Clinical trial NCT03429491: Novel Nutrition Solutions for Sarcopenia
Official title: Novel Nutrition Solutions in Elderly at Risk of Sarcopenia: LC n-3 PUFA and Leucine Combinations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Lead sponsor: University College Dublin
Sponsor class: OTHER
First posted: 2018-02-12
Enrollment: 108
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Appendicular skeletal muscle mass
timeFrame: 6 months
Secondary outcomes:
measure: Isometric knee extension strength
timeFrame: 6 months
measure: Physical performance
timeFrame: 6 months
measure: Metabolomics
timeFrame: 6 months
measure: Transcriptomics
timeFrame: 6 months
measure: Thigh muscle mass
timeFrame: 6 months
measure: Muscle protein synthesis
timeFrame: 6 months
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: University College Dublin
Study officials:
affiliation: University College Dublin
name: Helen Roche, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.