Citrulline, Exercise Training and Muscle Strength in the Elderly

NCT01599676 | Completed DMC

• 2 other identifiers: AOM 09008N° IDRCB: 2010-A002346-33
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Elderly Patients

Keywords

Citrulline; protein-energy malnutrition; amino acids; muscle strength; resistance training

Outcome Measures

Primary Outcomes (1)

• Maximum strength of knee extensor muscles

  Strength testing will be repeated every two weeks for 12 weeks

  12 weeks

Secondary Outcomes (1)

• Fat-free mass

  12 weeks

Study Arms (2)

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

Citrulline DIETARY_SUPPLEMENT

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

Also known as: Dietary supplement Citrulline

Citrulline

Non essential amino acid DIETARY_SUPPLEMENT

Non essential amino acid supplementation

Also known as: Non essential amino acid supplementation

Not essential amino acid

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Aged over 75 years
• Able to walk at least 6 meters without human assistance.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

HOPITAL BICHAT Claude Bernard

Paris, Paris, 75018, France

Location

MeSH Terms

Conditions

Protein-Energy Malnutrition

Interventions

Citrulline

Condition Hierarchy (Ancestors)

Protein Deficiency; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Diamino; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Christian Aussel, PHD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2012
• First Posted: May 16, 2012
• Study Start: March 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 2, 2016

Record last verified: 2016-07

Locations

FR (1)