Frail ElderlyNCT01922167
Resistance Exercise Training and Amino Acid Leucine Supplementation in Frail Elderly Women
A study testing Leucine and Alanine in people with Frail Elderly, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in Canada.
Trial summary
Frailty is a clinical entity associated with an increase in risk for disease and death and becomes more common as people age. Frailty has a strong relationship with the age-related loss of muscle and strength, termed sarcopenia. Sarcopenia and frailty are strongly associated with disability, especially in women. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Frail Elderly
- What is being tested?
- Leucine and Alanine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 2 sitesCanada
- Study dates
- Nov 2013to 17 Dec 2018
- 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 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Mini Mental State Examination score > 24
- Time up and go test < 17 s
- Stable weight and diet
- No acute disease
- Body mass index (BMI) 20-35 kg/m^2
- Normal complete blood count (CBC), biochemistry, glycated hemoglobin (A1C), lipid profile, thyroid stimulating hormone (TSH)
Show all 11Show fewer
- Non-diabetic (Oral Glucose Tolerance Test)
- Negative serology for hepatitis and human immunodeficiency virus (HIV)
- Normal chest X-Ray, electrocardiogram (ECG) and urine analysis
- Non-disabled
- Provide informed consent
Who cannot join
- Eating disorder,
- Food allergies affecting diet
- Substance abuse
- Active medical conditions including diabetes and any cancer other than skin within 5 years
- Serum creatinine > 110 umol/L, Hb < 110 g/L
- Medications known to interfere with the metabolic endpoint measurements: diuretics, beta-blockers, bronchodilators, non-steroidal anti-inflammatory drugs (NSAIDs), antianginals, antiarrythmics and steroids (other than topical)
- Disability
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Institut Universitaire de Gériatrie de Montréal
Montreal, Quebec, H3W 1W5
Royal Victoria Hospital - Glen Site
Montreal, Quebec, H4A 3J1
About this study
Official title: The Impact of Exercise Training and Leucine Supplementation in Frail Elderly Women With an Exploration Into Mechanistic Explanations
Frailty is a clinical entity associated with an increase in risk for disease and death and becomes more common as people age. Frailty has a strong relationship with the age-related loss of muscle and strength, termed sarcopenia. Sarcopenia and frailty are strongly associated with disability, especially in women. Adequate protein intake, the amino acid leucine, and resistance exercise training have been individually shown to increase muscle mass to varying degrees. However, no studies have investigated how a longer-term resistance exercise training program with leucine supplementation when protein intake is optimized could increase muscle mass in frail and pre-frail elderly women. In addition, this is the population that stands the most to gain from such an intervention.
The purpose of this study is to investigate the effects of the amino acid leucine added to resistance exercise training on muscle mass and physical performance in frail and pre-frail elderly women with adequate protein intake. We hypothesize that combining leucine in diet with an exercise program would be superior to exercise alone in stimulating muscle protein synthesis and phosphorylation status of muscle cellular key-regulatory proteins, leading to enhanced gains in muscle performance.
Read more
A total of 24 subjects will take part in this study, conducted at the McGill University Health Centre (MUHC) Royal Victoria Hospital and the Institut Universitaire de Gériatrie de Montréal (IUGM). All subjects will undergo adjustments to their diet to optimize protein intake and a resistance exercise training program. Half of the participants will receive a supplement of powdered leucine (an amino acid), and the other half of the participants will receive a placebo in the same powder form. Neither the participants nor the study investigators will know which participants are receiving the leucine nor which are receiving the placebo.
Each subjects participation in this study will involve 4 total visits: 2 initial screening visits followed by 2 two-day stays at the Centre for Innovative Medicine (CIM) of the MUHC-Royal Victoria Hospital. These two stays will be spaced by 12 weeks of the intervention (dietary adjustments, resistance exercise training, and the powdered supplement). The two stays each consist of a meal test to assess each subjects metabolic responses to a meal, and to obtain muscle biopsies necessary to measure the rate of protein accumulation in the muscle. Simple physical performance measurements will be taken before and at the completion of the intervention.
