SarcopeniaPhase 1NCT00891696
Nutritional and Contractile Regulation of Muscle Growth
A Phase 1 study testing Rapamycin, Amino acid supplementation and Low-intensity resistance exercise in people with Sarcopenia, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
Muscle wasting, which involves the loss of muscle tissue, is common in many conditions, such as cancer, AIDS, trauma, kidney failure, bone fracture, and sepsis. It is also prevalent among the elderly and in people who experience periods of physical inactivity and weightlessness. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Rapamycin, Amino acid supplementation and Low-intensity resistance exercise
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Mar 2015
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 to 35 years of age for the young groups
- 60 to 85 years of age for the older groups
- In the follicular phase for the young women participants
- Ability to sign consent form, as based on a score of greater than 25 on the 30-item Mini Mental State Examination (MMSE)
- Stable body weight for at least 1 year
Who cannot join
- Physical dependence or frailty, as determined by impairment in any of the activities of daily living (ADLs), history of more than two falls per year, or significant weight loss in the past year
- Exercise training that consists of more than two weekly sessions of moderate to high intensity aerobic or resistance exercise
- Significant heart, liver, kidney, blood, or respiratory disease
- Peripheral vascular disease
- Diabetes mellitus or other untreated endocrine disease
- Active cancer
Show all 14Show fewer
- History of cancer for participants who may be randomly assigned to rapamycin)
- Acute infectious disease or history of chronic infections (e.g., tuberculosis, hepatitis, HIV, herpes)
- Treatment with anabolic steroids or corticosteroids within 6 months of study entry
- Alcohol or drug abuse
- Tobacco use (smoking or chewing)
- Malnutrition (e.g., body mass index [BMI] less than 20 kg/m2, hypoalbuminemia, and/or hypotransferrinemia)
- Obesity (BMI greater than 30 kg/m2)
- Lower than normal hemoglobin levels
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Nutrition & Metabolism, University of Texas Medical Branch
Galveston, Texas, 77550
About this study
Official title: Nutritional and Contractile Regulation of Muscle Growth (Cycle 2)
Muscle wasting, which involves the loss of muscle tissue, is common in many conditions, such as cancer, AIDS, trauma, kidney failure, bone fracture, and sepsis. It is also prevalent among the elderly and in people who experience periods of physical inactivity and weightlessness. Muscle wasting can lead to overall weakness, immobility, physical dependence, and a greater risk of death when exposed to infection, surgery, or trauma. There is a need to develop scientifically based treatments that prevent muscle wasting. As one step towards such a goal, this study will examine the physiological and cellular mechanisms that regulate skeletal muscle growth.
Read the detailed description
Skeletal muscle comprises about 40% of one's body weight and contains about 50% to 75% of all the proteins in the human body. The turnover of protein is a regular process in the human body. In healthy adults, the interplay between muscle protein synthesis and muscle protein breakdown results in no net growth or loss of muscle mass. But when the scale tips towards muscle protein breakdown, muscle wasting can occur. This can result in negative consequences, because not only does muscle fill the obvious role of converting chemical energy into mechanical energy for moving and maintaining posture, but muscle is also involved in the following less apparent roles: regulating metabolism; removing potentially toxic substances from blood circulation; producing fuel for other tissues; storing energy and nitrogen, both of which are important for fueling the brain and immune system; and facilitating wound healing during malnutrition, starvation, injury, and disease. Therefore, muscle is important not only for physical independence but also for mere survival of the human body. In fact, a mere 30% loss of the body's proteins results in impaired respiration and circulation and can eventually lead to death. The purpose of this study is to examine the physiological and cellular mechanisms that regulate skeletal muscle growth. Results from the study may help to develop future treatments for maintaining and possibly increasing muscle mass as a way to improve function, reduce disease complications, and increase survival.
This study will enroll healthy participants who will be randomly assigned to one of several treatment arms within one of three separate experiments. Overall, the three experiments will examine the following: (1) whether the mammalian target of rapamycin (mTOR) signaling pathway--a group of molecules that work together to control a specific cellular function--is responsible for stimulating muscle protein synthesis after resistance exercise and/or ingestion of an amino acid supplement; (2) whether restricting blood flow with a blood pressure cuff during low-intensity resistance exercise ultimately leads to muscle protein synthesis; and (3) whether aging is associated with reduced physiological and cellular mechanisms that are related to muscle protein synthesis and whether such a reduction can be overcome by post-exercise ingestion of an amino acid supplement or blood flow restriction during low-intensity resistance exercise.
