SARCO_COMM: Fish Protein Supplementation and Sarcopenia Outcomes in the Community
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Fish protein
|
Dietary Supplement: Intervention
12.5g (twice daily) Blue Whiting Protein Hydrolysates daily for 8 weeks
|
| Placebo Comparator: Control
|
Other: Control
Isocalorific Maltodextrin Citrus Flavoured Powder for 8 weeks
|
Outcome Measures
Primary Outcome Measures
- Lean weight [Change over 8 weeks]
Measured by Bio-Electrical Impedance Analysis
Secondary Outcome Measures
- Muscle strength [Change over 8 weeks]
Measured via hand grip dynamometry
- Mobility [Change over 8 weeks]
Assessed through 3 meter Timed up and go Test (time to walk 3 metre)
- Exercise tolerance [Change over 8 weeks]
Six minute walk test - distance travelled over 6 minutes
- Blood pressure [Change over 8 weeks]
Measured by a brachial blood pressure monitor
- Walking speed [Change over 8 weeks]
Assessed by the gait speed test in a 4-meter distance
- Functional fitness [Change over 8 weeks]
Assessed by time taken to perform five rises with arms crossed resting hands on their shoulders from seated.
- Lean weight [Change over 8 weeks]
Measured by DXA scanner (grams) (Ulster site only)
Other Outcome Measures
- Lipid profile [Change over 8 weeks]
Measured by Clinical Chemistry analyzer
- Vitamin D status [Change over 8 weeks]
Measured by LC-MS
- Inflammation [Change over 8 weeks]
Cytokine profile measured by ELISA
- Kidney function [Change over 8 weeks]
Measured by Clinical Chemistry analyzer
- Liver function [Change over 8 weeks]
Measured by Clinical Chemistry analyzer
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Free-living, apparently healthy older adults
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Able to fast from 10pm prior to the appointment
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Aged 50-70 years at recruitment
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Not regularly taking protein supplements
-
Free from serious musculoskeletal injury
Exclusion Criteria:
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Adults <50 years at recruitment
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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
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Cognitive impairment
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Exclusively receiving enteral or parenteral nutrition
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Currently taking any protein supplement
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Human Intervention Studies Unit, Ulster University / Physical Education and Sport Sciences, | Coleraine / Limerick | Co.Londonderry / Ireland | United Kingdom | BT52 1SA / V94 T9PX |
Sponsors and Collaborators
- University of Ulster
- University of Limerick
- Bio-Marine Ingredients Ireland
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21/EM/0140