SarcopeniaNUTRIMALNCT03429491
Novel Nutrition Solutions for Sarcopenia
A study testing Leucine-enriched protein and LC n-3 PUFA in people with Sarcopenia, run by University College Dublin at 1 site in Ireland.
Trial summary
This study will examine the effect of leucine-enriched protein supplementation, alone and in combination with long chain n-3 polyunsaturated fatty acids (LC n-3 PUFA), on muscle mass and function in older adults at risk of sarcopenia. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Leucine-enriched protein and LC n-3 PUFA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteIreland
- Study dates
- 1 Jun 2017to 21 Dec 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age: ≥65 y
- Sex: males and females
- Low muscle mass (assessed via bioelectrical impedance analysis using cut-offs from Janssen, 2004) and/or low handgrip strength (< 30 kg men, <20kg women)
Who cannot join
- BMI >35 kg/m2
- Cancer - malignancy in the past 5 years
- Multiple Sclerosis, Parkinsons Disease
- Chronic kidney disease
- Liver failure
- Diabetes
Show all 17Show fewer
- Conditions that will affect ability to consume, digest and/or absorb the study drink (i.e. cows milk protein allergy, inflammatory bowel disease)
- Smokers
- Cognitive function < 21 on Mini-Mental State Examination
- Excess alcohol intake
- Regular resistance training
- Total walking incapacity
- Musculoskeletal or neuromuscular impairments that could interfere with strength testing
- Medications interfering with muscle metabolism
- Adherence to a high energy or high protein diet three months before starting and during the study. Use of protein containing or amino acid containing nutritional supplements three months before starting and during the study.
- High consumers of oily fish.
- Weight change > 3 kg past 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Nutrition Solutions in Elderly at Risk of Sarcopenia: LC n-3 PUFA and Leucine Combinations
This study will examine the effect of leucine-enriched protein supplementation, alone and in combination with long chain n-3 polyunsaturated fatty acids (LC n-3 PUFA), on muscle mass and function in older adults at risk of sarcopenia.
The investigators hypothesize that LC n-3 PUFA supplementation will further enhance the efficacy of the leucine-enriched protein.
Read the detailed description
The progressive loss of skeletal muscle mass and function with advancing age, termed sarcopenia, contributes substantially to disability, physical dependence, and mortality among older adults. Aging is associated with an attenuated muscle protein synthetic response to the ingestion of small to moderate protein doses compared to younger persons. Several studies have reported that the acute, postprandial muscle protein synthesis (MPS) response to a suboptimal protein dose is enhanced when the leucine content of the protein bolus is increased. This indicates that supplementing the lower-protein daily meals (i.e., breakfast and lunch) with leucine may represent a practical strategy to augment the MPS response to these meals and, subsequently, attenuate sarcopenic muscle mass loss over time. In addition, LC n-3 PUFA supplementation has been shown to enhance the MPS response to amino acid infusion older adults suggesting that combined leucine and LC n-3 PUFA supplementation be particularly effective for improving daily MPS, muscle mass and function in older adults.
- Conditions
- Sarcopenia
- Being tested
- Placebo, Leucine-enriched protein, LC n-3 PUFA
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Protein-free, LC n-3 PUFA-free juice based supplement
Leucine-enriched proteinDietary supplement
Leucine-enriched whey protein
LC n-3 PUFADietary supplement
LC n-3 PUFA
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Protein-free, LC n-3 PUFA-free juice based supplement Receives: Dietary Supplement: Placebo |
| Leucine-enriched protein | Experimental | Juice based supplement containing leucine-enriched protein Receives: Dietary Supplement: Leucine-enriched protein |
| Leucine-enriched protein + LC n-3 PUFA | Experimental | Juice based supplement containing leucine-enriched protein and LC n-3 PUFA Receives: Dietary Supplement: Leucine-enriched protein; Dietary Supplement: LC n-3 PUFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appendicular skeletal muscle mass
Assessed via dual energy x-ray absorptiometry
Measured: 6 months
Secondary outcomes (6)
Isometric knee extension strength
Maximal voluntary contraction
Measured: 6 months
Physical performance
Short physical performance battery, single leg stand, timed up and go
Measured: 6 months
Metabolomics
Assessed using nuclear magnetic resonance (NMR) spectroscopy
Measured: 6 months
Transcriptomics
Assessed via RNA Sequencing
Measured: 6 months
Thigh muscle mass
Assessed in dominant leg via MRI in sub cohort (n=39)
Measured: 6 months
Muscle protein synthesis
Measured as fractional synthetic rate (%/day) over a 3-d period at baseline and end of study
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start1 Jun 2017
- Primary completion21 Dec 2018
- Study completion21 Dec 2018
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 SarcopeniaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Helen M Roche, University College Dublin
- Investigators
- Helen Roche, PhD, Principal investigator, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429491
- Sponsor's protocol ID
- NUTRIMAL-3
- Other IDs
- 14/F/822
- Acronym
- NUTRIMAL
- Status last verified
- Apr 2019
- First submitted
- 3 Feb 2018
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Murphy CH, Flanagan EM, De Vito G, Susta D, Mitchelson KAJ, de Marco Castro E, Senden JMG, Goessens JPB, Miklosz A, Chabowski A, Segurado R, Corish CA, McCarthy SN, Egan B, van Loon LJC, Roche HM. Does supplementation with leucine-enriched protein alone and in combination with fish-oil-derived n-3 PUFA affect muscle mass, strength, physical performance, and muscle protein synthesis in well-nourished older adults? A randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2021 Jun 1;113(6):1411-1427. doi: 10.1093/ajcn/nqaa449.
