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Fish Protein Supplementation and Sarcopenia Outcomes in Carehomes (SARCO_CARE)

Primary Purpose

Sarcopenia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Blue Whiting Protein Hydrolysate
Placebo
Sponsored by
University of Ulster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcopenia focused on measuring Sarcopenia, Fish protein, Fish hydrolysates, Protein supplementation, Older adults, Community, Muscle strength

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Individuals residing in a residential care facility Willing to participate in the study Without major cognitive impairment Not regularly taking protein supplements Not at end-of-life stage Exclusion Criteria: At end-of-life stage. Major cognitive impairment Exclusively receiving enteral or parenteral nutrition Food allergy or intolerance that would prevent consumption of the study supplement (e.g. fish) Currently taking any protein supplement

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Fish protein supplement

    Placebo

    Arm Description

    Blue Whiting Protein Hydrolysate

    Isocalorific Maltodextrin Citrus Flavoured Powder

    Outcomes

    Primary Outcome Measures

    Lean mass
    Assessed via Tanita body composition monitor

    Secondary Outcome Measures

    Muscle strength
    Measured via hand grip dynamometry
    Muscle functionality
    Measured via hand grip dynamometry
    Mobility
    Assessed through timed get up and go test (time to walk 3 metres)
    Mobility
    Assessed through chair stand test

    Full Information

    First Posted
    November 21, 2022
    Last Updated
    December 1, 2022
    Sponsor
    University of Ulster
    Collaborators
    University of Limerick, Bio-Marine Ingredients Ireland
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05637450
    Brief Title
    Fish Protein Supplementation and Sarcopenia Outcomes in Carehomes
    Acronym
    SARCO_CARE
    Official Title
    Blue Whiting Protein Hydrolysates and Sarcopenia Outcomes in Older Adults Residing in Residential Care Facilities (SARCO_CARE)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    August 31, 2023 (Anticipated)
    Study Completion Date
    August 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Ulster
    Collaborators
    University of Limerick, Bio-Marine Ingredients Ireland

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The proposed study aims to investigate the effect of consuming 12.5g (twice daily) Blue Whiting Protein Hydrolysates (BWPH) daily for 6 weeks on whole body lean mass tissue and measures of muscle strength and functionality in older adults residing in residential care facilities.
    Detailed Description
    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, and especially those in residential care where the prevalence of muscle loss and weakness is reported to be high 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 for 6 weeks on whole body lean mass tissue and measures of muscle strength and functionality in free living community dwelling older adults. A total of 184 participants (92 per group) is required based on a previous study by Norton et al (2015) Participants will be stratified by age, gender and BMI and randomly allocated to consume two sachets of either the BWPH powder daily (12.5g at lunch and dinner (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 mass tissue by Tanita body composition monitor, hand grip strength, a 'timed get up and go' test, chair stand test, blood pressure measurements, a habitual dietary intake questionnaire, quality of life questionnaire, SARC-F (screening tool for sarcopenia) and an MNA questionnaire (mini nutritional assessment). 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). All researchers taking physical measurements will be trained in the correct procedure and will follow a standardised protocol whilst taking all measurements. All physical measurements will be taken with the participant wearing light clothing (without footwear). Measurements will be taken pre- and post-intervention unless otherwise stated. All measurements for each participant will be recorded on a single data collection sheet. Height and weight will be measured to determine BMI (kg/m2). Standing height (m) will be measured (pre-intervention only) to the nearest 0.5cm using a calibrated stadiometer (SECA, Model 220, Germany). Body weight (kg) will be recorded without footwear or heavy clothing and measured to the nearest 0.1kg using portable scales (Seca; Brosch Direct Ltd, Peterborough, UK). A Tanita body composition monitor will use bioelectrical impedance analysis to estimate body composition in all participants, except in those with pacemakers because of the electrical current used. Blood pressure will be measured using an Omron 705CP electronic blood pressure monitor (Medisave, Dorset, UK). A reading will be taken from both arms of each participant, and the arm with the highest reading for each individual will subsequently be used as the reference arm. A mean of two blood pressure readings (taken at least 10 minutes apart while the subject is seated and at-rest) will be taken from the same reference arm at all appointments. A third measurement will be taken if the first two measurements deviate by more than 10%. Hand grip dynamometry will be used to assess grip strength (kg) as a measure of upper body muscle function and will be measured on the non-dominant side three times. In a standing position, with arms at their side (not touching the body and keeping elbows slightly bent), the participant will be asked to hold the device and grip as tightly as possible whilst raising their arm out to the side, taking care to only squeeze once for each measurement. There will be a 10-20 second rest between measurements. A timed up & go test will be conducted to test basic mobility (Podsiadlo & Richardson, 1991). A 3 metre distance will be identified and the participant will be asked to stand up from a chair, walk at a normal pace to the line on the floor which is 3 metres from the chair, turn, walk back to the chair at normal pace and sit down again. The time taken to do this will be recorded. A trained researcher will explain the exact procedure to the participant. A chair stand test will be conducted to assess functional fitness. Participants will be instructed to perform five rises with arms crossed resting hands on their shoulders, moving from a seated position to a stand position. The amount of time spent to perform the test will be reported. The planned statistical analysis will be conducted using the Statistical Package for the Social Sciences (SPSS) for Windows version 24.0 (SPSS Inc, Chicago, IL, USA). Intention to treat analysis will be used. Descriptive statistics will be used to present characteristics pre- and post- intervention. Comparisons will be made (ANCOVA) between the intervention group and control group over time.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sarcopenia
    Keywords
    Sarcopenia, Fish protein, Fish hydrolysates, Protein supplementation, Older adults, Community, Muscle strength

