NYU Langone Health
New York, 10016, United States
Location status: Recruiting
Recruiting
NCT Number: NCT06773000
Nutritional Supplementation in 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?
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
65 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Male or female, aged 65 years or older.
- Presenting with a geriatric hip fracture (femoral neck, intertrochanteric, or subtrochanteric) requiring surgical intervention.
- Able to provide informed consent.
- Expected to survive at least 6 months after surgery, with no terminal illness.
Exclusion criteria
- Pre-existing conditions that significantly impair mobility prior to injury.
- Severe renal or liver impairment.
- Active treatment with investigational drugs or participation in another clinical trial within the last 30 days.
- Inability to tolerate oral nutritional supplementation due to gastrointestinal disorders.
- Allergies to any components of the nutritional supplement being tested.
Treatment and study plan
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.
Primary outcomes
-
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)
Outcome measure will be measured using ultrasound imaging.
Secondary outcomes
-
Number of inpatient complications related to the surgical procedure for hip fractures
Time frame: From admission (visit 1) until discharge (~72 hours post-operation)
-
Number of wound complications
Time frame: Visit 5, up to 6 months
Complications include infection and bleeding.
-
Length of hospital stay
Time frame: From admission (visit 1) until discharge (~72 hours post-operation)
-
Rate of readmission
Time frame: Visit 7 (1 year post operation)
-
Mortality Rate
Time frame: Visit 7 (1 year post operation)
-
Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score
Time frame: Baseline, Visit 7 (1 year post operation)
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
NYU Langone Health
Other
Registry information
Official study title
Can Complex Carbohydrates and Essential Amino Acid Supplementation Improve Outcomes Following Geriatric Hip Fractures
Important dates
- Study start
- 2025
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Jan 14, 2025
- Registry last updated
- Mar 3, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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View Trial Details