PubMed 33871558
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Nutrition Solutions in Elderly at Risk of Sarcopenia: LC n-3 PUFA and Leucine Combinations
- ClinicalTrials.gov ID
- NCT03429491
- Acronym / sponsor ID
- NUTRIMAL / NUTRIMAL-3
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 12 Feb 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.
This study will examine the effect of leucine-enriched protein supplementation, alone and in combination with long chain n-3 polyunsaturated fatty acids (LC n-3 PUFA), on muscle mass and function in older adults at risk of sarcopenia.
The investigators hypothesize that LC n-3 PUFA supplementation will further enhance the efficacy of the leucine-enriched protein.
Detailed description
The progressive loss of skeletal muscle mass and function with advancing age, termed sarcopenia, contributes substantially to disability, physical dependence, and mortality among older adults. Aging is associated with an attenuated muscle protein synthetic response to the ingestion of small to moderate protein doses compared to younger persons. Several studies have reported that the acute, postprandial muscle protein synthesis (MPS) response to a suboptimal protein dose is enhanced when the leucine content of the protein bolus is increased. This indicates that supplementing the lower-protein daily meals (i.e., breakfast and lunch) with leucine may represent a practical strategy to augment the MPS response to these meals and, subsequently, attenuate sarcopenic muscle mass loss over time. In addition, LC n-3 PUFA supplementation has been shown to enhance the MPS response to amino acid infusion older adults suggesting that combined leucine and LC n-3 PUFA supplementation be particularly effective for improving daily MPS, muscle mass and function in older adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboProtein-free, LC n-3 PUFA-free juice based supplement |
| Leucine-enriched protein | Experimental | Dietary Supplement: Leucine-enriched proteinJuice based supplement containing leucine-enriched protein |
| Leucine-enriched protein + LC n-3 PUFA | Experimental | Dietary Supplement: Leucine-enriched protein, Dietary Supplement: LC n-3 PUFAJuice based supplement containing leucine-enriched protein and LC n-3 PUFA |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age: ≥65 y
- Sex: males and females
- Low muscle mass (assessed via bioelectrical impedance analysis using cut-offs from Janssen, 2004) and/or low handgrip strength (< 30 kg men, <20kg women)
Key exclusion criteria (17 listed)
- BMI >35 kg/m2
- Cancer - malignancy in the past 5 years
- Multiple Sclerosis, Parkinsons Disease
- Chronic kidney disease
- Liver failure
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 |
|---|---|---|
| PlaceboProtein-free, LC n-3 PUFA-free juice based supplement | Dietary supplement | Placebo |
| Leucine-enriched proteinLeucine-enriched whey protein | Dietary supplement | Leucine-enriched protein, Leucine-enriched protein + LC n-3 PUFA |
| LC n-3 PUFALC n-3 PUFA | Dietary supplement | Leucine-enriched protein + LC n-3 PUFA |
Primary outcome
Appendicular skeletal muscle mass
Time frame: 6 months
Assessed via dual energy x-ray absorptiometry
6 secondary outcomes
Isometric knee extension strength
Time frame: 6 months
Physical performance
Time frame: 6 months
Metabolomics
Time frame: 6 months
Transcriptomics
Time frame: 6 months
Thigh muscle mass
Time frame: 6 months
Muscle protein synthesis
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Derived from this study: PubMed 33871558Murphy CH, Flanagan EM, De Vito G, Susta D, Mitchelson KAJ, de Marco Castro E, Senden JMG, Goessens JPB, Miklosz A, Chabowski A, Segurado R, Corish CA, McCarthy SN, Egan B, van Loon LJC, Roche HM. Does supplementation with leucine-enriched protein alone and in combination with fish-oil-derived n-3 PUFA affect muscle mass, strength, physical performance, and muscle protein synthesis in well-nourished older adults? A randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2021 Jun 1;113(6):1411-1427. doi: 10.1093/ajcn/nqaa449.
- Individual participant dataSharing planned: No
Related trials for Sarcopenia
Not yet recruitingObservational study
Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
Malnutrition, Sarcopenia
Recruiting
Strength and Dual-Task on Sarcopenia in People With Parkinson's Disease
PARKINSON DISEASE (Disorder), Parkinsonism or Parkinson's Disease Nos
RecruitingObservational study
Investigating the Link Between Advanced Glycation End Products (AGEs) and Muscle Wasting in Sarcobesity
Sarcopenia, Obesity
Recruiting
Muscle Deterioration in Hospitalized Cancer Patient
Oncologic Diseases
Enrolling by invitation
Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia
Insomnia Chronic, Hypnotics and Sedatives
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.
Helen Roche, PhD principal investigator
University College Dublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leucine-enriched protein and LC n-3 PUFA in people with Sarcopenia, run by University College Dublin at 1 site in Ireland.
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 3 inclusion and 17 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: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Appendicular skeletal muscle mass (time frame: 6 months). 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 NCT03429491, 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 18 Apr 2019; AzTrials last refreshed its copy on 2 Nov 2026.