Fish Protein Supplementation and Sarcopenia Outcomes in the Community (SARCO_COMM)

Ulster University

Status

Unknown

Conditions

Sarcopenia

Treatments

Other: Control

Dietary Supplement: Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT05356559

21/EM/0140

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

50 to 70 years old

Volunteers

Accepts Healthy Volunteers

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