Nutritional Support in Femur Fracture Rehabilitation

Barichella Michela

Status: Terminated

Conditions: Femur Fracture

Treatments: Dietary Supplement: Fortifit®

Study type: Interventional

Funder types: Other

Identifiers

NCT04306536

parere 72_2020bis

Details and patient eligibility

About

This randomized, observer-blinded trial tested the hypothesis that nutritional supplementation with muscle-target nutritional supplementation would increase the efficacy of a physical rehabilitation program in old adults with femur fracture treated with surgery.

Full description

Muscle-target nutritional supplementation has been domonstrated to enhance the recovery of muscle mass and increase the efficacy of a rehabilitation program in patients suffering from sarcopenia. Femure fracture is responsible for increased immobilization resulting in loss of muscle mass which may be further emphasized by surgical stress. This randomized, observer-blinded trial tested the hypothesis that nutritional supplementation with muscle-target nutritional supplementation would increase the efficacy of a physical rehabilitation program in old adults with femur fracture treated with surgery.

Enrollment: 20 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 60 years or older
• admission for physical rehabilitation after surgery for femur fracture
• informed consent

Exclusion criteria

• Any malignant disease during the last five years

• Known kidney failure (previous glomerular filtration rate <30 ml/min);

• Known liver failure (Child B or C)

• Psychiatric disease

• Severe cognitive impairment (Mini Mental State Examination <18)

• Endocrine disorders associated with disorders of calcium metabolism (excluding osteoporosis)

• Indications related to the study product:

  1. More than 10 µg (400 IU) of daily Vitamin D intake from medical sources
  2. More than 500 mg of daily calcium intake from medical sources.
  3. Adherence to a high-energy or high-protein diet (up to three months before starting the study)
  4. Hypersensitivity to any component of the investigational nutritional supplement (including cow milk protein allergy to milk and lactose intolerance)

• Indication to or ongoing artificial nutrition support

• Inclusion in other nutrition intervention trials

• Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements

• Refusal

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Fortifit®

Experimental group

Description:

Best local diet + two servings (40 grams each) of powder (Fortifit®; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, 800 IU vitamin D, and a mixture of vitamins, minerals, and fibers.

Treatment:

Dietary Supplement: Fortifit®

Control group

No Intervention group

Description:

Best local diet