This study aims to better understand how the presence of aging affects the body's responses to resistance exercise and how leucine, one of the amino acids that make up proteins, may help build muscle. This in turn, could lead to defining combined diet and exercise strategies to prevent muscle loss often seen with aging.
- Conditions
- Frail Elderly
- Being tested
- Leucine, Alanine
- Keywords
- Aging, Frailty, Leucine, Resistance Exercise
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeucineDietary supplement
AlanineDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Leucine | Experimental | 2.5 g doses of leucine isolate three times per day (7.5 g total) of leucine, taken by mouth in powder form mixed with liquid for 12 consecutive weeks. Receives: Dietary Supplement: Leucine |
| Alanine | Placebo comparator | 2.5 g doses of alanine isolate three times per day (7.5 g total) of alanine, taken by mouth in powder form mixed with liquid for 12 consecutive weeks. Receives: Dietary Supplement: Alanine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Fractional Synthesis Rate (FSR) at 12 weeks
Measured: Baseline and at 12 weeks
Secondary outcomes (4)
Change from Baseline in Physical Performance at 12 weeks
Short Physical Performance Battery test, Timed-up-and-Go test 6 Minute Walk Test
1 repetition maximum Hand-grip strength
Measured: Baseline and at 12 weeks
Change from Baseline in Body Composition at 12 weeks
Dual energy X-ray absorptiometry
Measured: Baseline and at 12 weeks
Change from Baseline in Post-prandial responses at 12 weeks
Will measure excursion curves of glucose, insulin, branched chain amino acids, and amino acid profile
Measured: Baseline and at 12 weeks
Change from Baseline in Fasting levels at 12 weeks
Will measure fasting levels of insulin growth factor-1 (IGF-1), interleukin-6 (IL-6), cortisol, as well as resting metabolic rate
Measured: Baseline and at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startNov 2013
- Primary completion8 Feb 2018
- Study completion17 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Frail ElderlyStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Morais, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- José A Morais, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922167
- Sponsor's protocol ID
- MUHC-H-5461
- Status last verified
- Mar 2019
- First submitted
- 26 Jul 2013
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Jacob KJ, Sonjak V, Spendiff S, Hepple RT, Chevalier S, Perez A, Morais JA. Mitochondrial Content, but Not Function, Is Altered With a Multimodal Resistance Training Protocol and Adequate Protein Intake in Leucine-Supplemented Pre/Frail Women. Front Nutr. 2021 Jan 22;7:619216. doi: 10.3389/fnut.2020.619216. eCollection 2020.
PubMed 33553232Jacob KJ, Chevalier S, Lamarche M, Morais JA. Leucine Supplementation Does Not Alter Insulin Sensitivity in Prefrail and Frail Older Women following a Resistance Training Protocol. J Nutr. 2019 Jun 1;149(6):959-967. doi: 10.1093/jn/nxz038.
PubMed 31149709
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Exercise Training and Leucine Supplementation in Frail Elderly Women With an Exploration Into Mechanistic Explanations
- ClinicalTrials.gov ID
- NCT01922167
- Acronym / sponsor ID
- MUHC-H-5461
- Conditions
- Frail Elderly
- Keywords
- Aging, Frailty, Leucine, Resistance Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- 8 Feb 2018 (actual)
- Study completion
- 17 Dec 2018 (actual)
- First posted
- 14 Aug 2013 (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.
Frailty is a clinical entity associated with an increase in risk for disease and death and becomes more common as people age. Frailty has a strong relationship with the age-related loss of muscle and strength, termed sarcopenia. Sarcopenia and frailty are strongly associated with disability, especially in women. Adequate protein intake, the amino acid leucine, and resistance exercise training have been individually shown to increase muscle mass to varying degrees. However, no studies have investigated how a longer-term resistance exercise training program with leucine supplementation when protein intake is optimized could increase muscle mass in frail and pre-frail elderly women. In addition, this is the population that stands the most to gain from such an intervention.
The purpose of this study is to investigate the effects of the amino acid leucine added to resistance exercise training on muscle mass and physical performance in frail and pre-frail elderly women with adequate protein intake. We hypothesize that combining leucine in diet with an exercise program would be superior to exercise alone in stimulating muscle protein synthesis and phosphorylation status of muscle cellular key-regulatory proteins, leading to enhanced gains in muscle performance.
