NCT03429491

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 12, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2018

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

1.6 years

First QC Date

February 3, 2018

Last Update Submit

April 16, 2019

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

  • Appendicular skeletal muscle mass

    Assessed via dual energy x-ray absorptiometry

    6 months

Secondary Outcomes (6)

  • Isometric knee extension strength

    6 months

  • Physical performance

    6 months

  • Metabolomics

    6 months

  • Transcriptomics

    6 months

  • Thigh muscle mass

    6 months

  • +1 more secondary outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Leucine-enriched protein

EXPERIMENTAL

Juice based supplement containing leucine-enriched protein

Dietary Supplement: Leucine-enriched protein

Leucine-enriched protein + LC n-3 PUFA

EXPERIMENTAL

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

Dietary Supplement: Leucine-enriched proteinDietary Supplement: LC n-3 PUFA

Interventions

PlaceboDIETARY_SUPPLEMENT

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

Placebo
Leucine-enriched proteinDIETARY_SUPPLEMENT

Leucine-enriched whey protein

Leucine-enriched proteinLeucine-enriched protein + LC n-3 PUFA
LC n-3 PUFADIETARY_SUPPLEMENT

LC n-3 PUFA

Leucine-enriched protein + LC n-3 PUFA

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College Dublin

Dublin, Ireland

Location

Related Publications (1)

  • 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.

    PMID: 33871558DERIVED

MeSH Terms

Conditions

Sarcopenia

Interventions

P3H1 protein, human

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Helen Roche, PhD

    University College Dublin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Helen Roche

Study Record Dates

First Submitted

February 3, 2018

First Posted

February 12, 2018

Study Start

June 1, 2017

Primary Completion

December 21, 2018

Study Completion

December 21, 2018

Last Updated

April 18, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

IE(1)