Novel Nutrition Solutions for Sarcopenia

NCT ID: NCT03429491

Last Updated: 2019-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2018-12-21

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.

Conditions

Sarcopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Leucine-enriched protein

Juice based supplement containing leucine-enriched protein

Group Type: EXPERIMENTAL

Leucine-enriched protein

Intervention Type: DIETARY_SUPPLEMENT

Leucine-enriched whey protein

Leucine-enriched protein + LC n-3 PUFA

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

Group Type: EXPERIMENTAL

Leucine-enriched protein

Intervention Type: DIETARY_SUPPLEMENT

Leucine-enriched whey protein

LC n-3 PUFA

Intervention Type: DIETARY_SUPPLEMENT

LC n-3 PUFA

Interventions

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Leucine-enriched protein

Leucine-enriched whey protein

Intervention Type: DIETARY_SUPPLEMENT

LC n-3 PUFA

LC n-3 PUFA

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University College Dublin

OTHER

Sponsor Role: lead

Responsible Party

Prof Helen M Roche

Professor Helen Roche

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helen Roche, PhD

Role: PRINCIPAL_INVESTIGATOR

University College Dublin

Locations

University College Dublin

Dublin, , Ireland

Countries

Ireland

References

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.

Reference Type: DERIVED

PMID: 33871558 (View on PubMed)

Other Identifiers

14/F/822

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NUTRIMAL-3

Identifier Type: -

Identifier Source: org_study_id