AgeingNCT00929929
Study to Assess the Effect of Leucine Along With Resistance Exercise on Muscle Strength and Quality of Life in Elders
A study testing L-leucine., Maltodextrin. and Exercise program. in people with Ageing, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
The purpose of this study is to determine whether a nutritional supplement with an amino acid called leucine along with resistance exercise are effective in the improvement of muscle strength and quality of life in elderly people. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ageing
- What is being tested?
- L-leucine., Maltodextrin. and Exercise program.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2009to Jun 2013
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Over 70 years of age.
- Subjects capable of doing resistance exercise.
Who cannot join
- Hospitalized patients.
- Disabled patients (i.e., not being able to exercise).
- Patients that usually train in resistance exercise.
- Patients with chronic renal failure.
- Patients with a fractured extremity during the last 6 months.
- Patients that follow diets with a protein restriction.
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- Patients with oral nutritional support, enteral or parenteral nutrition.
- Patients in a low calorie diet to lose weight.
- Patients using pharmacological treatment with anorexigenic effects, anabolic steroids or corticosteroids.
- Patients with cognitive impairment or major psychiatric disorder.
- Non-signed informed consent.
- Any patient not capable to properly follow the treatment or not considered adequate by the researchers.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Nutrition and Dietetics Unit, Hospital Clínic de Barcelona
Barcelona, Catalonia, 08036
About this study
Official title: Randomized Double-blind, Placebo-controlled, Parallel Design, Pilot Study to Assess the Effect of a Nutritional Supplement With Leucine, Along With a Progressive Resistance Exercise Program, on Muscle Strength and Quality of Life in Elderly People.
The purpose of this study is to determine whether a nutritional supplement with an amino acid called leucine along with resistance exercise are effective in the improvement of muscle strength and quality of life in elderly people.
Read the detailed description
Physiological aging is accompanied by functional loss and changes in different organs, including the skeletal muscle, with a progressive reduction in muscle mass. This is called physiological sarcopenia of the elderly.
In any population of autonomous individuals over 65 years, a proportion between 3% and 32% depending on age, meets the criteria of the so-called Frailty Syndrome. Frailty is characterized by a decrease in reserves and resistance to aggression, conferring increased vulnerability, disability and poor vital prognosis.
A feature of the Frailty Syndrome is the potential reversibility of many of the elements at the initial stages of frailty. Currently, available treatment for frailty is limited. One of the tools should be the prevention of sarcopenia, where nutritional treatment and exercise have a vital role.
Protein synthesis in aged muscle can be improved by increasing leucine concentration above physiological levels by a higher intake. Regarding exercise, progressive resistance training is one of the interventions that have shown better results in the increase of mass and muscle strength in elderly people.
The hypothesis raises the possibility that an intervention consisting of a leucine supplement along with progressive resistance training, is superior to the same training program and a placebo in improving muscle strength and quality of life in elderly people.
- Conditions
- Ageing
- Being tested
- L-leucine., Maltodextrin., Exercise program.
- Keywords
- Aging, Functionality, Sarcopenia, Leucine, Progressive resistance exercise
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-leucine.Dietary supplement
Also called Leucine.
10 g of leucine per day, during 12 weeks.
Maltodextrin.Dietary supplement
Also called Maxijul.
10 g of maltodextrin per day, during 12 weeks.
Exercise program.Behavioural
Also called Resistance exercise.
Progressive resistance exercise program 4 days a week, during 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| L-Leucine | Experimental | This arm receives a supplement of leucine along with a progressive resistance exercise program. Receives: Dietary Supplement: L-leucine.; Behavioral: Exercise program. |
| Maltodextrin | Placebo comparator | This arm receives a supplement of maltodextrin along with a progressive resistance exercise program. Receives: Dietary Supplement: Maltodextrin.; Behavioral: Exercise program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength.
