Multicenter, prospective, randomized, double-blind, interventional study with a nutritional supplement against placebo in a cohort of patients hospitalized for hip fracture.
Hip fracture is a very prevalent pathology in the elderly population. It is estimated that 35-40% of people over 65 suffer a drop per year, and above 75 years this percentage is even higher, with hip fractures being one of the most serious consequences.With regard to malnutrition, the investigators know that aging carries an increased risk of suffering from decreased appetite and intake and changes in body composition. According to different series, the percentage of malnutrition in patients with hip fracture ranges from 13% to 60%. According to the hospital protocols in Spain in elderly people with spontaneous hip fracture, it is important to perform a nutritional screening during the first 24-48 hours of admission, to evaluate their nutritional status and apply a dietary treatment. The IRENE study aims to determine whether phase angle and reactance, measured by electrical bioimpedance by vector analysis (BIVA) are related to functional recovery in patients with hip fracture.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
82
The product under study has a liquid presentation, in 200 ml bottles, ready to take
The control product will be prepared with equal presentation and taste as similar as possible tan study product
Hospital Clínico de Málaga
Málaga, Andalusia, Spain
Hospital Virgen del Rocío
Seville, Andalusia, Spain
Compare changes in nutritional status between groups based on phase angle
Compare changes in nutritional status between patients taking nutritional supplement under study and control group based on phase angle measurement (morphological criterion)
Time frame: From baseline to month 4
Compare changes in nutritional status between groups based on force measurement
Compare changes in nutritional status between patients taking nutritional supplement under study and control group based on force measurement using hand-grip strength ( functional criteria).
Time frame: From baseline to month 4
To compare functional recovery
Compare functional recovery using the Barthel Scale between patients taking nutritional supplement under study and placebo. It is scored on a scale ranging from 0 to 100, with 90 being the maximum score if the patient is in a wheelchair.
Time frame: From baseline to month 4
To compare the morphological recovery by muscle ultrasound
Compare the morphological recovery valued by muscle ultrasound between patients taking nutritional supplement under study and placebo. Ultrasound performed at baseline and month 4
Time frame: From baseline to month 4
To compare changes in Mini Nutrition Assessment test for aged people
Compare changes in the Mini Nutrition Assessment score between the two study groups. This is a validated test for aged people to assess the nutritional status. Good nutritional state: more than 17points. Bad nutritional state: less than 17 points.
Time frame: From baseline to month 4
To compare the evolution of the Global Subjective Valuation questionnaire
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To compare the evolution of the Global Subjective Valuation between the two study groups. It is a method designed to estimate nutritional status through medical history and physical examination. Each of the sections is valued as mild, moderate or severe, being severe the worst nutritional condition.
Time frame: From baseline to month 4
Compare changes between groups in the Charlson index
Charlson index takes into account the number and severity of accompanying diseases to predict the risk of death. Each pathology that patient has, has a number. The higher the number, the worst prediction.
Time frame: From baseline to month 4
Number of participants that have to be readmitted at the hospital.
Compare the difference in hospital re-admissions between the two study groups.
Time frame: From baseline to month 4
Number of participants that die during the study
Compare the differences in mortality within four months of the start of the study between the two study groups
Time frame: From baseline to month 4
Compare changes in the ratio RCP/Prealbumin index in the blood analysis
Compare changes in the ratio RCP/Prealbumin index between the two study groups.
Time frame: From baseline to month 4