Fish Protein Supplementation and Sarcopenia Outcomes in Carehomes

NCT05637450 | Unknown

• 1 other identifier: 22/NI/0108
• Study Type: interventional
• Target: 184
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sarcopenia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Lean mass

  Assessed via Tanita body composition monitor

  Change over 6 weeks

Secondary Outcomes (4)

• Muscle strength

  Change over 6 weeks

• Muscle functionality

  Change over 6 weeks

• Mobility

  Change over 6 weeks

• Mobility

  Change over 6 weeks

Other Outcomes (4)

• General clinical chemistry

  Change over 6 weeks

• General clinical chemistry

  Change over 6 weeks

• General clinical chemistry

  Change over 6 weeks

Study Arms (2)

Fish protein supplement

EXPERIMENTAL

Blue Whiting Protein Hydrolysate

Dietary Supplement: Blue Whiting Protein Hydrolysate

Placebo

PLACEBO COMPARATOR

Isocalorific Maltodextrin Citrus Flavoured Powder

Dietary Supplement: Placebo

Interventions

Blue Whiting Protein Hydrolysate DIETARY_SUPPLEMENT

25g Blue Whiting Protein Hydrolysates mixed with an everyday food / drink product daily for 6 weeks

Fish protein supplement

Placebo DIETARY_SUPPLEMENT

Isocalorific maltodextrin citrus flavoured powder mixed with an everyday food / drink product for 6 weeks

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

• Philip J Allsopp

CONTACT

+442870123125; pj.allsopp@ulster.ac.uk

Mary M Slevin

CONTACT

+44870123041; mm.slevin@ulster.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants are assigned to intervention groups by chance
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind randomised control trial

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 5, 2022
• Study Start: July 1, 2023
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: December 5, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share