Measured: Baseline, 4 weeks, 12 weeks
Secondary outcomes (1)
Functionality
Measured: Baseline, 4 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgeingStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pere Leyes, Hospital Clinic of Barcelona
- Investigators
- Maria T Forga, MD, Principal investigator, Hospital Clinic of BarcelonaJoan Trabal, RD, MS, Study chair, Hospital Clinic of BarcelonaPere Leyes, MD, Study chair, Hospital Clinic of BarcelonaAndreu Farran, PhD, Study chair, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00929929
- Sponsor's protocol ID
- FRA_LEU-09
- Status last verified
- Oct 2014
- First submitted
- 29 Jun 2009
- Last updated
- 9 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
PubMed 11253156
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind, Placebo-controlled, Parallel Design, Pilot Study to Assess the Effect of a Nutritional Supplement With Leucine, Along With a Progressive Resistance Exercise Program, on Muscle Strength and Quality of Life in Elderly People.
- ClinicalTrials.gov ID
- NCT00929929
- Acronym / sponsor ID
- FRA_LEU-09
- Conditions
- Ageing
- Keywords
- Aging, Functionality, Sarcopenia, Leucine, Progressive resistance exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 30 Jun 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.
The purpose of this study is to determine whether a nutritional supplement with an amino acid called leucine along with resistance exercise are effective in the improvement of muscle strength and quality of life in elderly people.
Detailed description
Physiological aging is accompanied by functional loss and changes in different organs, including the skeletal muscle, with a progressive reduction in muscle mass. This is called physiological sarcopenia of the elderly.
In any population of autonomous individuals over 65 years, a proportion between 3% and 32% depending on age, meets the criteria of the so-called Frailty Syndrome. Frailty is characterized by a decrease in reserves and resistance to aggression, conferring increased vulnerability, disability and poor vital prognosis.
A feature of the Frailty Syndrome is the potential reversibility of many of the elements at the initial stages of frailty. Currently, available treatment for frailty is limited. One of the tools should be the prevention of sarcopenia, where nutritional treatment and exercise have a vital role.
Protein synthesis in aged muscle can be improved by increasing leucine concentration above physiological levels by a higher intake. Regarding exercise, progressive resistance training is one of the interventions that have shown better results in the increase of mass and muscle strength in elderly people.
The hypothesis raises the possibility that an intervention consisting of a leucine supplement along with progressive resistance training, is superior to the same training program and a placebo in improving muscle strength and quality of life in elderly people.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-Leucine | Experimental | Dietary Supplement: L-leucine., Behavioral: Exercise program.This arm receives a supplement of leucine along with a progressive resistance exercise program. |
| Maltodextrin | Placebo comparator | Dietary Supplement: Maltodextrin., Behavioral: Exercise program.This arm receives a supplement of maltodextrin along with a progressive resistance exercise program. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Over 70 years of age.
- Subjects capable of doing resistance exercise.
Key exclusion criteria (12 listed)
- Hospitalized patients.
- Disabled patients (i.e., not being able to exercise).
- Patients that usually train in resistance exercise.
- Patients with chronic renal failure.
- Patients with a fractured extremity during the last 6 months.
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 |
|---|---|---|
| L-leucine.Also: Leucine.10 g of leucine per day, during 12 weeks. | Dietary supplement | L-Leucine |
| Maltodextrin.Also: Maxijul.10 g of maltodextrin per day, during 12 weeks. | Dietary supplement | Maltodextrin |
| Exercise program.Also: Resistance exercise.Progressive resistance exercise program 4 days a week, during 12 weeks. | Behavioural | L-Leucine, Maltodextrin |
Primary outcome
Muscle strength.
Time frame: Baseline, 4 weeks, 12 weeks
1 secondary outcome
Functionality
Time frame: Baseline, 4 weeks, 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 9 Oct 2014.
- Background: PubMed 11253156Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
- A brief definition of the Frailty Syndrome.Link provided by the sponsor.
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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.
Maria T Forga, MD principal investigator
Hospital Clinic of Barcelona
Joan Trabal, RD, MS study chair
Hospital Clinic of Barcelona
Pere Leyes, MD study chair
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-leucine., Maltodextrin. and Exercise program. in people with Ageing, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 2 inclusion and 12 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 9 Oct 2014. 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 Spain. 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?
Muscle strength. (time frame: Baseline, 4 weeks, 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 NCT00929929, which also lists 1 linked publication.
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 9 Oct 2014.