Fish Protein Supplementation and Sarcopenia Outcomes in the Community

Study Overview
=================
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.

Official Title
-----------------
Blue Whiting Protein Hydrolysates and Sarcopenia Outcomes in Free-living, Community Dwelling Older Adults (SARCO_COMM).

Conditions
-----------------
Sarcopenia

Intervention / Treatment
-----------------
* Dietary Supplement: Intervention
* Other: Control


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel randomised control trial.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fish protein<br> | Dietary Supplement: Intervention<br>* 12.5g (twice daily) Blue Whiting Protein Hydrolysates daily for 8 weeks<br>|
| Placebo Comparator: Control<br> | Other: Control<br>* Isocalorific Maltodextrin Citrus Flavoured Powder for 8 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lean weight | Measured by Bio-Electrical Impedance Analysis | Change over 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength | Measured via hand grip dynamometry | Change over 8 weeks | 
| Mobility | Assessed through 3 meter Timed up and go Test (time to walk 3 metre) | Change over 8 weeks | 
| Exercise tolerance | Six minute walk test - distance travelled over 6 minutes | Change over 8 weeks | 
| Blood pressure | Measured by a brachial blood pressure monitor | Change over 8 weeks | 
| Walking speed | Assessed by the gait speed test in a 4-meter distance | Change over 8 weeks | 
| Functional fitness | Assessed by time taken to perform five rises with arms crossed resting hands on their shoulders from seated. | Change over 8 weeks | 
| Lean weight | Measured by DXA scanner (grams) (Ulster site only) | Change over 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sarcopenia, Fish protein, Fish hydrolysates, Protein supplementation, Older adults, Community, Muscle strength