Nutritional Supplementation for Hip Fractures

Overseen By Abhishek Ganta, MD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Investigational drugs

Disqualifiers: Severe renal, liver impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

118 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a specific nutritional supplement can reduce muscle loss in individuals recovering from hip surgery. It compares two groups: one receiving standard nutritional advice and the other taking the XR Recovery supplement. The focus is on determining if the supplement helps maintain thigh muscle mass using ultrasound. The trial seeks participants who are 65 or older, have experienced a hip fracture requiring surgery, and can tolerate oral supplements. As an unphased trial, this study allows participants to contribute to important research that could enhance recovery outcomes for future patients.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are actively being treated with investigational drugs or participating in another clinical trial, you would not be eligible to join this study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that taking oral carbohydrate supplements before surgery, such as XR Carbohydrate Loading, can aid recovery by reducing stress and stabilizing blood sugar levels. However, limited safety information exists specifically for the XR Carbohydrate Loading Supplement. This supplement aims to assist muscle recovery and reduce swelling after surgery.

While nutritional supplements are generally safe, the limited study of this product means not all safety aspects are known. Prospective trial participants should discuss any concerns with the trial coordinators or their doctors. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard care for hip fractures, which typically involves nutritional counseling and general dietary recommendations, the XR™ Recovery Supplement offers a targeted approach. This treatment is unique because it combines carbohydrate loading before surgery with a specialized recovery supplement taken twice daily for three weeks after surgery. Researchers are excited about this regimen as it aims to enhance energy availability and improve recovery outcomes, potentially leading to faster healing and better overall patient recovery.

What evidence suggests that the XR™ Recovery Supplement could be effective for hip fractures?

This trial will compare the XR™ Recovery Supplement with standard nutritional counseling for hip fracture recovery. Studies have shown that the XR™ Recovery Supplement might help reduce muscle loss after hip surgery. The supplement was designed to address the stress and muscle breakdown common during recovery. Early results suggest that taking these supplements before and after surgery could help preserve muscle. However, its effectiveness specifically for hip fracture cases remains under investigation. Initial signs are promising, but further research is needed to confirm these benefits. ^{1 2 3 5 6}

Who Is on the Research Team?

Abhishek Ganta, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for older adults who have had a hip fracture. Participants should be able to take nutritional supplements and follow the study's procedures. Specific details about who can or cannot join are not provided, but typically there would be criteria based on age, health status, and type of hip fracture.

Inclusion Criteria

I need surgery for a hip fracture.

Able to provide informed consent

I am expected to live more than 6 months after surgery without a terminal illness.

Exclusion Criteria

Allergies to any components of the nutritional supplement being tested

I had mobility issues before my injury.

I have severe kidney or liver problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Supplementation

Participants receive 2 packets of XR Carbohydrate Loading the evening before surgery and one packet on the day of surgery up to 2 hours prior to the scheduled operating time

1 day

Post-operative Supplementation

Participants take the XR™ Recovery Supplement twice daily for three weeks following their surgery

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including muscle loss and wound complications

1 year

What Are the Treatments Tested in This Trial?

Interventions

• XR Carbohydrate Loading Supplement
• XR™ Recovery Supplement

Trial Overview The trial tests if taking XR™ Recovery Supplement or XR Carbohydrate Loading Supplement after surgery helps reduce muscle loss compared to standard advice on nutrition. Patients are randomly assigned to either get the supplement or receive regular dietary counseling.

How Is the Trial Designed?

Group I: XR™ Recovery Supplement Experimental Treatment 2 Interventions

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.

Group II: Standard nutritional counseling Active Control 1 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 Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

In a study of 1123 geriatric patients undergoing hip fracture surgery, the use of oral nutritional supplements (ONS) did not lead to a reduction in perioperative complications or mortality rates at 30 days, 90 days, or 1 year.

