Nutritional Supplementation in Geriatric Hip Fractures
Part of paid clinical trials in New York, New York.
- Sponsor
- NYU Langone Health
- Study ID
- NCT06773000
- Status
- Recruiting
Conditions
- Geriatric Hip Fracture
Eligibility Criteria
- Sex
- ALL
- Age
- 65 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- XR™ Recovery Supplement — DIETARY_SUPPLEMENTParticipants 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 — DIETARY_SUPPLEMENT2 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.
Study Details
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?
Key Dates
- Start date
- Jan 16, 2025
- Status verified
- Mar 2026
- Primary completion
- Jun 30, 2027
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 118 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: XR™ Recovery Supplement2 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 counselingThe control group will receive standard of care nutritional counseling with a registered dietician once during inpatient admission, without the use of the supplement.
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
- Abhishek Ganta, MD(951) 492-8945
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | - |
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