Depending on which treatment arm participants are assigned to, they may receive amino acid supplementation, the drug rapamycin, the drug sodium nitroprusside, and/or placebo. They may also undergo high-intensity resistance exercise, low-intensity resistance exercise, or low-intensity resistance exercise along with blood flow restriction. All participants will attend a single 8-hour study visit and a follow-up visit 1 week later. During the study visit, participants will undergo the following: measurements of vital signs, height, and weight; blood and urine sampling; a dual energy x-ray absorptiometry (DEXA) scan; and an infusion study that will include additional blood sampling, muscle biopsies, and assigned interventions. The follow-up visit will include evaluation of any incisions that were made during the infusion study.
- Conditions
- Sarcopenia
- Being tested
- Rapamycin, Amino acid supplementation, Low-intensity resistance exercise, Sodium nitroprusside, Blood flow restriction cuff
- Keywords
- Sarcopenia, Aging, Metabolism, Muscle, mTOR, Essential Amino Acids, Exercise, Rapamycin
- Medical subject headings
- Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RapamycinDrug
Single 16-mg oral dose
Amino acid supplementationOther
Nutritional drink containing essential amino acids
Low-intensity resistance exerciseOther
Leg extension exercises on a Cybex leg extension machine
Sodium nitroprussideDrug
Variable rate for 3 hours
Blood flow restriction cuffDevice
Also called KAATSU cuff
Blood flow restriction for 5 minutes after the second biopsy
Low-intensity resistance exerciseOther
Leg extension exercises on a Cybex leg extension machine
| Study group | Role | What they receive |
|---|---|---|
| Exp 1: AA + Rap | Active comparator | Participants will receive amino acid supplementation and rapamycin. Receives: Drug: Rapamycin; Other: Amino acid supplementation |
| Exp 1: AA | Placebo comparator | Participants will receive amino acid supplementation and placebo rapamycin. Receives: Other: Amino acid supplementation |
| Exp 1: HEx + Rap | Active comparator | Participants will receive rapamycin and placebo amino acid supplementation, and they will undergo high-intensity resistance exercise. Receives: Drug: Rapamycin; Other: Low-intensity resistance exercise |
| Exp 1: HEx | Placebo comparator | Participants will receive placebo amino acid supplementation and placebo rapamycin, and they will undergo high-intensity resistance exercise. Receives: Other: Low-intensity resistance exercise |
| Exp 1: HEx + AA + Rap | Active comparator | Participants will receive amino acid supplementation and rapamycin, and they will undergo high-intensity resistance exercise. Receives: Drug: Rapamycin; Other: Amino acid supplementation; Other: Low-intensity resistance exercise |
| Exp 1: HEx + AA | Placebo comparator | Participants will receive amino acid supplementation and placebo rapamycin, and they will undergo high-intensity resistance exercise. Receives: Other: Amino acid supplementation; Other: Low-intensity resistance exercise |
| Exp 2: LExFR + Rap | Active comparator | Participants will receive rapamycin and will undergo low-intensity resistance exercise with blood flow restriction. Receives: Drug: Rapamycin; Device: Blood flow restriction cuff; Other: Low-intensity resistance exercise |
| Exp 2 and 3: LExFR | Placebo comparator | Participants will receive placebo rapamycin and will undergo low-intensity resistance exercise with blood flow restriction. Receives: Device: Blood flow restriction cuff; Other: Low-intensity resistance exercise |
| Exp 2: SNP | Active comparator | Participants will receive sodium nitroprusside in a resting state. Receives: Drug: Sodium nitroprusside |
| Exp 2: FR | Active comparator | Participants will undergo blood flow restriction in a resting state. Receives: Device: Blood flow restriction cuff |
| Exp 2: LEx + SNP | Active comparator | Participants will receive sodium nitroprusside and undergo low-intensity resistance exercise. Receives: Drug: Sodium nitroprusside; Other: Low-intensity resistance exercise |
| Exp 3: LEx | Placebo comparator | Participants will undergo low-intensity resistance exercise. Receives: Other: Low-intensity resistance exercise |
| Exp 3: HEx | Active comparator | Participants will undergo high-intensity resistance exercise. Receives: Other: Low-intensity resistance exercise |
| Exp 3: HEx + AA | Active comparator | Participants will receive amino acid supplementation and will undergo high-intensity resistance exercise. Receives: Other: Low-intensity resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle protein synthesis
Measured: Measured during the 8-hour infusion study
Secondary outcomes (1)
Phosphorylation status of mTOR signaling proteins
Measured: Measured during the 8-hour infusion study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2009 (estimated)
- Study startApr 2009
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Blake Rasmussen, PhD, Principal investigator, The University of Texas Medical Branch, Galveston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00891696
- Sponsor's protocol ID
- 08-306
- Other IDs
- R01AR049877
- Status last verified
- Jun 2015
- First submitted
- 29 Apr 2009
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Fujita S, Dreyer HC, Drummond MJ, Glynn EL, Volpi E, Rasmussen BB. Essential amino acid and carbohydrate ingestion before resistance exercise does not enhance postexercise muscle protein synthesis. J Appl Physiol (1985). 2009 May;106(5):1730-9. doi: 10.1152/japplphysiol.90395.2008. Epub 2008 Jun 5.
