SarcopeniaSARCO_COMMNCT05356559
Fish Protein Supplementation and Sarcopenia Outcomes in the Community
A study testing Intervention in people with Sarcopenia, run by University of Ulster at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Apr 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Human Intervention Studies Unit, Ulster University / Physical Education and Sport Sciences,
Coleraine / Limerick, Co.Londonderry / Ireland, BT52 1SA / V94 T9PX
Ruth K Price, +442870123878, rk.price@ulster.ac.uk
Julie J Sittlington, +442870124101, jj.sittlington@ulster.ac.uk
About this study
Official title: 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.
Read more
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
- Being tested
- Intervention, Control
- Keywords
- Sarcopenia, Fish protein, Fish hydrolysates, Protein supplementation, Older adults, Community, Muscle strength
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionDietary supplement
12.5g (twice daily) Blue Whiting Protein Hydrolysates daily for 8 weeks
ControlOther
Isocalorific Maltodextrin Citrus Flavoured Powder for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Fish protein | Active comparator | Not described Receives: Dietary Supplement: Intervention |
| Control | Placebo comparator | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lean weight
Measured by Bio-Electrical Impedance Analysis
Measured: Change over 8 weeks
Secondary outcomes (7)
Muscle strength
Measured via hand grip dynamometry
Measured: Change over 8 weeks
Mobility
Assessed through 3 meter Timed up and go Test (time to walk 3 metre)
Measured: Change over 8 weeks
Exercise tolerance
Six minute walk test - distance travelled over 6 minutes
Measured: Change over 8 weeks
Blood pressure
Measured by a brachial blood pressure monitor
Measured: Change over 8 weeks
Walking speed
Assessed by the gait speed test in a 4-meter distance
Measured: Change over 8 weeks
Functional fitness
Assessed by time taken to perform five rises with arms crossed resting hands on their shoulders from seated.
Measured: Change over 8 weeks
Lean weight
Measured by DXA scanner (grams) (Ulster site only)
Measured: Change over 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start25 Apr 2022 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel randomised control trial.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- University of Limerick, Bio-Marine Ingredients Ireland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356559
- Sponsor's protocol ID
- 21/EM/0140
- Acronym
- SARCO_COMM
- Status last verified
- Apr 2022
- First submitted
- 10 Mar 2022
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blue Whiting Protein Hydrolysates and Sarcopenia Outcomes in Free-living, Community Dwelling Older Adults (SARCO_COMM).
- ClinicalTrials.gov ID
- NCT05356559
- Acronym / sponsor ID
- SARCO_COMM / 21/EM/0140
- Conditions
- Sarcopenia
- Keywords
- Sarcopenia, Fish protein, Fish hydrolysates, Protein supplementation, Older adults, Community, Muscle strength
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- University of Limerick, Bio-Marine Ingredients Ireland
- Study start
- 25 Apr 2022 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel randomised control trial.
| Arm | Type | Receives |
|---|---|---|
| Fish protein | Active comparator | Dietary Supplement: Intervention |
| Control | Placebo comparator | Other: Control |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention12.5g (twice daily) Blue Whiting Protein Hydrolysates daily for 8 weeks | Dietary supplement | Fish protein |
| ControlIsocalorific Maltodextrin Citrus Flavoured Powder for 8 weeks | Other | Control |
Primary outcome
Lean weight
Time frame: Change over 8 weeks
Measured by Bio-Electrical Impedance Analysis
7 secondary outcomes
Muscle strength
Time frame: Change over 8 weeks
Mobility
Time frame: Change over 8 weeks
Exercise tolerance
Time frame: Change over 8 weeks
Blood pressure
Time frame: Change over 8 weeks
Walking speed
Time frame: Change over 8 weeks
Functional fitness
Time frame: Change over 8 weeks
Lean weight
Time frame: Change over 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Sarcopenia, run by University of Ulster at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philip J Allsopp (+44 28 7012 3125, pj.allsopp@ulster.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lean weight (time frame: Change over 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.