However, patients receiving ONS had significantly higher albumin levels before discharge, indicating an improvement in nutritional status, which may warrant further investigation into its long-term effects on recovery and functional outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Oral Nutritional Supplements in Patients Undergoing Surgical Intervention for Hip Fracture. Ashkenazi, I., Rotman, D., Amzalleg, N., et al.[2022]

In a study of 46 older adults recovering from hip fracture surgery, those who consumed a high-protein supplement (Boost HP) showed a significant improvement in serum albumin levels compared to those on a standard supplement (Ensure), indicating better protein status.

While both supplements were well tolerated and had similar consumption rates, the Boost HP group had a shorter rehabilitation stay (23 days vs. 28 days) and consumed more essential nutrients, suggesting potential benefits of high-protein supplementation in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Provision of high-protein supplement for patients recovering from hip fracture. Neumann, M., Friedmann, J., Roy, MA., et al.[2022]

A total of 94 reports of adverse health events related to red yeast rice (RYR) supplements were analyzed, revealing 187 adverse drug reactions (ADRs), with the most common being musculoskeletal disorders (64 cases) and gastrointestinal issues (33 cases).

The study highlights significant safety concerns regarding RYR supplements, particularly due to the potential serious adverse effects from monacolin K, indicating a need for further research to fully understand their safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Red yeast rice (Monascus purpureus) supplements: Case series assessment of spontaneously reported cases to The Netherlands Pharmacovigilance Centre Lareb. Vrolijk, MF., van de Koppel, S., van Hunsel, F.[2021]

Over 70% of Americans use dietary supplements daily, yet these products are not required to be approved by the FDA before being sold, leading to potential safety concerns.

While many supplements are widely consumed, there is limited evidence supporting their health benefits in well-nourished adults, and some can cause significant toxicity or interact negatively with prescription medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Effects of Nutraceuticals and Dietary Supplements. Ronis, MJJ., Pedersen, KB., Watt, J.[2020]

Dietary supplement use is common in the military, particularly among Special Operations Forces, but the lack of strict regulations can lead to harmful side effects, as illustrated by a case of drug-induced liver injury from a testosterone prohormone supplement.

Healthcare providers and military personnel need to be informed about the risks associated with dietary supplements and utilize available resources for safety ratings and reporting adverse reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug-induced liver injury secondary to testosterone prohormone dietary supplement use. Hoedebecke, KL., Rerucha, CM., Maxwell, K., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-fractures-bone-2025-2fc77

Nutritional Supplementation for Hip Fractures Trial Overview The trial tests if taking XR™ Recovery Supplement or XR Carbohydrate Loading Supplement after surgery helps reduce muscle loss compared to ...

2. xrscience.org xrscience.org/blogs/education/if-xr%C2%AE-was-formulated-for-surgical-recovery-why-is-everyone-taking-it

If XR® Was Formulated for Surgical Recovery… Why Is ... XR® was conceived to support the profound catabolic stress of surgical recovery—muscle breakdown, inflammation, and slowed wound healing.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12458828/

Effects of preoperative oral carbohydrate on clinical outcomes ... However, the clinical efficacy of preoperative carbohydrate loading specifically in hip fracture surgery remains subject to heterogeneous ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06773000/nutritional-supplementation-in-geriatric-hip-fractures?id=111&slug=osteoporosis

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 ...

5. clinicaltrials.med.nyu.edu clinicaltrials.med.nyu.edu/clinicaltrial/2791/can-complex-carbohydrates-essential/

Clinical Research Studies - NYU The purpose of this research study is to find out if the XR™ Recovery Supplement can help older patients recover better after hip surgery.

6. xrscience.org xrscience.org/products/xcelerated-recovery%E2%84%A2-perioperative-3-week-recovery-program

XR® Surgical Recovery Program The XR® Carbohydrate Loading Drink supports pre-surgical optimization by: Providing complex carbohydrates to reduce surgical stress; Improving glycemic control ...