Does a moderate dose fish oil intervention improve outcomes in older adults recovering from hip fracture?

Phase 3

Not yet recruiting

Conditions: Elderly hip fracture patients with malnutrition
Injuries and Accidents - Fractures
Diet and Nutrition - Other diet and nutrition disorders

Registration Number: ACTRN12609000241235

Lead Sponsor: Dr Michelle Miller

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not yet recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

Aged >65 years
- PFF confirmed by radiology report
- Undergone surgery for fixation of hip fracture
- Reside within existing local service boundaries
- Community dwelling
- Preliminary evidence of cachexia (CRP =6mg/L)
- At risk of significant weight loss (SNAQ score =14/20)

Exclusion Criteria

- Severe cognitive impairment (MMSE <18/30)

- PFF not fall-related, is pathological or is peri-prosthetic

- Initiation of anti-inflammatory drugs or corticosteroids within the previous two weeks

- Ingestion of =2g total omega-3 daily as per fish FFQ

- Seafood allergy

- Life expectancy <12 weeks

- Inability to communicate effectively due to blindness, deafness or lack of a translator

- Inability to provide informed consent

- Diagnosed with one of the following haemorrhagic stroke risk factors (Unstable hypertension, Atrial fibrillation, Inherited disorders such as polycystic kidney disease, Ehlers-Danlos syndrome type IV, neurofibromatosis type I, Marfan syndrome, moyamoya disease)

- Diagnosed with a bleeding disorders such as the following (von Willebrand disease or Haemophilia

- Receiving treatment doses of any antithrombotic agent

- Those on dual anti-platelet function drugs or any anti-platelet drugs with exception to low dose aspirin.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health-related quality of life as assessed by the 'Assessment of Quality of Life' (AQoL) tool[At 6 and 12 weeks]

Secondary Outcome Measures

Name	Time	Method
Body composition, assessed by dual-energy x-ray absorptiometry and bioelectrical impedance analysis[At 6 and 12 weeks];Physical function, assessed by timed chair stand test and assessment of physical autonomy by the 'Activities of Daily Living' tool[At 6 and 12 weeks];Levels of inflammatory markers including: C-reactive protein (CRP), Interleukin-1 (IL-1), Interleukin-6 (IL6) and tumour necrosis factor alpha (TNF-alpha)<br>Adherence to the fish oil intervention will be assessed by analysis of essential fatty acids (EPA ad DHA) from the erythrocyte phospholipid membrane[At 6 and 12 weeks];Nutritional status, assessed by the Mini Nutritional Assessment and percent weight change[At 6 and 12 weeks];Resting energy expenditure (REE), assessed by a hand held portable indirect calorimeter.[At 6 and 12 weeks]