Recruiting

Nutritional Supplementation

Sponsor:

NYU Langone Health

Code:

NCT06773000

Conditions

Geriatric Hip Fracture

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

XR™ Recovery Supplement

XR Carbohydrate Loading Supplement

Study Details

Brief summary:

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?

Conditions

Geriatric Hip Fracture

Study ID

NCT06773000

Start date

Jan 16, 2025

Status verified date

Mar, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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 Design

Enrollment

118 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

  • Percentage change in muscle loss, as measured by the cross-sectional area of the rectus femoris muscle [ Time Frame: Baseline, Visit 7 (1 year post operation) ]

Central Contacts and Locations

Central contacts

Abhishek Ganta, MD

(951) 492-8945Abhishek.ganta@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Mar 3, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-03-03.