Geriatric Hip FractureNCT06773000
Nutritional Supplementation in Geriatric Hip Fractures
A study testing XR™ Recovery Supplement and XR Carbohydrate Loading Supplement in people with Geriatric Hip Fracture, run by NYU Langone Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Geriatric Hip Fracture
- What is being tested?
- XR™ Recovery Supplement and XR Carbohydrate Loading Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: Can Complex Carbohydrates and Essential Amino Acid Supplementation Improve Outcomes Following 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?
- Conditions
- Geriatric Hip Fracture
- Being tested
- XR™ Recovery Supplement, XR Carbohydrate Loading Supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XR™ Recovery SupplementDietary 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 SupplementDietary 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 group | Role | What they receive |
|---|---|---|
| XR™ Recovery Supplement | Experimental | 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. Receives: Dietary Supplement: XR™ Recovery Supplement; Dietary Supplement: XR Carbohydrate Loading Supplement |
| Standard nutritional counseling | No intervention | The control group will receive standard of care nutritional counseling with a registered dietician once during inpatient admission, without the use of the supplement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Visit 7 (1 year post operation)
Secondary outcomes (6)
Number of inpatient complications related to the surgical procedure for hip fractures
Measured: From admission (visit 1) until discharge (~72 hours post-operation)
Number of wound complications
Complications include infection and bleeding.
Measured: Visit 5, up to 6 months
Length of hospital stay
Measured: From admission (visit 1) until discharge (~72 hours post-operation)
Rate of readmission
Measured: Visit 7 (1 year post operation)
Mortality Rate
Measured: Visit 7 (1 year post operation)
Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score
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.
Measured: Baseline, Visit 7 (1 year post operation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start16 Jan 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric Hip FractureStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abhishek Ganta, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773000
- Sponsor's protocol ID
- 24-00895
- Status last verified
- Mar 2026
- First submitted
- 9 Jan 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Complex Carbohydrates and Essential Amino Acid Supplementation Improve Outcomes Following Geriatric Hip Fractures
- ClinicalTrials.gov ID
- NCT06773000
- Acronym / sponsor ID
- 24-00895
- Conditions
- Geriatric Hip Fracture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XR™ Recovery Supplement | Experimental | Dietary Supplement: XR™ Recovery Supplement, Dietary Supplement: XR Carbohydrate Loading 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. |
| Standard nutritional counseling | No intervention | –The control group will receive standard of care nutritional counseling with a registered dietician once during inpatient admission, without the use of the supplement. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XR™ Recovery 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. | Dietary supplement | XR™ Recovery Supplement |
| XR Carbohydrate Loading 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. | Dietary supplement | XR™ Recovery Supplement |
Primary outcome
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.
6 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
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Geriatric Hip Fracture
Not yet recruiting
A Decision Support Tool for Common Surgical Fixations of Hip Fractures
Hip Fracture Surgeries, High Risk Population of Hip Fractures
Not yet recruitingObservational study
Mortality and Predictors of In-hospital Mortality Among Geriatric Patients With Hip Fracture
Hip Fractures, In-hospital Mortality
RecruitingObservational study
Dexmedetomidine for Prevention of Delirium After Hip Fracture Surgery
Delirium - Postoperative, Delirium Prevention
Not yet recruiting
AI-Supported Physiotherapy After Hip Fracture in Frail Older Adults
Hip Fractures, Frailty
Not yet recruitingObservational study
Effects of PNB Timing on Postoperative Delirium for Hip Fracture
Delirium - Postoperative
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Abhishek Ganta, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XR™ Recovery Supplement and XR Carbohydrate Loading Supplement in people with Geriatric Hip Fracture, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abhishek Ganta, MD ((951) 492-8945, Abhishek.ganta@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.