A total of 24 subjects will take part in this study, conducted at the McGill University Health Centre (MUHC) Royal Victoria Hospital and the Institut Universitaire de Gériatrie de Montréal (IUGM). All subjects will undergo adjustments to their diet to optimize protein intake and a resistance exercise training program. Half of the participants will receive a supplement of powdered leucine (an amino acid), and the other half of the participants will receive a placebo in the same powder form. Neither the participants nor the study investigators will know which participants are receiving the leucine nor which are receiving the placebo.
Each subjects participation in this study will involve 4 total visits: 2 initial screening visits followed by 2 two-day stays at the Centre for Innovative Medicine (CIM) of the MUHC-Royal Victoria Hospital. These two stays will be spaced by 12 weeks of the intervention (dietary adjustments, resistance exercise training, and the powdered supplement). The two stays each consist of a meal test to assess each subjects metabolic responses to a meal, and to obtain muscle biopsies necessary to measure the rate of protein accumulation in the muscle. Simple physical performance measurements will be taken before and at the completion of the intervention.
This study aims to better understand how the presence of aging affects the body's responses to resistance exercise and how leucine, one of the amino acids that make up proteins, may help build muscle. This in turn, could lead to defining combined diet and exercise strategies to prevent muscle loss often seen with aging.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leucine | Experimental | Dietary Supplement: Leucine2.5 g doses of leucine isolate three times per day (7.5 g total) of leucine, taken by mouth in powder form mixed with liquid for 12 consecutive weeks. |
| Alanine | Placebo comparator | Dietary Supplement: Alanine2.5 g doses of alanine isolate three times per day (7.5 g total) of alanine, taken by mouth in powder form mixed with liquid for 12 consecutive weeks. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- Mini Mental State Examination score > 24
- Time up and go test < 17 s
- Stable weight and diet
- No acute disease
- Body mass index (BMI) 20-35 kg/m^2
Key exclusion criteria (7 listed)
- Eating disorder,
- Food allergies affecting diet
- Substance abuse
- Active medical conditions including diabetes and any cancer other than skin within 5 years
- Serum creatinine > 110 umol/L, Hb < 110 g/L
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 |
|---|---|---|
| Leucine | Dietary supplement | Leucine |
| Alanine | Dietary supplement | Alanine |
Primary outcome
Change from Baseline in Fractional Synthesis Rate (FSR) at 12 weeks
Time frame: Baseline and at 12 weeks
4 secondary outcomes
Change from Baseline in Physical Performance at 12 weeks
Time frame: Baseline and at 12 weeks
Change from Baseline in Body Composition at 12 weeks
Time frame: Baseline and at 12 weeks
Change from Baseline in Post-prandial responses at 12 weeks
Time frame: Baseline and at 12 weeks
Change from Baseline in Fasting levels at 12 weeks
Time frame: Baseline and at 12 weeks
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 8 Mar 2019.
- Derived from this study: PubMed 33553232Jacob KJ, Sonjak V, Spendiff S, Hepple RT, Chevalier S, Perez A, Morais JA. Mitochondrial Content, but Not Function, Is Altered With a Multimodal Resistance Training Protocol and Adequate Protein Intake in Leucine-Supplemented Pre/Frail Women. Front Nutr. 2021 Jan 22;7:619216. doi: 10.3389/fnut.2020.619216. eCollection 2020.
- Derived from this study: PubMed 31149709Jacob KJ, Chevalier S, Lamarche M, Morais JA. Leucine Supplementation Does Not Alter Insulin Sensitivity in Prefrail and Frail Older Women following a Resistance Training Protocol. J Nutr. 2019 Jun 1;149(6):959-967. doi: 10.1093/jn/nxz038.
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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.
José A Morais, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leucine and Alanine in people with Frail Elderly, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in Canada.
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 11 inclusion and 7 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 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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 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?
Change from Baseline in Fractional Synthesis Rate (FSR) at 12 weeks (time frame: Baseline and at 12 weeks). 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 NCT01922167, which also lists 2 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 8 Mar 2019.