search
Back to results

Novel Nutrition Solutions for Sarcopenia (NUTRIMAL)

Primary Purpose

Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Placebo
Leucine-enriched protein
LC n-3 PUFA
Sponsored by
University College Dublin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcopenia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University College Dublin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Leucine-enriched protein

Leucine-enriched protein + LC n-3 PUFA

Arm Description

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

Juice based supplement containing leucine-enriched protein

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

Outcomes

Primary Outcome Measures

Appendicular skeletal muscle mass
Assessed via dual energy x-ray absorptiometry

Secondary Outcome Measures

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

Full Information

First Posted
February 3, 2018
Last Updated
April 16, 2019
Sponsor
University College Dublin
search

1. Study Identification

Unique Protocol Identification Number
NCT03429491
Brief Title
Novel Nutrition Solutions for Sarcopenia
Acronym
NUTRIMAL
Official Title
Novel Nutrition Solutions in Elderly at Risk of Sarcopenia: LC n-3 PUFA and Leucine Combinations
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
December 21, 2018 (Actual)
Study Completion Date
December 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Dublin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Protein-free, LC n-3 PUFA-free juice based supplement
Arm Title
Leucine-enriched protein
Arm Type
Experimental
Arm Description
Juice based supplement containing leucine-enriched protein
Arm Title
Leucine-enriched protein + LC n-3 PUFA
Arm Type
Experimental
Arm Description
Juice based supplement containing leucine-enriched protein and LC n-3 PUFA
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Protein-free, LC n-3 PUFA-free juice based supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Leucine-enriched protein
Intervention Description
Leucine-enriched whey protein
Intervention Type
Dietary Supplement
Intervention Name(s)
LC n-3 PUFA
Intervention Description
LC n-3 PUFA
Primary Outcome Measure Information:
Title
Appendicular skeletal muscle mass
Description
Assessed via dual energy x-ray absorptiometry
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Isometric knee extension strength
Description
Maximal voluntary contraction
Time Frame
6 months
Title
Physical performance
Description
Short physical performance battery, single leg stand, timed up and go
Time Frame
6 months
Title
Metabolomics
Description
Assessed using nuclear magnetic resonance (NMR) spectroscopy
Time Frame
6 months
Title
Transcriptomics
Description
Assessed via RNA Sequencing
Time Frame
6 months
Title
Thigh muscle mass
Description
Assessed in dominant leg via MRI in sub cohort (n=39)
Time Frame
6 months
Title
Muscle protein synthesis
Description
Measured as fractional synthetic rate (%/day) over a 3-d period at baseline and end of study
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Roche, PhD
Organizational Affiliation
University College Dublin
Official's Role
Principal Investigator
Facility Information:
Facility Name
University College Dublin
City
Dublin
Country
Ireland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33871558
Citation
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.
Results Reference
derived

Learn more about this trial

Novel Nutrition Solutions for Sarcopenia

We'll reach out to this number within 24 hrs