Fish Protein Supplementation and Sarcopenia Outcomes in the Community (SARCO_COMM)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sarcopenia
• Intervention / Treatment: Dietary supplement: Intervention; Other: Control

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philip J Allsopp; Phone Number: +44 28 7012 3125; Email: pj.allsopp@ulster.ac.uk
• Study Contact Backup: Name: Mary M Slevin; Phone Number: +44 08 7012 3041; Email: mm.slevin@ulster.ac.uk

Study Locations

• United Kingdom
  • Co.Londonderry / Ireland
    • Coleraine / Limerick, Co.Londonderry / Ireland, United Kingdom, BT52 1SA / V94 T9PX
      • Human Intervention Studies Unit, Ulster University / Physical Education and Sport Sciences,
      • Principal Investigator: Richard FitzGerald
      • Contact: Ruth K Price; Phone Number: +442870123878; Email: rk.price@ulster.ac.uk
      • Contact: Julie J Sittlington; Phone Number: +442870124101; Email: jj.sittlington@ulster.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control	Other: Control; Isocalorific Maltodextrin Citrus Flavoured Powder for 8 weeks
Active Comparator: Fish protein	Dietary supplement: Intervention; 12.5g (twice daily) Blue Whiting Protein Hydrolysates daily for 8 weeks

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipid profile	Measured by Clinical Chemistry analyzer	Change over 8 weeks
Vitamin D status	Measured by LC-MS	Change over 8 weeks
Inflammation	Cytokine profile measured by ELISA	Change over 8 weeks
Kidney function	Measured by Clinical Chemistry analyzer	Change over 8 weeks
Liver function	Measured by Clinical Chemistry analyzer	Change over 8 weeks

Collaborators and Investigators

• Sponsor: University of Ulster
• Collaborators: University of Limerick; Bio-Marine Ingredients Ireland

Study record dates

Study Major Dates

• Study Start (Anticipated): April 25, 2022
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: March 10, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Actual): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Sarcopenia; Older adults; Muscle strength; Protein supplementation; Community; Fish protein; Fish hydrolysates
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: 21/EM/0140

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No