PubMed 18535123Volpi E, Chinkes DL, Rasmussen BB. Sequential muscle biopsies during a 6-h tracer infusion do not affect human mixed muscle protein synthesis and muscle phenylalanine kinetics. Am J Physiol Endocrinol Metab. 2008 Oct;295(4):E959-63. doi: 10.1152/ajpendo.00671.2007. Epub 2008 Aug 19.
PubMed 18713956Drummond MJ, Miyazaki M, Dreyer HC, Pennings B, Dhanani S, Volpi E, Esser KA, Rasmussen BB. Expression of growth-related genes in young and older human skeletal muscle following an acute stimulation of protein synthesis. J Appl Physiol (1985). 2009 Apr;106(4):1403-11. doi: 10.1152/japplphysiol.90842.2008. Epub 2008 Sep 11.
PubMed 18787087Drummond MJ, McCarthy JJ, Fry CS, Esser KA, Rasmussen BB. Aging differentially affects human skeletal muscle microRNA expression at rest and after an anabolic stimulus of resistance exercise and essential amino acids. Am J Physiol Endocrinol Metab. 2008 Dec;295(6):E1333-40. doi: 10.1152/ajpendo.90562.2008. Epub 2008 Sep 30.
PubMed 18827171Drummond MJ, Fry CS, Glynn EL, Dreyer HC, Dhanani S, Timmerman KL, Volpi E, Rasmussen BB. Rapamycin administration in humans blocks the contraction-induced increase in skeletal muscle protein synthesis. J Physiol. 2009 Apr 1;587(Pt 7):1535-46. doi: 10.1113/jphysiol.2008.163816. Epub 2009 Feb 2.
PubMed 19188252Drummond MJ, Glynn EL, Fry CS, Dhanani S, Volpi E, Rasmussen BB. Essential amino acids increase microRNA-499, -208b, and -23a and downregulate myostatin and myocyte enhancer factor 2C mRNA expression in human skeletal muscle. J Nutr. 2009 Dec;139(12):2279-84. doi: 10.3945/jn.109.112797. Epub 2009 Oct 14.
PubMed 19828686Dreyer HC, Fujita S, Glynn EL, Drummond MJ, Volpi E, Rasmussen BB. Resistance exercise increases leg muscle protein synthesis and mTOR signalling independent of sex. Acta Physiol (Oxf). 2010 May;199(1):71-81. doi: 10.1111/j.1748-1716.2010.02074.x. Epub 2010 Jan 12.
PubMed 20070283Fry CS, Glynn EL, Drummond MJ, Timmerman KL, Fujita S, Abe T, Dhanani S, Volpi E, Rasmussen BB. Blood flow restriction exercise stimulates mTORC1 signaling and muscle protein synthesis in older men. J Appl Physiol (1985). 2010 May;108(5):1199-209. doi: 10.1152/japplphysiol.01266.2009. Epub 2010 Feb 11.
