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Novel Nutrition Solutions for Sarcopenia

Novel Nutrition Solutions in Elderly at Risk of Sarcopenia: LC n-3 PUFA and Leucine Combinations

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03429491
Acronym
NUTRIMAL
Enrollment
108
Registered
2018-02-12
Start date
2017-06-01
Completion date
2018-12-21
Last updated
2019-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcopenia

Brief 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. 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.

Interventions

DIETARY_SUPPLEMENTPlacebo

Protein-free, LC n-3 PUFA-free juice based supplement

DIETARY_SUPPLEMENTLeucine-enriched protein

Leucine-enriched whey protein

DIETARY_SUPPLEMENTLC n-3 PUFA

LC n-3 PUFA

Sponsors

University College Dublin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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)

Exclusion criteria

* BMI \>35 kg/m2 * Cancer - malignancy in the past 5 years * Multiple Sclerosis, Parkinsons Disease * Chronic kidney disease * Liver failure * Diabetes * 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

Design outcomes

Primary

MeasureTime frameDescription
Appendicular skeletal muscle mass6 monthsAssessed via dual energy x-ray absorptiometry

Secondary

MeasureTime frameDescription
Physical performance6 monthsShort physical performance battery, single leg stand, timed up and go
Metabolomics6 monthsAssessed using nuclear magnetic resonance (NMR) spectroscopy
Isometric knee extension strength6 monthsMaximal voluntary contraction
Thigh muscle mass6 monthsAssessed in dominant leg via MRI in sub cohort (n=39)
Muscle protein synthesis6 monthsMeasured as fractional synthetic rate (%/day) over a 3-d period at baseline and end of study
Transcriptomics6 monthsAssessed via RNA Sequencing

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026