Citrulline, Exercise Training and Muscle Strength in the Elderly (CITREX)

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

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.

Study Overview

• Status: Completed
• Conditions: Elderly Patients
• Intervention / Treatment: Dietary supplement: Non essential amino acid; Dietary supplement: Citrulline

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 Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75018
    • Hopital Bichat Claude Bernard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 73 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: 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.	Dietary supplement: Non essential amino acid; Non essential amino acid supplementation; Other Names: Non essential amino acid supplementation
Experimental: 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.	Dietary supplement: Citrulline; The subject will receive citrulline 10 g/day orally in the morning for 12 weeks.; Other Names: Dietary supplement Citrulline

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Director: Christian Aussel, PHD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: May 14, 2012
• First Submitted That Met QC Criteria: May 15, 2012
• First Posted (Estimate): May 16, 2012

Study Record Updates

• Last Update Posted (Estimate): August 2, 2016
• Last Update Submitted That Met QC Criteria: July 31, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: muscle strength; resistance training; Citrulline; amino acids; protein-energy malnutrition
• Other Study ID Numbers: AOM 09008; N° IDRCB: 2010-A002346-33 (Other Grant/Funding Number: IDRCB: 2010-A002346-33)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided