Citrulline, Exercise Training and Muscle Strength in the Elderly

Study Overview
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Brief Summary
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The aim of this study is to assess the effect of citrulline supplementation on muscle strength in elderly institutionalized subjects undergoing a resistance exercise training program. The primary endpoint is the outcome of maximum strength of knee extensor muscles.

Detailed Description
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Maintaining muscle strength is mandatory for elderly persons to keep autonomy. Resistance exercise increases muscle strength in old and very old subjects, but there seems to be little effect on muscle mass. Citrulline is an amino acid that stimulates muscle protein synthesis, but its effect on muscle strength and mass remains to be determined. The aim of this study is to assess the effect of citrulline supplementation on muscle strength in elderly institutionalized subjects undergoing a resistance exercise training program. 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.

Official Title
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Effect of Citrulline Supplementation on Muscle Strength in Elderly Institutionalized Subjects Undergoing an Exercise Training Programme. 

Conditions
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Elderly Patients

Intervention / Treatment
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* Dietary Supplement: Citrulline
* Dietary Supplement: Non essential amino acid


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA: Aged over 75 years Able to walk at least 6 meters without human assistance. EXCLUSION CRITERIA: Moderate to severe cognitive disorders (MMSE < 20) 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

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Not essential amino acid<br>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. | Dietary Supplement: Non essential amino acid<br>* Non essential amino acid supplementation<br>* Other names: Non essential amino acid supplementation;|
| Experimental: Citrulline<br>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. | Dietary Supplement: Citrulline<br>* The subject will receive citrulline 10 g/day orally in the morning for 12 weeks.<br>* Other names: Dietary supplement Citrulline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum strength of knee extensor muscles | Strength testing will be repeated every two weeks for 12 weeks | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat-free mass | Fat-free mass was measured by DEXA | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Citrulline, protein-energy malnutrition, amino acids, muscle strength, resistance training