Nutritional Supplementation in Geriatric Hip Fractures

NYU Langone Health

Status: Enrolling

Conditions: Geriatric Hip Fracture

Treatments: Dietary Supplement: XR Carbohydrate Loading Supplement; Dietary Supplement: XR™ Recovery Supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT06773000

24-00895

Details and patient eligibility

About

This study is a randomized controlled trial comparing outcomes between geriatric hip fractures who received a commercially available (XR RecoveryTM, Salt Lake City Utah) peri-operative nutritional supplement for three weeks post-operatively to those who receive standard nutritional counseling. The main question it aims to answer is:

• Does supplementation decrease muscle loss via ultrasound measurements of the cross-sectional area of the rectus femoris of the uninjured leg?

Enrollment: 118 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female, aged 65 years or older.
2. Presenting with a geriatric hip fracture (femoral neck, intertrochanteric, or subtrochanteric) requiring surgical intervention.
3. Able to provide informed consent.
4. Expected to survive at least 6 months after surgery, with no terminal illness.

Exclusion criteria

1. Pre-existing conditions that significantly impair mobility prior to injury.
2. Severe renal or liver impairment.
3. Active treatment with investigational drugs or participation in another clinical trial within the last 30 days.
4. Inability to tolerate oral nutritional supplementation due to gastrointestinal disorders.
5. Allergies to any components of the nutritional supplement being tested.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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118 participants in 2 patient groups

XR™ Recovery Supplement

Experimental group

Description:

2 packets of XR Carbohydrate Loading will be administered the evening before surgery and one packet on the day of surgery up to 2 hours prior to the scheduled operating time. Participants will then take the XR™ Recovery Supplement twice daily for three weeks following their surgery.

Treatment:

Dietary Supplement: XR™ Recovery Supplement

Dietary Supplement: XR Carbohydrate Loading Supplement

Standard nutritional counseling

No Intervention group

Description:

The control group will receive standard of care nutritional counseling with a registered dietician once during inpatient admission, without the use of the supplement.