Protein for Bone and mUScle health in hip fracture patients

Rationale: A hip fracture jeopardizes the health status and quality of life of older adults. Only half of the patients regain their pre-fracture functional level and 24% dies within the following year. The risk of reoccurring fractures and increased mortality persists for at least 10 years following the initial fracture. Targeting modifiable risk factors, such as osteoporosis and sarcopenia, are therefore a major area of interest. A high protein intake may be beneficial for older hip fracture patients, it may improve clinical outcomes, slow down postoperative bone and muscle loss. The current study will investigate a unique study population as not much attention is given to the rehabilitation as setting.
Objective: This intervention study investigates the effect of a protein-enriched diet for 6 months on bone health, muscle mass and physical performance in older adults recovering from an acute hip fracture.
Study design: This study will be a 6-month randomized, single-blind, controlled, parallel-group trial.
Study population: Adults aged 65 years and older recovering from an acute hip fracture.
Intervention: There will be two groups, an intervention group receiving a tailor-made protein-enriched diet and a control group receiving usual care.
Main study parameters/endpoints: The primary study parameters are markers of bone turnover (serum C-terminal telopeptide of type I collagen and procollagen type 1 N propeptide), bone mineral density, insulin-like growth factor 1 levels, muscle mass, and physical performance. Secondary parameters include rehabilitation time, sarcopenia prevalence, daily life functioning, and quality of life.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Following a protein-enriched diet for 6 months requires an adaption in the subjects’ dietary habits, but these changes will be tailor-made by consultation with a dietician in order to make the subjects feel comfortable with the diet. Most measurements are part of usual care and are therefore considered to impose no extra burden on subjects. A protein intake of 1.5 g/kg bw/d is safe and probably needed for both bone and muscle health in our study population, as recommended by several expert groups. People with disorders/diseases where a high protein intake can be harmful will be excluded from the study. Concerning the benefits, this study will lead to knowledge about the impact of protein on bone and muscle health outcomes in older adults. It is hypothesized that a higher protein intake has a beneficial effect on bone and muscle health outcomes and subsequently leads to a shorter rehabilitation time.

It is hypothesized that a higher protein intake has a beneficial effect on bone and muscle health outcomes and subsequently leads to a shorter rehabilitation time.

Baseline, discharge from rehabilitation center, 3 and 6 months

There will be two groups, an intervention group receiving a tailor-made protein-enriched diet and a control group receiving usual care.