtained from the determination of muscular strength by isokinetic dynamometry (at 60°/s) for the lower extremities and by hand dynamometry for the upper extremities; the lean segmental mass in the upper and lower extremities will be determined by 3-frequency electronic bioimpedance analysis. The MQI will be calculated from the muscular strength divided by the muscular mass.
Lower extremities muscular power will be determined by isokinetic dynamometry at 180°/s, physical performance will be assessed by the Short Physical Performance battery (SPPB) and quality of life perception will be evaluated by the EuroQoL-5D questionnaire. As part of the safety measures for the participants, liver function will be monitored by laboratory tests (liver enzyme profile and general urine test) which will be performed at the NIR laboratory.
For each participant the study length will be 14 weeks with 61 exercise sessions for the GEx and GExHMB groups and 98 days of oral supplementation for the GExHMB group. The beginning of the study corresponds to session 1 of exercise and day 1 of supplementation intake. Initial evaluations will be performed 5 days prior to the start of the intervention, while final evaluations will be conducted at the end of 14 weeks of follow-up (2 days after the last day of the intervention). Data will be recorded by study investigators blinded to participant assignment.
Comparison: Comparison group will receive the unique intervention of a strength/resistance exercise program.
Outcomes: The primary outcome is the upper and lower extremities MQI mean change. The secondary outcomes are mean changes in muscular power, physical performance, and health related quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Power/resistance exercise | Active comparator | Other: Power/resistance exercise programParticipants on a power/resistance exercise program |
| Power/resistance exercise + HMB | Experimental | Other: Power/resistance exercise program, Dietary Supplement: HMB supplementationParticipants on combined power/resistance exercise program + HMB oral supplementation |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Body mass index 25-30 km/m^2
- Appendicular skeletal muscle mass index in women ≥ 5.0 kg/m^2 and men ≥ 6.0 kg/m^2
- No regular exercise
- Non-smokers
- Compensated comorbidities
Key exclusion criteria (14 listed)
- Osteoporosis
- Cardiovascular diseases (recent heart attack, unstable angina, heart failure, complete atrioventricular block)
- Musculoskeletal injuries
- Severe cognitive impairment
- Major depressive disorder
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 |
|---|---|---|
| Power/resistance exercise programparticipants will complete a power/resistance program during 14 weeks. The exercise program will consist of training to improve muscle strength, neuromotor skills, flexibility, endurance, and a greater emphasis on maximum strength and power. The intensity will be set according the estimated repetition to failure. | Other | Power/resistance exercise, Power/resistance exercise + HMB |
| HMB supplementationDaily oral supplementation with 237 ml of a polymeric nutritional formula added with 1.5 g of HMB (Ensure Advance®) | Dietary supplement | Power/resistance exercise + HMB |
Primary outcome
Mean change from baseline arm Muscle Quality Index (MQIarm)
Time frame: Baseline and 14 weeks
The muscle quality index from dominant arm will be calculated with data obtained from hand grip strength, and lean mass obtained by bioimpedance analysis according with the formula: MQIarm = hand grip strength (kg) / arm lean mass (kg)
Mean change from baseline leg Muscle Quality Index (MQIleg)
Time frame: Baseline and 14 weeks
The muscle quality index from dominant leg will be calculated with data obtained by isokinetic, and lean mass obtained by bioimpedance analysis according with the formula: MQIleg = peak torque (Nm) / leg lean mass (kg)
3 secondary outcomes
Mean change from baseline muscular power
Time frame: Baseline and 14 weeks
Short Physical Performance Battery (SPPB)
Time frame: Baseline and 14 weeks
Health-related quality of life
Time frame: Baseline and 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Background: PubMed 25655372Fragala MS, Kenny AM, Kuchel GA. Muscle quality in aging: a multi-dimensional approach to muscle functioning with applications for treatment. Sports Med. 2015 May;45(5):641-58. doi: 10.1007/s40279-015-0305-z.
- Background: PubMed 25945152Barbieri E, Agostini D, Polidori E, Potenza L, Guescini M, Lucertini F, Annibalini G, Stocchi L, De Santi M, Stocchi V. The pleiotropic effect of physical exercise on mitochondrial dynamics in aging skeletal muscle. Oxid Med Cell Longev. 2015;2015:917085. doi: 10.1155/2015/917085. Epub 2015 Apr 5.
