10-week Leucine Supplementation in Cerebral Palsy | NCT03668548

Studies
10-week Leucine Supplementation in Cerebral Palsy

NCT03668548

Sponsor

St Mary's University College

Status

Unknown status

Last Update Posted

Sep 12, 2018Actual

Enrollment

25Actual

Phase

Not Applicable

Conditions

Cerebral Palsy
Cerebral Palsy, Mixed
Cerebral Palsy Ataxic

Interventions

Leucine
Placebo

Countries

United Kingdom

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

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 20, 2018Actual

Primary Completion Date

Oct 22, 2018Estimated

Completion Date

Oct 22, 2018Estimated

First Submitted Date

Aug 20, 2018

First Submission Date that Met QC Criteria

Sep 11, 2018

First Posted Date

Sep 12, 2018Actual

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

Sep 11, 2018

Last Update Posted Date

Sep 12, 2018Actual

Name	Class
University of Gloucestershire	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to assess the effects of 10-weeks leucine supplementation on muscle growth, metabolism, body composition, inflammation and wellbeing in adolescents and young adults with CP.

Detailed Description

Cerebral palsy (CP) is caused by damage to the developing brain and descending pathways, leading to altered patterns of growth and development. Those with CP may encounter early symptoms of paresis and spasticity, leading to progressive secondary musculoskeletal complications, including increased muscle atrophy and abnormal growth of contractile and non-contractile tissue. This causes significant weakness of the muscle and compromises daily motor function, leading to substantial declines in activities of daily living and independence. As such, interventions aimed at increasing muscle mass or preventing muscle atrophy for those with CP must be established. It is well established that dietary protein ingestion stimulates protein synthesis and inhibits proteolytic pathways, resulting in a positive protein balance and net muscle mass gain. In particular, leucine (a branched chain amino acid; BCAA), has been used to facilitate protein synthesis and muscle growth. Leucine also has anti-inflammatory roles, some of which are central in origin and have been shown to effect mood and features of wellbeing. However, there has been no investigation of the effects of leucine supplementation on any of these parameters in CP. Therefore, the purpose of this study is to assess the effects of 10-weeks leucine supplementation on muscle growth, metabolism, body composition, inflammation and wellbeing in adolescents and young adults with CP.

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

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Leucine group	Experimental	To receive leucine on a daily basis for 10 weeks	Dietary Supplement: Leucine
Control group	Placebo Comparator	To receive a placebo supplement on a daily basis for 10 weeks	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Leucine	Dietary Supplement	192 mg/kg body mass/day	Leucine group	Amino Acid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Skeletal muscle volume	Change in biceps brachii volume	10 weeks

Secondary Outcomes

Measure	Description	Time Frame
Resting metabolic rate	Change in resting energy expenditure and substrate metabolism	10 weeks
Perceptual well-being questionnaire	Change in a composite measure of five different wellbeing sub-components

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A diagnosis of spastic cerebral palsy
Aged 12-22 years

Exclusion Criteria:

Orthopaedic surgery of the upper-limbs in the past 12 months
Botulinum toxin type A injections in the past 6 months
Serial casting in the past 6 months
Insufficient cognitive understanding to comply with the assessment procedures and intervention
Liver and/or kidney dysfunction

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nicola Theis, PhD	University of Gloucestershire	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Gloucestershire		Cheltenham	Gloucestershire	GL502RH	United Kingdom
St Marys Umiversity College

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31965179	Derived	Theis N, Brown MA, Wood P, Waldron M. Leucine Supplementation Increases Muscle Strength and Volume, Reduces Inflammation, and Affects Wellbeing in Adults and Adolescents with Cerebral Palsy. J Nutr. 2021 Jan 4;151(1):59-64. doi: 10.1093/jn/nxaa006.

ID	Term
D002547	Cerebral Palsy
C562856	Cerebral Palsy, Ataxic, Autosomal Recessive

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D007930	Leucine
D000596	Amino Acids

ID	Term
D000597	Amino Acids, Branched-Chain
D000602	Amino Acids, Peptides, and Proteins
D000601	Amino Acids, Essential