Fish Protein Supplementation and Sarcopenia Outcomes in the Community (SARCO_COMM)
Primary Purpose
Sarcopenia
Status
Not yet recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Intervention
Control
Sponsored by
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
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
Sites / Locations
- Human Intervention Studies Unit, Ulster University / Physical Education and Sport Sciences,
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Fish protein
Control
Arm Description
Outcomes
Primary Outcome Measures
Lean weight
Measured by Bio-Electrical Impedance Analysis
Secondary Outcome Measures
Muscle strength
Measured via hand grip dynamometry
Mobility
Assessed through 3 meter Timed up and go Test (time to walk 3 metre)
Exercise tolerance
Six minute walk test - distance travelled over 6 minutes
Blood pressure
Measured by a brachial blood pressure monitor
Walking speed
Assessed by the gait speed test in a 4-meter distance
Functional fitness
Assessed by time taken to perform five rises with arms crossed resting hands on their shoulders from seated.
Lean weight
Measured by DXA scanner (grams) (Ulster site only)
Full Information
NCT ID
NCT05356559
First Posted
March 10, 2022
Last Updated
April 27, 2022
Sponsor
University of Ulster
Collaborators
University of Limerick, Bio-Marine Ingredients Ireland
1. Study Identification
Unique Protocol Identification Number
NCT05356559
Brief Title
Fish Protein Supplementation and Sarcopenia Outcomes in the Community
Acronym
SARCO_COMM
Official Title
Blue Whiting Protein Hydrolysates and Sarcopenia Outcomes in Free-living, Community Dwelling Older Adults (SARCO_COMM).
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 25, 2022 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 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
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.
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
Parallel randomised control trial.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double-blinded
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fish protein
Arm Type
Active Comparator
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Intervention
Intervention Description
12.5g (twice daily) Blue Whiting Protein Hydrolysates daily for 8 weeks
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Isocalorific Maltodextrin Citrus Flavoured Powder for 8 weeks
Primary Outcome Measure Information:
Title
Lean weight
Description
Measured by Bio-Electrical Impedance Analysis
Time Frame
Change over 8 weeks
Secondary Outcome Measure Information:
Title
Muscle strength
Description
Measured via hand grip dynamometry
Time Frame
Change over 8 weeks
Title
Mobility
Description
Assessed through 3 meter Timed up and go Test (time to walk 3 metre)
Time Frame
Change over 8 weeks
Title
Exercise tolerance
Description
Six minute walk test - distance travelled over 6 minutes
Time Frame
Change over 8 weeks
Title
Blood pressure
Description
Measured by a brachial blood pressure monitor
Time Frame
Change over 8 weeks
Title
Walking speed
Description
Assessed by the gait speed test in a 4-meter distance
Time Frame
Change over 8 weeks
Title
Functional fitness
Description
Assessed by time taken to perform five rises with arms crossed resting hands on their shoulders from seated.
Time Frame
Change over 8 weeks
Title
Lean weight
Description
Measured by DXA scanner (grams) (Ulster site only)
Time Frame
Change over 8 weeks
Other Pre-specified Outcome Measures:
Title
Lipid profile
Description
Measured by Clinical Chemistry analyzer
Time Frame
Change over 8 weeks
Title
Vitamin D status
Description
Measured by LC-MS
Time Frame
Change over 8 weeks
Title
Inflammation
Description
Cytokine profile measured by ELISA
Time Frame
Change over 8 weeks
Title
Kidney function
Description
Measured by Clinical Chemistry analyzer
Time Frame
Change over 8 weeks
Title
Liver function
Description
Measured by Clinical Chemistry analyzer
Time Frame
Change over 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philip J Allsopp
Phone
+44 28 7012 3125
Email
pj.allsopp@ulster.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Mary M Slevin
Phone
+44 08 7012 3041
Email
mm.slevin@ulster.ac.uk
Facility Information:
Facility Name
Human Intervention Studies Unit, Ulster University / Physical Education and Sport Sciences,
City
Coleraine / Limerick
State/Province
Co.Londonderry / Ireland
ZIP/Postal Code
BT52 1SA / V94 T9PX
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruth K Price
Phone
+442870123878
Email
rk.price@ulster.ac.uk
First Name & Middle Initial & Last Name & Degree
Julie J Sittlington
Phone
+442870124101
Email
jj.sittlington@ulster.ac.uk
First Name & Middle Initial & Last Name & Degree
Richard Fitzgerald
12. IPD Sharing Statement
Plan to Share IPD
No
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Fish Protein Supplementation and Sarcopenia Outcomes in the Community
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