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Trial record 42 of 53 for:    HISTIDINE OR HISTIDINE MONOHYDROCHLORIDE

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

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ClinicalTrials.gov Identifier: NCT01599676
Recruitment Status : Completed
First Posted : May 16, 2012
Last Update Posted : August 2, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Elderly Patients Dietary Supplement: Citrulline Dietary Supplement: Non essential amino acid Not Applicable

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  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: "Effect of Citrulline Supplementation on Muscle Strength in Elderly Institutionalized Subjects Undergoing an Exercise Training Programme. "
Study Start Date : March 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Dietary supplement Citrulline




Primary Outcome Measures :
  1. Maximum strength of knee extensor muscles [ Time Frame: 12 weeks ]
    Strength testing will be repeated every two weeks for 12 weeks


Secondary Outcome Measures :
  1. Fat-free mass [ Time Frame: 12 weeks ]
    Fat-free mass was measured by DEXA



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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01599676


Locations
France
HOPITAL BICHAT Claude Bernard
Paris, France, 75018
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Study Director: Christian Aussel, PHD Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01599676     History of Changes
Other Study ID Numbers: AOM 09008
N° IDRCB: 2010-A002346-33 ( Other Grant/Funding Number: IDRCB: 2010-A002346-33 )
First Posted: May 16, 2012    Key Record Dates
Last Update Posted: August 2, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Citrulline
protein-energy malnutrition
amino acids
muscle strength
resistance training