Nutritional Supplementation in Geriatric Hip Fractures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: XR™ Recovery Supplement, XR Carbohydrate Loading Supplement.
- Who it may be relevant to
- Registry conditions: Geriatric Hip Fracture. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Can Complex Carbohydrates and Essential Amino Acid Supplementation Improve Outcomes Following Geriatric Hip Fractures
Overview
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?
Interventions
- Dietary supplement 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. - Dietary supplement 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 measures
- 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)]
Secondary outcome measures (6)
- 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]
- 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)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT06773000 · 24-00895