PubMed 20150565Drummond MJ, Glynn EL, Fry CS, Timmerman KL, Volpi E, Rasmussen BB. An increase in essential amino acid availability upregulates amino acid transporter expression in human skeletal muscle. Am J Physiol Endocrinol Metab. 2010 May;298(5):E1011-8. doi: 10.1152/ajpendo.00690.2009. Epub 2010 Feb 9.
PubMed 20304764Glynn EL, Fry CS, Drummond MJ, Dreyer HC, Dhanani S, Volpi E, Rasmussen BB. Muscle protein breakdown has a minor role in the protein anabolic response to essential amino acid and carbohydrate intake following resistance exercise. Am J Physiol Regul Integr Comp Physiol. 2010 Aug;299(2):R533-40. doi: 10.1152/ajpregu.00077.2010. Epub 2010 Jun 2.
PubMed 20519362Glynn EL, Fry CS, Drummond MJ, Timmerman KL, Dhanani S, Volpi E, Rasmussen BB. Excess leucine intake enhances muscle anabolic signaling but not net protein anabolism in young men and women. J Nutr. 2010 Nov;140(11):1970-6. doi: 10.3945/jn.110.127647. Epub 2010 Sep 15.
PubMed 20844186Drummond MJ, McCarthy JJ, Sinha M, Spratt HM, Volpi E, Esser KA, Rasmussen BB. Aging and microRNA expression in human skeletal muscle: a microarray and bioinformatics analysis. Physiol Genomics. 2011 May 1;43(10):595-603. doi: 10.1152/physiolgenomics.00148.2010. Epub 2010 Sep 28.
PubMed 20876843Dickinson JM, Fry CS, Drummond MJ, Gundermann DM, Walker DK, Glynn EL, Timmerman KL, Dhanani S, Volpi E, Rasmussen BB. Mammalian target of rapamycin complex 1 activation is required for the stimulation of human skeletal muscle protein synthesis by essential amino acids. J Nutr. 2011 May;141(5):856-62. doi: 10.3945/jn.111.139485. Epub 2011 Mar 23.
PubMed 21430254Drummond MJ, Fry CS, Glynn EL, Timmerman KL, Dickinson JM, Walker DK, Gundermann DM, Volpi E, Rasmussen BB. Skeletal muscle amino acid transporter expression is increased in young and older adults following resistance exercise. J Appl Physiol (1985). 2011 Jul;111(1):135-42. doi: 10.1152/japplphysiol.01408.2010. Epub 2011 Apr 28.
PubMed 21527663Fry CS, Drummond MJ, Glynn EL, Dickinson JM, Gundermann DM, Timmerman KL, Walker DK, Dhanani S, Volpi E, Rasmussen BB. Aging impairs contraction-induced human skeletal muscle mTORC1 signaling and protein synthesis. Skelet Muscle. 2011 Mar 2;1(1):11. doi: 10.1186/2044-5040-1-11.
PubMed 21798089
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional and Contractile Regulation of Muscle Growth (Cycle 2)
- ClinicalTrials.gov ID
- NCT00891696
- Acronym / sponsor ID
- 08-306
- Conditions
- Sarcopenia
- Keywords
- Sarcopenia, Aging, Metabolism, Muscle, mTOR, Essential Amino Acids, Exercise, Rapamycin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Apr 2009
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 1 May 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.
Muscle wasting, which involves the loss of muscle tissue, is common in many conditions, such as cancer, AIDS, trauma, kidney failure, bone fracture, and sepsis. It is also prevalent among the elderly and in people who experience periods of physical inactivity and weightlessness. Muscle wasting can lead to overall weakness, immobility, physical dependence, and a greater risk of death when exposed to infection, surgery, or trauma. There is a need to develop scientifically based treatments that prevent muscle wasting. As one step towards such a goal, this study will examine the physiological and cellular mechanisms that regulate skeletal muscle growth.
