Citrulline, Exercise Training and Muscle Strength in the Elderly

Elderly Patients Clinical Trial

— CITREX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01599676
• Other study ID #: AOM 09008
• Secondary ID: N° IDRCB: 2010-A
• Status: Completed
• Phase: N/A
• First received: May 14, 2012
• Last updated: July 31, 2016
• Start date: March 2011
• Est. completion date: December 2014

Study information

• Verified date: July 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 75 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Elderly Patients

Intervention

Dietary Supplement:
• Citrulline
The subject will receive citrulline 10 g/day orally in the morning for 12 weeks.
• Non essential amino acid
Non essential amino acid supplementation

Locations

Country	Name	City	State
France	HOPITAL BICHAT Claude Bernard	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum strength of knee extensor muscles	Strength testing will be repeated every two weeks for 12 weeks	12 weeks	No
Secondary	Fat-free mass	Fat-free mass was measured by DEXA	12 weeks	No