Fish Protein Supplementation and Sarcopenia Outcomes in the Community
NCT ID: NCT05356559
Last Updated: 2022-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2022-04-25
2023-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Fish protein
Intervention
12.5g (twice daily) Blue Whiting Protein Hydrolysates daily for 8 weeks
Control
Control
Isocalorific Maltodextrin Citrus Flavoured Powder for 8 weeks
Interventions
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Intervention
12.5g (twice daily) Blue Whiting Protein Hydrolysates daily for 8 weeks
Control
Isocalorific Maltodextrin Citrus Flavoured Powder for 8 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
70 Years
ALL
Yes
Sponsors
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University of Limerick
OTHER
Bio-Marine Ingredients Ireland
UNKNOWN
University of Ulster
OTHER
Responsible Party
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Locations
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Human Intervention Studies Unit, Ulster University / Physical Education and Sport Sciences,
Coleraine / Limerick, Co.Londonderry / Ireland, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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21/EM/0140
Identifier Type: -
Identifier Source: org_study_id
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