Novel Nutrition Solutions for Sarcopenia

Sarcopenia Clinical Trial

— NUTRIMAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03429491
• Other study ID #: NUTRIMAL-3
• Secondary ID: 14/F/822
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: December 21, 2018

Study information

• Verified date: April 2019
• Source: University College Dublin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

The investigators hypothesize that LC n-3 PUFA supplementation will further enhance the efficacy of the leucine-enriched protein.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: December 21, 2018
• Est. primary completion date: December 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Dietary Supplement:
• Placebo
Protein-free, LC n-3 PUFA-free juice based supplement
• Leucine-enriched protein
Leucine-enriched whey protein
• LC n-3 PUFA
LC n-3 PUFA

Locations

Country	Name	City	State
Ireland	University College Dublin	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
University College Dublin

Country where clinical trial is conducted

Ireland, 

Outcome

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