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CompletedNCT03429491NUTRIMALUpdated Apr 18, 2019

Novel Nutrition Solutions for Sarcopenia

An interventional study of Placebo and Leucine-enriched protein in Sarcopenia, sponsored by University College Dublin. Completed at 1 site in Ireland. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-18.

Sponsored by University College Dublin · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Sarcopenia

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03

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
108 participants (actual)

Study arms

  • Placebo comparator
    Placebo

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

    Dietary Supplement: Placebo

  • Experimental
    Leucine-enriched protein

    Juice based supplement containing leucine-enriched protein

    Dietary Supplement: Leucine-enriched protein

  • Experimental
    Leucine-enriched protein + LC n-3 PUFA

    Juice based supplement containing leucine-enriched protein and LC n-3 PUFA

    Dietary Supplement: Leucine-enriched protein · Dietary Supplement: LC n-3 PUFA

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

05

What researchers measure

Primary outcomes

  1. Appendicular skeletal muscle mass

    Assessed via dual energy x-ray absorptiometry

    Time frame: 6 months

Secondary outcomes

  1. Isometric knee extension strength

    Maximal voluntary contraction

    Time frame: 6 months

  2. Physical performance

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

    Time frame: 6 months

  3. Metabolomics

    Assessed using nuclear magnetic resonance (NMR) spectroscopy

    Time frame: 6 months

  4. Transcriptomics

    Assessed via RNA Sequencing

    Time frame: 6 months

  5. Thigh muscle mass

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

    Time frame: 6 months

  6. Muscle protein synthesis

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

    Time frame: 6 months

06

Study locations

1 site
  • University College Dublin
    Dublin, Ireland
07

References and documents

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 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03429491
Lead sponsor
University College Dublin
Responsible party
Prof Helen M Roche (Professor Helen Roche, University College Dublin) — Principal investigator
First posted
Feb 12, 2018
Start date
Jun 1, 2017
Primary completion
Dec 21, 2018
Completion
Dec 21, 2018
Last update
Apr 18, 2019

Study contacts

Helen Roche, PhD
principal investigator · University College Dublin

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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