Citrulline, Exercise Training and Muscle Strength in the Elderly

NCT ID: NCT01599676

Last Updated: 2016-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Elderly Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type SHAM_COMPARATOR

Non essential amino acid

Intervention Type DIETARY_SUPPLEMENT

Non essential amino acid supplementation

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.

Group Type EXPERIMENTAL

Citrulline

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Citrulline

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

Intervention Type DIETARY_SUPPLEMENT

Non essential amino acid

Non essential amino acid supplementation

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Dietary supplement Citrulline Non essential amino acid supplementation

Eligibility Criteria

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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
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christian Aussel, PHD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

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HOPITAL BICHAT Claude Bernard

Paris, Paris, France

Site Status

Countries

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France

Other Identifiers

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N° IDRCB: 2010-A002346-33

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AOM 09008

Identifier Type: -

Identifier Source: org_study_id

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