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_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 — DIETARY_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.

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 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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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