- Background: PubMed 22238004Barbat-Artigas S, Rolland Y, Zamboni M, Aubertin-Leheudre M. How to assess functional status: a new muscle quality index. J Nutr Health Aging. 2012 Jan;16(1):67-77. doi: 10.1007/s12603-012-0004-5.
- Background: PubMed 30312372Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
- Background: PubMed 23981904Stout JR, Smith-Ryan AE, Fukuda DH, Kendall KL, Moon JR, Hoffman JR, Wilson JM, Oliver JS, Mustad VA. Effect of calcium beta-hydroxy-beta-methylbutyrate (CaHMB) with and without resistance training in men and women 65+yrs: a randomized, double-blind pilot trial. Exp Gerontol. 2013 Nov;48(11):1303-10. doi: 10.1016/j.exger.2013.08.007. Epub 2013 Aug 24.
- Background: PubMed 24682351Cooper R, Hardy R, Bann D, Aihie Sayer A, Ward KA, Adams JE, Kuh D; MRC National Survey of Health and Development Scientific and Data Collection Team. Body mass index from age 15 years onwards and muscle mass, strength, and quality in early old age: findings from the MRC National Survey of Health and Development. J Gerontol A Biol Sci Med Sci. 2014 Oct;69(10):1253-9. doi: 10.1093/gerona/glu039. Epub 2014 Mar 28.
- Background: PubMed 28493406Holecek M. Beta-hydroxy-beta-methylbutyrate supplementation and skeletal muscle in healthy and muscle-wasting conditions. J Cachexia Sarcopenia Muscle. 2017 Aug;8(4):529-541. doi: 10.1002/jcsm.12208. Epub 2017 May 10.
- Background: PubMed 26573541He X, Duan Y, Yao K, Li F, Hou Y, Wu G, Yin Y. beta-Hydroxy-beta-methylbutyrate, mitochondrial biogenesis, and skeletal muscle health. Amino Acids. 2016 Mar;48(3):653-664. doi: 10.1007/s00726-015-2126-7. Epub 2015 Nov 14.
- Background: PubMed 15304540Barry BK, Carson RG. The consequences of resistance training for movement control in older adults. J Gerontol A Biol Sci Med Sci. 2004 Jul;59(7):730-54. doi: 10.1093/gerona/59.7.m730.
- Background: PubMed 19588334Liu CJ, Latham NK. Progressive resistance strength training for improving physical function in older adults. Cochrane Database Syst Rev. 2009 Jul 8;2009(3):CD002759. doi: 10.1002/14651858.CD002759.pub2.
- Background: PubMed 24807079Wandrag L, Brett SJ, Frost G, Hickson M. Impact of supplementation with amino acids or their metabolites on muscle wasting in patients with critical illness or other muscle wasting illness: a systematic review. J Hum Nutr Diet. 2015 Aug;28(4):313-30. doi: 10.1111/jhn.12238. Epub 2014 May 8.
- Background: PubMed 28698222Morton RW, Murphy KT, McKellar SR, Schoenfeld BJ, Henselmans M, Helms E, Aragon AA, Devries MC, Banfield L, Krieger JW, Phillips SM. A systematic review, meta-analysis and meta-regression of the effect of protein supplementation on resistance training-induced gains in muscle mass and strength in healthy adults. Br J Sports Med. 2018 Mar;52(6):376-384. doi: 10.1136/bjsports-2017-097608. Epub 2017 Jul 11.
- Individual participant dataSharing planned: No
Related trials for Aging Well
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Lung Cancer and Aging: Improving Well-being for Older Adults With Lung Cancer
Lung Cancer
Recruiting
Study Evaluating the Effect of Humiome® Post LB on Stress, Anxiety, and Cognition in Aging Adults
Healthy Aging
Recruiting
Effects of Breathing Exercises on Cognition in Older Adults
Older Adults (65 Years and Older), Cognition
Not yet recruiting
Eccentric Exercise in Community-dwelling Older Adults
Ageing Well
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.
Ariadna d Morales, MD principal investigator
National Institute of Rehabilitation
Questions about this trial
What is this clinical trial studying?
A study testing Power/resistance exercise program and HMB supplementation in people with Aging Well, run by Instituto Nacional de Rehabilitacion.
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 6 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: status not confirmed, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Andrea P Pérez, MSc (52 55 5999 1000 ext. 15302, apegueros@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline arm Muscle Quality Index (MQIarm) (time frame: Baseline and 14 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04734951, which also lists 20 linked publications.
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 20 Mar 2023.