Novel Nutrition Solutions for Sarcopenia

Not Applicable

Completed

• Conditions: Sarcopenia
• Interventions: Dietary Supplement: Leucine-enriched protein; Dietary Supplement: Placebo; Dietary Supplement: LC n-3 PUFA

• Registration Number: NCT03429491
• Lead Sponsor: University College Dublin

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.

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2018-02-03
• Study First Submitted QC: 2018-02-03
• Study First Posted: 2018-02-12
• Primary Completion: 2018-12-21
• Study Completion: 2018-12-21
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Leucine-enriched protein	Leucine-enriched protein	Juice based supplement containing leucine-enriched protein
Placebo	Placebo	Protein-free, LC n-3 PUFA-free juice based supplement
Leucine-enriched protein + LC n-3 PUFA	Leucine-enriched protein	Juice based supplement containing leucine-enriched protein and LC n-3 PUFA
Leucine-enriched protein + LC n-3 PUFA	LC n-3 PUFA	Juice based supplement containing leucine-enriched protein and LC n-3 PUFA

Primary Outcome Measures

Name	Time	Method
Appendicular skeletal muscle mass	6 months	Assessed via dual energy x-ray absorptiometry

Secondary Outcome Measures

Name	Time	Method
Thigh muscle mass	6 months	Assessed in dominant leg via MRI in sub cohort (n=39)
Muscle protein synthesis	6 months	Measured as fractional synthetic rate (%/day) over a 3-d period at baseline and end of study
Isometric knee extension strength	6 months	Maximal voluntary contraction
Physical performance	6 months	Short physical performance battery, single leg stand, timed up and go
Metabolomics	6 months	Assessed using nuclear magnetic resonance (NMR) spectroscopy
Transcriptomics	6 months	Assessed via RNA Sequencing

Trial Locations

Locations (1)

University College Dublin; 🇮🇪 Dublin, Ireland