Detailed description
Skeletal muscle comprises about 40% of one's body weight and contains about 50% to 75% of all the proteins in the human body. The turnover of protein is a regular process in the human body. In healthy adults, the interplay between muscle protein synthesis and muscle protein breakdown results in no net growth or loss of muscle mass. But when the scale tips towards muscle protein breakdown, muscle wasting can occur. This can result in negative consequences, because not only does muscle fill the obvious role of converting chemical energy into mechanical energy for moving and maintaining posture, but muscle is also involved in the following less apparent roles: regulating metabolism; removing potentially toxic substances from blood circulation; producing fuel for other tissues; storing energy and nitrogen, both of which are important for fueling the brain and immune system; and facilitating wound healing during malnutrition, starvation, injury, and disease. Therefore, muscle is important not only for physical independence but also for mere survival of the human body. In fact, a mere 30% loss of the body's proteins results in impaired respiration and circulation and can eventually lead to death. The purpose of this study is to examine the physiological and cellular mechanisms that regulate skeletal muscle growth. Results from the study may help to develop future treatments for maintaining and possibly increasing muscle mass as a way to improve function, reduce disease complications, and increase survival.
This study will enroll healthy participants who will be randomly assigned to one of several treatment arms within one of three separate experiments. Overall, the three experiments will examine the following: (1) whether the mammalian target of rapamycin (mTOR) signaling pathway--a group of molecules that work together to control a specific cellular function--is responsible for stimulating muscle protein synthesis after resistance exercise and/or ingestion of an amino acid supplement; (2) whether restricting blood flow with a blood pressure cuff during low-intensity resistance exercise ultimately leads to muscle protein synthesis; and (3) whether aging is associated with reduced physiological and cellular mechanisms that are related to muscle protein synthesis and whether such a reduction can be overcome by post-exercise ingestion of an amino acid supplement or blood flow restriction during low-intensity resistance exercise.
Depending on which treatment arm participants are assigned to, they may receive amino acid supplementation, the drug rapamycin, the drug sodium nitroprusside, and/or placebo. They may also undergo high-intensity resistance exercise, low-intensity resistance exercise, or low-intensity resistance exercise along with blood flow restriction. All participants will attend a single 8-hour study visit and a follow-up visit 1 week later. During the study visit, participants will undergo the following: measurements of vital signs, height, and weight; blood and urine sampling; a dual energy x-ray absorptiometry (DEXA) scan; and an infusion study that will include additional blood sampling, muscle biopsies, and assigned interventions. The follow-up visit will include evaluation of any incisions that were made during the infusion study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Exp 1: AA + Rap | Active comparator | Drug: Rapamycin, Other: Amino acid supplementationParticipants will receive amino acid supplementation and rapamycin. |
| Exp 1: AA | Placebo comparator | Other: Amino acid supplementationParticipants will receive amino acid supplementation and placebo rapamycin. |
| Exp 1: HEx + Rap | Active comparator | Drug: Rapamycin, Other: Low-intensity resistance exerciseParticipants will receive rapamycin and placebo amino acid supplementation, and they will undergo high-intensity resistance exercise. |
| Exp 1: HEx | Placebo comparator | Other: Low-intensity resistance exerciseParticipants will receive placebo amino acid supplementation and placebo rapamycin, and they will undergo high-intensity resistance exercise. |
| Exp 1: HEx + AA + Rap | Active comparator | Drug: Rapamycin, Other: Amino acid supplementation, Other: Low-intensity resistance exerciseParticipants will receive amino acid supplementation and rapamycin, and they will undergo high-intensity resistance exercise. |
| Exp 1: HEx + AA | Placebo comparator | Other: Amino acid supplementation, Other: Low-intensity resistance exerciseParticipants will receive amino acid supplementation and placebo rapamycin, and they will undergo high-intensity resistance exercise. |
