Nutritional Support in Femur Fracture Rehabilitation

NCT ID: NCT04306536

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-19
• Study Completion Date: 2020-12-20

Brief Summary

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.

Detailed 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.

Conditions

Femur Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Fortifit®

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.

Group Type: EXPERIMENTAL

Fortifit®

Intervention Type: DIETARY_SUPPLEMENT

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.

Control group

Best local diet

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Fortifit®

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Barichella Michela

OTHER

Sponsor Role: lead

Responsible Party

Barichella Michela

Study coordinator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lorenzo Panella, MD

Role: PRINCIPAL_INVESTIGATOR

ASST Gaetano Pini-CTO

Locations

Asst Gaetano Pini

Milan, , Italy

Countries

Italy

Other Identifiers

parere 72_2020bis

Identifier Type: -

Identifier Source: org_study_id