Nutritional Supplementation in Geriatric Hip Fractures

Can Complex Carbohydrates and Essential Amino Acid Supplementation Improve Outcomes Following Geriatric Hip Fractures

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?

Study Overview

• Status: Recruiting
• Conditions: Geriatric Hip Fracture
• Intervention / Treatment: Dietary supplement: XR™ Recovery Supplement; Dietary supplement: XR Carbohydrate Loading Supplement

• Study Type: Interventional
• Enrollment (Estimated): 118
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abhishek Ganta, MD; Phone Number: (951) 492-8945; Email: Abhishek.ganta@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: XR™ Recovery Supplement; 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.	Dietary supplement: XR™ Recovery Supplement; Participants will receive a total daily dosage of 59.2 grams of XR™ Recovery Supplement orally, divided into two doses of 29.6 grams each (or two pouches). The dosing regimen will begin upon hospital admission and continue for three weeks post-operatively.; Dietary supplement: XR Carbohydrate Loading Supplement; 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. The powder will be mixed with 14 oz of room temperature water only until dissolved then may be served over ice for desired temperature of consumption by the participant.
No Intervention: Standard nutritional counseling; The control group will receive standard of care nutritional counseling with a registered dietician once during inpatient admission, without the use of the supplement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change in muscle loss, as measured by the cross-sectional area of the rectus femoris muscle	Outcome measure will be measured using ultrasound imaging.	Baseline, Visit 7 (1 year post operation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of inpatient complications related to the surgical procedure for hip fractures		From admission (visit 1) until discharge (~72 hours post-operation)
Number of wound complications	Complications include infection and bleeding.	Visit 5, up to 6 months
Length of hospital stay		From admission (visit 1) until discharge (~72 hours post-operation)
Rate of readmission		Visit 7 (1 year post operation)
Mortality Rate		Visit 7 (1 year post operation)
Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score	A PROMIS PF score is a measurement of physical function that ranges from 0 to 100. The average score is 50, with a standard deviation of 10. A score of 40 is considered below average, indicating decreased physical function, while a score of 60 is considered above average, which indicates increased physical function.	Baseline, Visit 7 (1 year post operation)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Abhishek Ganta, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): January 14, 2025

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: 24-00895

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: REDCap data will be reshared with study sponsor in the form of de-identified aggregate data. Data collected for this study will be analyzed and stored at NYU Langone. After the study is completed, any identifiable information collected during the study will not be used or distributed for future research studies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No