Citrulline, Exercise Training and Muscle Strength in the Elderly

Not Applicable

Completed

• Conditions: Elderly Patients
• Interventions: Dietary Supplement: Non essential amino acid; Dietary Supplement: Citrulline

• Registration Number: NCT01599676
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2012-05-14
• Study First Submitted QC: 2012-05-15
• Study First Posted: 2012-05-16
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-31
• Last Update Posted: 2016-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Not essential amino acid	Non 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.
Citrulline	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.

Primary Outcome Measures

Name	Time	Method
Maximum strength of knee extensor muscles	12 weeks	Strength testing will be repeated every two weeks for 12 weeks

Secondary Outcome Measures

Name	Time	Method
Fat-free mass	12 weeks	Fat-free mass was measured by DEXA

Trial Locations

Locations (1)

HOPITAL BICHAT Claude Bernard; 🇫🇷 Paris, France