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OpenTrials
Completed

NCT Number: NCT03429491

Novel Nutrition Solutions for Sarcopenia

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College Dublin

Dublin, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

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

Leucine-enriched protein

Dietary Supplement

Leucine-enriched whey protein

LC n-3 PUFA

Dietary Supplement

LC n-3 PUFA

Primary outcomes

  1. Appendicular skeletal muscle mass

    Time frame: 6 months

    Assessed via dual energy x-ray absorptiometry

Secondary outcomes

  1. Isometric knee extension strength

    Time frame: 6 months

    Maximal voluntary contraction

  2. Physical performance

    Time frame: 6 months

    Short physical performance battery, single leg stand, timed up and go

  3. Metabolomics

    Time frame: 6 months

    Assessed using nuclear magnetic resonance (NMR) spectroscopy

  4. Transcriptomics

    Time frame: 6 months

    Assessed via RNA Sequencing

  5. Thigh muscle mass

    Time frame: 6 months

    Assessed in dominant leg via MRI in sub cohort (n=39)

  6. Muscle protein synthesis

    Time frame: 6 months

    Measured as fractional synthetic rate (%/day) over a 3-d period at baseline and end of study

Sponsors and collaborators

Lead sponsor

University College Dublin

Other

Registry information

Official study title

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

Acronym: NUTRIMAL

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 12, 2018
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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