Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Limerick | OTHER |
| Bio-Marine Ingredients Ireland | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fish protein | Active Comparator |
| |
| Control | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Dietary Supplement | 12.5g (twice daily) Blue Whiting Protein Hydrolysates daily for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lean weight | Measured by Bio-Electrical Impedance Analysis | Change over 8 weeks |
| 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) |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Intervention Studies Unit, Ulster University / Physical Education and Sport Sciences, | Coleraine / Limerick | Co.Londonderry / Ireland | BT52 1SA / V94 T9PX | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
Not provided
Not provided
Parallel randomised control trial.
Not provided
Not provided
Double-blinded
| Control | Other | Isocalorific Maltodextrin Citrus Flavoured Powder for 8 weeks |
|
| 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 |
| 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 |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |