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Completed

NCT Number: NCT01599676

Citrulline, Exercise Training and Muscle Strength in the Elderly

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.

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Key information

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HOPITAL BICHAT Claude Bernard

Paris, 75018, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Citrulline

Dietary Supplement

The subject will receive citrulline 10 g/day orally in the morning for 12 weeks.

Other names: Dietary supplement Citrulline

Non essential amino acid

Dietary Supplement

Non essential amino acid supplementation

Other names: Non essential amino acid supplementation

Primary outcomes

  1. Maximum strength of knee extensor muscles

    Time frame: 12 weeks

    Strength testing will be repeated every two weeks for 12 weeks

Secondary outcomes

  1. Fat-free mass

    Time frame: 12 weeks

    Fat-free mass was measured by DEXA

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: CITREX

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
May 16, 2012
Registry last updated
Aug 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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