Citrulline, Exercise Training and Muscle Strength in the Elderly
Information source: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Elderly Patients
Intervention: Citrulline (Dietary Supplement); Non essential amino acid (Dietary Supplement)
Phase: N/A
Status: Completed
Sponsored by: Assistance Publique - Hôpitaux de Paris Official(s) and/or principal investigator(s): Christian Aussel, PHD, Study Director, Affiliation: Assistance Publique - Hôpitaux de Paris
Summary
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.
Clinical Details
Official title: "Effect of Citrulline Supplementation on Muscle Strength in Elderly Institutionalized Subjects Undergoing an Exercise Training Programme. "
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Primary outcome: Maximum strength of knee extensor muscles
Secondary outcome: Fat-free mass
Detailed description:
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.
Eligibility
Minimum age: 75 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
HOPITAL BICHAT Claude Bernard, Paris 75018, France
Additional Information
Starting date: March 2011
Last updated: March 6, 2015
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