Nutrition Supplements for Trauma

Overseen By Krista Haines, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Traumatic brain injury, Pregnancy, others

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

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a prospective, randomized, controlled trial designed to evaluate the impact of enhanced protein supplementation compared to a standard of care nutrition delivery in critically ill older adult trauma patients. Subjects will be randomized 1:1 to either enhanced nutrition or control arm. Subjects randomized to the enhanced nutrition arm will receive oral nutrition supplements (ONS) up to 3 times per day while in the hospital and for 4 weeks after discharge. Subjects in the standard of care arm will receive normal nutrition recommendations from their clinical providers. Participants in both groups will undergo non-invasive tests that measure how much energy (calories) they are using, body composition, and muscle mass.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on adding nutrition supplements, so you may not need to stop your medications, but it's best to check with the trial organizers.

What data supports the effectiveness of the treatment Nutrition Supplements - Fresubin KCAL Drinks for trauma patients?

Research shows that early nutritional support, including appropriate caloric and protein intake, can improve outcomes for trauma patients by reducing mortality, complications, and hospital stay. Additionally, formulas with low inflammatory properties have been found to enhance clinical outcomes in critically ill patients. ^{1 2 3 4 5}

Is it safe to use nutrition supplements like Fresubin KCAL Drinks?

While specific safety data for Fresubin KCAL Drinks is not available, dietary supplements in general have been associated with adverse events (unwanted side effects) in some cases. It's important to consult with a healthcare provider before starting any new supplement to ensure it is safe for you. ^{6 7 8 9 10}

How does the treatment Fresubin KCAL Drinks differ from other treatments for trauma?

Fresubin KCAL Drinks are unique because they provide complete nutrition in a lower calorie format, which is beneficial for patients with low energy needs or those who are overweight, ensuring they receive necessary vitamins and minerals without excess calories. This is particularly useful for trauma patients who may have altered metabolism and require careful nutritional management. ^{1 2 11 12 13}

Research Team

Paul Wischmeyer, MD

Principal Investigator

Duke University

Eligibility Criteria

This trial is for older adults who have experienced trauma or critical illness and are in need of nutritional support. Participants must be able to consume oral nutrition supplements and follow the study protocol both during their hospital stay and for four weeks after discharge.

Inclusion Criteria

I am 45 or older and was treated in the ER for a serious injury.

I can eat and drink without assistance.

Patients who have had a standard of care CT scan this admission

Exclusion Criteria

Pregnancy for women of child-bearing potential

I am on a mechanical ventilator.

I have had a traumatic brain injury.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either enhanced protein supplementation or standard nutrition care during hospitalization and for 4 weeks post-discharge

4 weeks

Daily visits during hospitalization, 1 visit post-discharge

Follow-up

Participants are monitored for changes in body composition, muscle strength, and functional outcomes

4 weeks

1 visit (in-person) at one month post-discharge

Treatment Details

Interventions

• Nutrition Supplements - Fresubin KCAL Drinks

Trial Overview The study compares enhanced protein supplementation (Fresubin KCAL Drinks up to three times daily) with standard nutrition care provided by clinical providers. The goal is to see if extra protein helps improve recovery in trauma patients.

Participant Groups

Group I: Enhanced Protein Supplementation Experimental Treatment 1 Intervention

Oral nutrition supplements (ONS) will be given, at maximum, three times per day throughout hospitalization. Upon discharge, participants will be given 4-weeks' worth of oral supplements to take. Adjustments may be made based on indirect calorimetry (IC) measurements.

Group II: Control Pathway Active Control 1 Intervention

Standard of care nutrition delivery throughout hospitalization. Upon discharge participants will be sent home with standard nutrition information without Indirect Calorimetry (IC) guidance.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Findings from Research

73% of Navy and Marine Corps personnel reported using dietary supplements regularly, with multivitamins and protein supplements being the most common, indicating a high prevalence of supplement use in this population.

22% of dietary supplement users experienced adverse events, with combination products showing a particularly high rate of 29%, highlighting potential safety concerns associated with these supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence, Adverse Events, and Factors Associated with Dietary Supplement and Nutritional Supplement Use by US Navy and Marine Corps Personnel. Knapik, JJ., Trone, DW., Austin, KG., et al.[2022]

Fresubin1000 Complete is a new enteral tube feed that provides all necessary nutrients, including fiber, in just 1000 kcal per liter, making it suitable for patients with low energy needs or those who are overweight.

This product addresses the challenge of ensuring complete nutrition while reducing caloric intake, as it is designed to meet all vitamin, mineral, and trace element requirements without exceeding energy needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Solving the problem of weight control for tube-fed patients. Kemp, S.[2017]

References

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

Improvement in Protein Delivery for Critically Ill Patients Requiring High-Dose Propofol Therapy and Enteral Nutrition. [2021]

2. Thailand pubmed.ncbi.nlm.nih.gov

Early nutritional support in severe traumatic patients. [2004]

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

The effect of low dietary inflammatory index score formula on inflammatory, metabolic, and clinical outcomes in critically ill traumatic brain injury patients: A single-blind randomized controlled pilot study. [2023]

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

Update on postinjury nutrition. [2021]

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

How Many Nonprotein Calories Does a Critically Ill Patient Require? A Case for Hypocaloric Nutrition in the Critically Ill Patient. [2017]

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

Caffeinated energy drinks: adverse event reports to the US Food and Drug Administration and the National Poison Data System, 2008 to 2015. [2023]

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

Using the Dietary Supplement Label Database to Identify Potentially Harmful Dietary Supplement Ingredients. [2020]

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

Prevalence, Adverse Events, and Factors Associated with Dietary Supplement and Nutritional Supplement Use by US Navy and Marine Corps Personnel. [2022]

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

Dietary supplement adverse events: report of a one-year poison center surveillance project. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Energy drink exposures reported to Texas poison centers: Analysis of adverse incidents in relation to total sales, 2010-2014. [2018]

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

Solving the problem of weight control for tube-fed patients. [2017]

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

Complete enteral support of thermally injured patients. [2019]

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

New paradigm in nutrition support: using evidence to drive practice. [2012]