| Exp 2: LExFR + Rap | Active comparator | Drug: Rapamycin, Device: Blood flow restriction cuff, Other: Low-intensity resistance exerciseParticipants will receive rapamycin and will undergo low-intensity resistance exercise with blood flow restriction. |
| Exp 2 and 3: LExFR | Placebo comparator | Device: Blood flow restriction cuff, Other: Low-intensity resistance exerciseParticipants will receive placebo rapamycin and will undergo low-intensity resistance exercise with blood flow restriction. |
| Exp 2: SNP | Active comparator | Drug: Sodium nitroprussideParticipants will receive sodium nitroprusside in a resting state. |
| Exp 2: FR | Active comparator | Device: Blood flow restriction cuffParticipants will undergo blood flow restriction in a resting state. |
| Exp 2: LEx + SNP | Active comparator | Drug: Sodium nitroprusside, Other: Low-intensity resistance exerciseParticipants will receive sodium nitroprusside and undergo low-intensity resistance exercise. |
| Exp 3: LEx | Placebo comparator | Other: Low-intensity resistance exerciseParticipants will undergo low-intensity resistance exercise. |
| Exp 3: HEx | Active comparator | Other: Low-intensity resistance exerciseParticipants will undergo high-intensity resistance exercise. |
| Exp 3: HEx + AA | Active comparator | Other: Low-intensity resistance exerciseParticipants will receive amino acid supplementation and will undergo high-intensity resistance exercise. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 to 35 years of age for the young groups
- 60 to 85 years of age for the older groups
- In the follicular phase for the young women participants
- Ability to sign consent form, as based on a score of greater than 25 on the 30-item Mini Mental State Examination (MMSE)
- Stable body weight for at least 1 year
Key exclusion criteria (14 listed)
- Physical dependence or frailty, as determined by impairment in any of the activities of daily living (ADLs), history of more than two falls per year, or significant weight loss in the past year
- Exercise training that consists of more than two weekly sessions of moderate to high intensity aerobic or resistance exercise
- Significant heart, liver, kidney, blood, or respiratory disease
- Peripheral vascular disease
- Diabetes mellitus or other untreated endocrine 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 |
|---|---|---|
| RapamycinSingle 16-mg oral dose | Drug | Exp 1: AA + Rap, Exp 1: HEx + AA + Rap, Exp 1: HEx + Rap, Exp 2: LExFR + Rap |
| Amino acid supplementationNutritional drink containing essential amino acids | Other | Exp 1: AA, Exp 1: AA + Rap, Exp 1: HEx + AA, Exp 1: HEx + AA + Rap |
| Low-intensity resistance exerciseLeg extension exercises on a Cybex leg extension machine | Other | Exp 1: HEx, Exp 1: HEx + AA, Exp 1: HEx + AA + Rap, Exp 1: HEx + Rap, Exp 3: HEx, Exp 3: HEx + AA |
| Sodium nitroprussideVariable rate for 3 hours | Drug | Exp 2: LEx + SNP, Exp 2: SNP |
| Blood flow restriction cuffAlso: KAATSU cuffBlood flow restriction for 5 minutes after the second biopsy | Device | Exp 2 and 3: LExFR, Exp 2: FR, Exp 2: LExFR + Rap |
| Low-intensity resistance exerciseLeg extension exercises on a Cybex leg extension machine | Other | Exp 2 and 3: LExFR, Exp 2: LEx + SNP, Exp 2: LExFR + Rap, Exp 3: LEx |
Primary outcome
Muscle protein synthesis
Time frame: Measured during the 8-hour infusion study
1 secondary outcome
Phosphorylation status of mTOR signaling proteins
Time frame: Measured during the 8-hour infusion study
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 4 May 2017.
- Results publication: PubMed 18535123Fujita S, Dreyer HC, Drummond MJ, Glynn EL, Volpi E, Rasmussen BB. Essential amino acid and carbohydrate ingestion before resistance exercise does not enhance postexercise muscle protein synthesis. J Appl Physiol (1985). 2009 May;106(5):1730-9. doi: 10.1152/japplphysiol.90395.2008. Epub 2008 Jun 5.
- Results publication: PubMed 18713956Volpi E, Chinkes DL, Rasmussen BB. Sequential muscle biopsies during a 6-h tracer infusion do not affect human mixed muscle protein synthesis and muscle phenylalanine kinetics. Am J Physiol Endocrinol Metab. 2008 Oct;295(4):E959-63. doi: 10.1152/ajpendo.00671.2007. Epub 2008 Aug 19.
- Results publication: PubMed 18787087Drummond MJ, Miyazaki M, Dreyer HC, Pennings B, Dhanani S, Volpi E, Esser KA, Rasmussen BB. Expression of growth-related genes in young and older human skeletal muscle following an acute stimulation of protein synthesis. J Appl Physiol (1985). 2009 Apr;106(4):1403-11. doi: 10.1152/japplphysiol.90842.2008. Epub 2008 Sep 11.
