Fish Protein Supplementation and Sarcopenia Outcomes in the Community

Sarcopenia Clinical Trial

— SARCO_COMM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05356559
• Other study ID #: 21/EM/0140
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 25, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: April 2022
• Source: University of Ulster
• Contact: Philip J Allsopp
• Phone: +44 28 7012 3125
• Email: pj.allsopp[@]ulster.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Dietary Supplement:
• Intervention
12.5g (twice daily) Blue Whiting Protein Hydrolysates daily for 8 weeks

Other:
• Control
Isocalorific Maltodextrin Citrus Flavoured Powder for 8 weeks

Locations

Country	Name	City	State
United Kingdom	Human Intervention Studies Unit, Ulster University / Physical Education and Sport Sciences,	Coleraine / Limerick	Co.Londonderry / Ireland

Sponsors (3)

Lead Sponsor	Collaborator
University of Ulster	Bio-Marine Ingredients Ireland, University of Limerick

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lipid profile	Measured by Clinical Chemistry analyzer	Change over 8 weeks
Other	Vitamin D status	Measured by LC-MS	Change over 8 weeks
Other	Inflammation	Cytokine profile measured by ELISA	Change over 8 weeks
Other	Kidney function	Measured by Clinical Chemistry analyzer	Change over 8 weeks
Other	Liver function	Measured by Clinical Chemistry analyzer	Change over 8 weeks
Primary	Lean weight	Measured by Bio-Electrical Impedance Analysis	Change over 8 weeks
Secondary	Muscle strength	Measured via hand grip dynamometry	Change over 8 weeks
Secondary	Mobility	Assessed through 3 meter Timed up and go Test (time to walk 3 metre)	Change over 8 weeks
Secondary	Exercise tolerance	Six minute walk test - distance travelled over 6 minutes	Change over 8 weeks
Secondary	Blood pressure	Measured by a brachial blood pressure monitor	Change over 8 weeks
Secondary	Walking speed	Assessed by the gait speed test in a 4-meter distance	Change over 8 weeks
Secondary	Functional fitness	Assessed by time taken to perform five rises with arms crossed resting hands on their shoulders from seated.	Change over 8 weeks
Secondary	Lean weight	Measured by DXA scanner (grams) (Ulster site only)	Change over 8 weeks