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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

Page last updated: August 23, 2015

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