- Results publication: PubMed 18827171Drummond MJ, McCarthy JJ, Fry CS, Esser KA, Rasmussen BB. Aging differentially affects human skeletal muscle microRNA expression at rest and after an anabolic stimulus of resistance exercise and essential amino acids. Am J Physiol Endocrinol Metab. 2008 Dec;295(6):E1333-40. doi: 10.1152/ajpendo.90562.2008. Epub 2008 Sep 30.
- Results publication: PubMed 19188252Drummond MJ, Fry CS, Glynn EL, Dreyer HC, Dhanani S, Timmerman KL, Volpi E, Rasmussen BB. Rapamycin administration in humans blocks the contraction-induced increase in skeletal muscle protein synthesis. J Physiol. 2009 Apr 1;587(Pt 7):1535-46. doi: 10.1113/jphysiol.2008.163816. Epub 2009 Feb 2.
- Results publication: PubMed 19828686Drummond MJ, Glynn EL, Fry CS, Dhanani S, Volpi E, Rasmussen BB. Essential amino acids increase microRNA-499, -208b, and -23a and downregulate myostatin and myocyte enhancer factor 2C mRNA expression in human skeletal muscle. J Nutr. 2009 Dec;139(12):2279-84. doi: 10.3945/jn.109.112797. Epub 2009 Oct 14.
- Results publication: PubMed 20070283Dreyer HC, Fujita S, Glynn EL, Drummond MJ, Volpi E, Rasmussen BB. Resistance exercise increases leg muscle protein synthesis and mTOR signalling independent of sex. Acta Physiol (Oxf). 2010 May;199(1):71-81. doi: 10.1111/j.1748-1716.2010.02074.x. Epub 2010 Jan 12.
- Results publication: PubMed 20150565Fry CS, Glynn EL, Drummond MJ, Timmerman KL, Fujita S, Abe T, Dhanani S, Volpi E, Rasmussen BB. Blood flow restriction exercise stimulates mTORC1 signaling and muscle protein synthesis in older men. J Appl Physiol (1985). 2010 May;108(5):1199-209. doi: 10.1152/japplphysiol.01266.2009. Epub 2010 Feb 11.
- Results publication: PubMed 20304764Drummond MJ, Glynn EL, Fry CS, Timmerman KL, Volpi E, Rasmussen BB. An increase in essential amino acid availability upregulates amino acid transporter expression in human skeletal muscle. Am J Physiol Endocrinol Metab. 2010 May;298(5):E1011-8. doi: 10.1152/ajpendo.00690.2009. Epub 2010 Feb 9.
- Results publication: PubMed 20519362Glynn EL, Fry CS, Drummond MJ, Dreyer HC, Dhanani S, Volpi E, Rasmussen BB. Muscle protein breakdown has a minor role in the protein anabolic response to essential amino acid and carbohydrate intake following resistance exercise. Am J Physiol Regul Integr Comp Physiol. 2010 Aug;299(2):R533-40. doi: 10.1152/ajpregu.00077.2010. Epub 2010 Jun 2.
- Results publication: PubMed 20844186Glynn EL, Fry CS, Drummond MJ, Timmerman KL, Dhanani S, Volpi E, Rasmussen BB. Excess leucine intake enhances muscle anabolic signaling but not net protein anabolism in young men and women. J Nutr. 2010 Nov;140(11):1970-6. doi: 10.3945/jn.110.127647. Epub 2010 Sep 15.
- Results publication: PubMed 20876843Drummond MJ, McCarthy JJ, Sinha M, Spratt HM, Volpi E, Esser KA, Rasmussen BB. Aging and microRNA expression in human skeletal muscle: a microarray and bioinformatics analysis. Physiol Genomics. 2011 May 1;43(10):595-603. doi: 10.1152/physiolgenomics.00148.2010. Epub 2010 Sep 28.
- Individual participant dataSharing planned: No
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Kidney Transplantation, Physical Function
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
MF-300 for Treatment of Age-Related Sarcopenia
Sarcopenia in Elderly
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
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.
Blake Rasmussen, PhD principal investigator
The University of Texas Medical Branch, Galveston
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 Rapamycin, Amino acid supplementation and Low-intensity resistance exercise in people with Sarcopenia, run by The University of Texas Medical Branch, Galveston 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 5 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 4 May 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.
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?
Muscle protein synthesis (time frame: Measured during the 8-hour infusion study). 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 NCT00891696, which also lists 48 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 4 May 2017.