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

Trial Summary

What is the purpose of this trial?

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?

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.

What data supports the effectiveness of the treatment XR Carbohydrate Loading Supplement, XR™ Recovery Supplement for hip fractures?

Research shows that nutritional supplementation can significantly reduce complications and mortality in patients with hip fractures by ensuring optimal energy and fluid intake, as seen in a study where the intervention group had a much lower complication rate (15%) compared to the control group (70%). ^{1 2 3 4 5}

Is the XR Carbohydrate Loading Supplement safe for human use?

There is limited safety data specifically for the XR Carbohydrate Loading Supplement, but dietary supplements in general can have potential risks, including adverse reactions and interactions with other medications. It's important to consult with a healthcare provider before using any supplement. ^{6 7 8 9 10}

How is the XR Carbohydrate Loading Supplement, XR™ Recovery Supplement treatment different from other treatments for hip fractures?

The XR Carbohydrate Loading Supplement and XR™ Recovery Supplement are unique because they focus on improving nutritional status, which is crucial for recovery after hip fracture surgery. Unlike standard treatments that may not address nutrition, these supplements aim to enhance recovery by increasing albumin levels, a marker of nutritional health, although they do not reduce perioperative complications or mortality. ^{2 3 4 11 12}

Research Team

Abhishek Ganta, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Nutritional supplementation decreases hip fracture-related complications. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Nutritional supplements after hip fracture: poor compliance limits effectiveness. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness of oral nutritional supplementation for older women after a fracture: rationale, design and study of the feasibility of a randomized controlled study. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Oral Nutritional Supplements in Patients Undergoing Surgical Intervention for Hip Fracture. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The effects of nutritional status on outcome after hip fracture. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Red yeast rice (Monascus purpureus) supplements: Case series assessment of spontaneously reported cases to The Netherlands Pharmacovigilance Centre Lareb. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Adverse Effects of Nutraceuticals and Dietary Supplements. [2020]

8. Poland pubmed.ncbi.nlm.nih.gov

Postmarketing nutrivigilance safety profile: a line of dietary food supplements containing red yeast rice for dyslipidemia. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Dietary supplement adverse event reports: review and analysis. [2012]

10. United States pubmed.ncbi.nlm.nih.gov

Drug-induced liver injury secondary to testosterone prohormone dietary supplement use. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Oral nutritional support in hip fracture patients. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Provision of high-protein supplement for patients recovering from hip fracture. [2022]