NCT06773000|Recruiting
Nutritional Supplementation in Geriatric Hip Fractures
Can Complex Carbohydrates and Essential Amino Acid Supplementation Improve Outcomes Following Geriatric Hip Fractures
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Can Complex Carbohydrates and Essential Amino Acid Supplementation Improve Outcomes Following Geriatric Hip Fractures
Sponsor study identifier
interventional
118
1 country
1
Study Start
January 16, 2025
Actual (reported)Primary Completion
June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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?
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 9, 2025
Actual (reported)January 14, 2025
Actual (reported)January 16, 2025
Actual (reported)June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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)
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
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)
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.
The control group will receive standard of care nutritional counseling with a registered dietician once during inpatient admission, without the use of the 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.
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.
NYU Langone Health
New York, New York, 10016, United States
Abhishek Ganta, MD
NYU Langone Health
First Submitted
January 9, 2025
First Posted
January 14, 2025
Study Start
January 16, 2025
Actual (reported)Primary Completion
June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Study Completion
June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
March 3, 2026
Record last verified: 2026-03
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.
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Source: ClinicalTrials.gov.
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