Citrulline, Exercise Training and Muscle Strength in the... | NCT01599676

Studies
Citrulline, Exercise Training and Muscle Strength in the Elderly

NCT01599676

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Aug 2, 2016Estimated

Enrollment

91Actual

Phase

Not Applicable

Conditions

Elderly Patients

Interventions

Citrulline
Non essential amino acid

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
N° IDRCB: 2010-A002346-33	Other Grant/Funding Number	IDRCB: 2010-A002346-33

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

May 14, 2012

First Submission Date that Met QC Criteria

May 15, 2012

First Posted Date

May 16, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2016

Last Update Posted Date

Aug 2, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

91Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Not essential amino acid	Sham Comparator	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
Citrulline	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Citrulline	Dietary Supplement	The subject will receive citrulline 10 g/day orally in the morning for 12 weeks.	Citrulline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum strength of knee extensor muscles	Strength testing will be repeated every two weeks for 12 weeks	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Fat-free mass	Fat-free mass was measured by DEXA	12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

75 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christian Aussel, PHD	Assistance Publique - Hôpitaux de Paris	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
HOPITAL BICHAT Claude Bernard		Paris	Paris	75018	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011502	Protein-Energy Malnutrition

Ancestor Terms

ID	Term
D011488	Protein Deficiency
D003677	Deficiency Diseases
D044342	Malnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002956	Citrulline

Ancestor Terms

ID	Term
D000599	Amino Acids, Diamino
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided