A 16-week Randomized Controlled Trial of a Fish Oil and Whey Protein-Derived Supplement to Improve Physical Performance in Older Adults Losing Autonomy – A Pilot Study

Loss of autonomy is often the trigger for institutionalization of older adults. A nutritional intervention within a rehabilitation program may attenuate loss of muscle mass and function to enable continued autonomy in this understudied group of seniors. Objectives: 1) To assess the feasibility of a combined nutrient supplementation intervention with regards to recruitment, compliance, and completion of assessments in older adults losing autonomy; 2) to characterize this specific population. Seniors taking part in a rehabilitation program were randomized to an intervention with a supplement (EXP: 2 g fish oil (EPA+ DHA) with 1500 IU vitamin D3 1x/d+ 20–30 g whey protein powder with 3 g leucine 2x/d) or placebo (CTR; corn oil and maltodextrin powder) for 16 weeks. Lean soft tissue mass (LM) and physical function were assessed. LM (DXA) was measured at weeks 0 and 16, handgrip and knee extension strength (dynamometry), physical performance tests and plasma phospholipid n-3 fatty acids (GCMS) were evaluated at weeks 0, 8 and 16. Over 2 y, 244 patients were screened, 46 were eligible (18.9%; 95% CI: 15.0, 22.8), 20 were randomized, 10 completed the study (n = 4 in EXP; n = 6 in CTR). Median age was 87 y (77–94 y; 75% women), 35% had low LM, 35% were frail, 85% were using a walking aid daily and physical performance was low, at baseline. Overall self-reported compliance to powder was 96% (95% CI: 83, 108) and to oil, 85% (95% CI: 63, 107). The EXP median protein intake alone surpassed the target 1.2–1.5 g/kg/d for older adults, without altering usual diet. Proportions of EPA and DHA increased significantly 3- and 1.5-fold respectively at week 8 in EXP, with no change in CTR. Participants were able to complete most assessments with sustained guidance. Because of low eligibility limiting the pool of potential patients, the pilot study was interrupted as deemed non-feasible; however, compliance to supplements and the rigorous study assessments was high. Solutions to address recruitment, such as more liberal eligibility criteria, need to be considered in the design of a large-scale RCT before it can be carried out in this challenging population. Helen McCall Hutchison Award and Réseau québécois de la recherche sur le vieillissement of FRQS.