Cerebral PalsyNCT03668548
10-week Leucine Supplementation in Cerebral Palsy
A study testing Leucine in people with Cerebral Palsy and Cerebral Palsy, Mixed, run by St Mary's University College at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 40 years
- Conditions the study is for
- Cerebral Palsy, Cerebral Palsy, Mixed, Cerebral Palsy Ataxic
- What is being tested?
- Leucine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 20 Aug 2018to 22 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- A diagnosis of spastic cerebral palsy
- Aged 12-22 years
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University of Gloucestershire
Cheltenham, Gloucestershire, GL502RH
St Marys Umiversity College
London, TW1 4SX
About this study
Official title: The Effects of 10-week Leucine Supplementation on Muscle Growth, Body Composition, Metabolism, Inflammation and Wellbeing of Adolescents and Young Adults With Cerebral Palsy
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.
Read the 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.
- Conditions
- Cerebral Palsy, Cerebral Palsy, Mixed, Cerebral Palsy Ataxic
- Being tested
- Leucine, Placebo
- Medical subject headings
- Cerebral Palsy, Cerebral Palsy, Ataxic, Autosomal Recessive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeucineDietary supplement
Also called Amino Acid
192 mg/kg body mass/day
PlaceboDietary supplement
A taste and calorie-matched placebo
| Study group | Role | What they receive |
|---|---|---|
| Leucine group | Experimental | To receive leucine on a daily basis for 10 weeks Receives: Dietary Supplement: Leucine |
| Control group | Placebo comparator | To receive a placebo supplement on a daily basis for 10 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal muscle volume
Change in biceps brachii volume
Measured: 10 weeks
Secondary outcomes (4)
Resting metabolic rate
Change in resting energy expenditure and substrate metabolism
Measured: 10 weeks
Perceptual well-being questionnaire
Change in a composite measure of five different wellbeing sub-components
Measured: 10 weeks
Systemic inflammation (C-Reactive protein; C-RP)
Change in C-RP
Measured: 10 weeks
Skeletal muscle strength
Change in the biceps brachii force production
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start20 Aug 2018
- Primary completion22 Oct 2018 (estimated)
- Study completion22 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be a randomised controlled pilot trial. Participants will complete testing at baseline and after 10 weeks.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Mary's University College
- Sponsor type
- University, hospital or other
- Collaborators
- University of Gloucestershire
- Responsible party
- Sponsor
- Investigators
- Nicola Theis, PhD, Principal investigator, University of Gloucestershire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668548
- Sponsor's protocol ID
- REC.18.85.7
- Status last verified
- Aug 2018
- First submitted
- 20 Aug 2018
- Last updated
- 12 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31965179
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of 10-week Leucine Supplementation on Muscle Growth, Body Composition, Metabolism, Inflammation and Wellbeing of Adolescents and Young Adults With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03668548
- Acronym / sponsor ID
- REC.18.85.7
- Conditions
- Cerebral Palsy, Cerebral Palsy, Mixed, Cerebral Palsy Ataxic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (actual)
- Lead sponsor
- St Mary's University CollegeUniversity, hospital or other
- Collaborators
- University of Gloucestershire
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 22 Oct 2018 (estimated)
- Study completion
- 22 Oct 2018 (estimated)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study will be a randomised controlled pilot trial. Participants will complete testing at baseline and after 10 weeks.
| Arm | Type | Receives |
|---|---|---|
| Leucine group | Experimental | Dietary Supplement: LeucineTo receive leucine on a daily basis for 10 weeks |
| Control group | Placebo comparator | Dietary Supplement: PlaceboTo receive a placebo supplement on a daily basis for 10 weeks |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- A diagnosis of spastic cerebral palsy
- Aged 12-22 years
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LeucineAlso: Amino Acid192 mg/kg body mass/day | Dietary supplement | Leucine group |
| PlaceboA taste and calorie-matched placebo | Dietary supplement | Control group |
Primary outcome
Skeletal muscle volume
Time frame: 10 weeks
Change in biceps brachii volume
4 secondary outcomes
Resting metabolic rate
Time frame: 10 weeks
Perceptual well-being questionnaire
Time frame: 10 weeks
Systemic inflammation (C-Reactive protein; C-RP)
Time frame: 10 weeks
Skeletal muscle strength
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
- Derived from this study: PubMed 31965179Theis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicola Theis, PhD principal investigator
University of Gloucestershire
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leucine in people with Cerebral Palsy and Cerebral Palsy, Mixed, run by St Mary's University College at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal muscle volume (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03668548, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2018.