Clinical trial NCT05356559: Fish Protein Supplementation and Sarcopenia Outcomes in the Community
Official title: Blue Whiting Protein Hydrolysates and Sarcopenia Outcomes in Free-living, Community Dwelling Older Adults (SARCO_COMM).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sarcopenia
Keywords: Sarcopenia
Fish protein
Fish hydrolysates
Protein supplementation
Older adults
Community
Muscle strength
Lead sponsor: University of Ulster
Sponsor class: OTHER
Collaborators: name: University of Limerick
name: Bio-Marine Ingredients Ireland
First posted: 2022-05-02
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel randomised control trial.
Primary purpose: PREVENTION

Brief summary: Sarcopenia is a progressive and generalised skeletal muscle disorder involving the accelerated loss of muscle mass and function that is associated with increase adverse outcomes including falls, functional decline, frailty and mortality. Diet, specifically protein has been proposed to have a role in the prevention and treatment of muscle loss in the older adult population nevertheless there is paucity of research on the effect of protein supplementation on lean body mass and other clinical outcomes in older adults.

This 2-arm parallel, double-blind, randomised, controlled dietary supplement human intervention study aims to investigate the effect of consuming 12.5g (twice daily) Blue Whiting Protein Hydrolysates daily in combination with exercise for 8 weeks on whole body lean mass tissue and measures of muscle strength and functionality in free living community dwelling older adults.

Participants (N150; 75/site (Ulster \& Limerick); 75/group; 50-70 years) will be stratified by age, gender and BMI and randomly allocated to consume two sachets of either the Blue Whiting Protein Hydrolysates powder daily (12.5g at breakfast and lunch (Total 25g)), (mixed with an everyday food / drink product (provided by Ulster University) or an isocalorific maltodextrin citrus flavoured powder (Control) (mixed with an everyday food / drink product).

Assessments to be undertaken pre and post intervention include; body composition including lean tissue mass measured by DXA whole body scan (Ulster site only), Bio-Electrical Impedance Analysis (BIA), hand grip strength, a 'timed get up and go' test, 6 minute walk test, gait speed test, chair stand test, blood pressure measurements, a quality of life questionnaire, a health and lifestyle questionnaire and a physical activity questionnaire. A trained phlebotomist will obtain a 40ml max blood sample from each participant pre and post intervention. Blood samples will be used to measure markers associated with sarcopenia (serum 25(OH)D, pro inflammatory cytokine profile, full lipid profiles and kidney and liver profiles). A 4-day food diary will be collected at baseline only to determine habitual protein intake. At post intervention only, bone mineral density at the spine and hip will be measured by a DXA scanner.

Comparisons will be made (ANCOVA) between the intervention group and control group over time.


Eligibility criteria: Inclusion Criteria:

* Free-living, apparently healthy older adults
* Able to fast from 10pm prior to the appointment
* Aged 50-70 years at recruitment
* Not regularly taking protein supplements
* Free from serious musculoskeletal injury

Exclusion Criteria:

* Adults \<50 years at recruitment
* Food allergy or intolerance that would prevent consumption of fish
* Diagnosed with any form of terminal disease or past medical history of conditions or medications that may interfere with supplementation and/or study outcomes, such as diabetes, kidney, digestive, thyroidal disease
* Cognitive impairment
* Exclusively receiving enteral or parenteral nutrition
* Currently taking any protein supplement
* Undertaking resistance exercise regularly
* Planning to lose weight/go on a special diet
* Any conditions/anomalies that could potentially interfere with the DXA
* Been advised not to undertake physical activity

Primary outcomes:
measure: Lean weight
timeFrame: Change over 8 weeks
Secondary outcomes:
measure: Muscle strength
timeFrame: Change over 8 weeks
measure: Mobility
timeFrame: Change over 8 weeks
measure: Exercise tolerance
timeFrame: Change over 8 weeks
measure: Blood pressure
timeFrame: Change over 8 weeks
measure: Walking speed
timeFrame: Change over 8 weeks
measure: Functional fitness
timeFrame: Change over 8 weeks
measure: Lean weight
timeFrame: Change over 8 weeks
Other outcomes:
measure: Lipid profile
timeFrame: Change over 8 weeks
measure: Vitamin D status
timeFrame: Change over 8 weeks
measure: Inflammation
timeFrame: Change over 8 weeks
measure: Kidney function
timeFrame: Change over 8 weeks
measure: Liver function
timeFrame: Change over 8 weeks
Locations:
city: Coleraine / Limerick
country: United Kingdom
facility: Human Intervention Studies Unit, Ulster University / Physical Education and Sport Sciences,
state: Co.Londonderry / Ireland
Study officials:
References: