Fish Protein Supplementation and Sarcopenia Outcomes in the Community

NCT05356559 | Unknown

• 1 other identifier: 21/EM/0140
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Keywords

Sarcopenia; Fish protein; Fish hydrolysates; Protein supplementation; Older adults; Community; Muscle strength

Outcome Measures

Primary Outcomes (1)

• Lean weight

  Measured by Bio-Electrical Impedance Analysis

  Change over 8 weeks

Secondary Outcomes (7)

• Muscle strength

  Change over 8 weeks

• Mobility

  Change over 8 weeks

• Exercise tolerance

  Change over 8 weeks

• Blood pressure

  Change over 8 weeks

• Walking speed

  Change over 8 weeks

Other Outcomes (5)

• Lipid profile

  Change over 8 weeks

• Vitamin D status

  Change over 8 weeks

• Inflammation

  Change over 8 weeks

Study Arms (2)

Fish protein

ACTIVE COMPARATOR

Dietary Supplement: Intervention

Control

PLACEBO COMPARATOR

Other: Control

Interventions

Intervention DIETARY_SUPPLEMENT

12.5g (twice daily) Blue Whiting Protein Hydrolysates daily for 8 weeks

Fish protein

Control OTHER

Isocalorific Maltodextrin Citrus Flavoured Powder for 8 weeks

Control

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ulster: lead
• University of Limerick: collaborator
• Bio-Marine Ingredients Ireland: collaborator

Study Sites (1)

Human Intervention Studies Unit, Ulster University / Physical Education and Sport Sciences,

Coleraine / Limerick, Co.Londonderry / Ireland, BT52 1SA / V94 T9PX, United Kingdom

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Methods

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Philip J Allsopp

CONTACT

+44 28 7012 3125; pj.allsopp@ulster.ac.uk

Mary M Slevin

CONTACT

+44 08 7012 3041; mm.slevin@ulster.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel randomised control trial.

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: May 2, 2022
• Study Start: April 25, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)