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Double-blind randomised control trial
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Participants are assigned to intervention groups by chance
    Allocation
    Randomized
    Enrollment
    184 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Fish protein supplement
    Arm Type
    Experimental
    Arm Description
    Blue Whiting Protein Hydrolysate
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Isocalorific Maltodextrin Citrus Flavoured Powder
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Blue Whiting Protein Hydrolysate
    Intervention Description
    25g Blue Whiting Protein Hydrolysates mixed with an everyday food / drink product daily for 6 weeks
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    Isocalorific maltodextrin citrus flavoured powder mixed with an everyday food / drink product for 6 weeks
    Primary Outcome Measure Information:
    Title
    Lean mass
    Description
    Assessed via Tanita body composition monitor
    Time Frame
    Change over 6 weeks
    Secondary Outcome Measure Information:
    Title
    Muscle strength
    Description
    Measured via hand grip dynamometry
    Time Frame
    Change over 6 weeks
    Title
    Muscle functionality
    Description
    Measured via hand grip dynamometry
    Time Frame
    Change over 6 weeks
    Title
    Mobility
    Description
    Assessed through timed get up and go test (time to walk 3 metres)
    Time Frame
    Change over 6 weeks
    Title
    Mobility
    Description
    Assessed through chair stand test
    Time Frame
    Change over 6 weeks
    Other Pre-specified Outcome Measures:
    Title
    General clinical chemistry
    Description
    Full lipid profile (Total, HDL & triacylglycerols) measured photometrically on an automatic analyser. LDL will be calculated by the Friedewald formula
    Time Frame
    Change over 6 weeks
    Title
    General clinical chemistry
    Description
    Vitamin B status
    Time Frame
    Change over 6 weeks
    Title
    General clinical chemistry
    Description
    Vitamin D status
    Time Frame
    Change over 6 weeks
    Title
    General clinical chemistry
    Description
    Pro inflammatory markers (Human panel 1) measured on Meso Scale Discovery
    Time Frame
    Change over 6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Individuals residing in a residential care facility Willing to participate in the study Without major cognitive impairment Not regularly taking protein supplements Not at end-of-life stage Exclusion Criteria: At end-of-life stage. Major cognitive impairment Exclusively receiving enteral or parenteral nutrition Food allergy or intolerance that would prevent consumption of the study supplement (e.g. fish) Currently taking any protein supplement
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    • Philip J Allsopp
    Phone
    +442870123125
    Email
    pj.allsopp@ulster.ac.uk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mary M Slevin
    Phone
    +44870123041
    Email
    mm.slevin@ulster.ac.uk

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Company funded research

    Learn more about this trial

    Fish Protein Supplementation and Sarcopenia Outcomes in Carehomes

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