Citrulline, Exercise Training and Muscle Strength in the Elderly
NCT ID: NCT01599676
Last Updated: 2016-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
91 participants
INTERVENTIONAL
2011-03-31
2014-12-31
Brief Summary
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Detailed Description
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All the subjects (84) will undergo a resistance exercise training program for 12 weeks. The subjects will have a regimen of high-intensity progressive resistance training of the knee extensors 3 days per week. These muscle groups were chosen because of their importance in functional activities. The subjects will be randomized into two groups. An intervention group will receive orally citrulline at 10 g/day, and a control group will receive an isonitrogenous amount of nonessential amino acids (alanine, aspartate, glycine, serine, histidine and proline in equimolar quantity). During the 12 weeks of supplementation, clinical tolerance will be evaluated. Strength testing will be repeated every two weeks for 12 weeks. The primary endpoint is the outcome of maximum strength of knee extensor muscles. Fat-free mass (DEXA), gait velocity, timed get up and go, spontaneous physical activity (activity monitors), nutritional status (weight, albuminemia, TRANSTHYRETINEMIA) and quality of life will be measured at inclusion and at the end of the study. The number of falls during the study will be recorded.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Not essential amino acid
Non essential amino acid:
The subjects will have a regimen of high-intensity progressive resistance training of the knee extensors 3 days per week for 12 weeks. The subjects will receive 1 unit of an equivalent quantity of nonessential amino acids (alanine, aspartate, glycine, serine, histidine and proline in equimolar quantity) isonitrogenous to 10 g of citrulline, once in the morning for 12 weeks.
Non essential amino acid
Non essential amino acid supplementation
Citrulline
The subjects will have a regimen of high-intensity progressive resistance training of the knee extensors 3 days per week for 12 weeks. The subjects will receive citrulline 10 g/day orally in the morning for 12 weeks.
Citrulline
The subject will receive citrulline 10 g/day orally in the morning for 12 weeks.
Interventions
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Citrulline
The subject will receive citrulline 10 g/day orally in the morning for 12 weeks.
Non essential amino acid
Non essential amino acid supplementation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to walk at least 6 meters without human assistance.
Exclusion Criteria
* Severe malnutrition (BMI \< 18 or weight loss \> 10 % in 1 month or \> 15 % in 6 months, or albuminemia \< 30 g/L),
* Inflammation (CRP \> 30 mg/L),
* Severe renal failure (creatinine clearance \< 30 mL/mn),
* Stage 4 cardiac failure,
* Respiratory failure,
* Corticoid treatment,
* Participation in another trial
75 Years
ALL
Yes
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Christian Aussel, PHD
Role: STUDY_DIRECTOR
Assistance Publique - Hôpitaux de Paris
Locations
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HOPITAL BICHAT Claude Bernard
Paris, Paris, France
Countries
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Other Identifiers
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N° IDRCB: 2010-A002346-33
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
AOM 09008
Identifier Type: -
Identifier Source: org_study_id
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