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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a special protein drink, Nutrition Supplements - Fresubin KCAL Drinks, can aid older adults in recovering after a traumatic injury. Participants will either receive the protein drinks or follow regular dietary advice. The study aims to determine if the extra protein improves energy use, body composition, and muscle mass. It suits trauma patients over 45 who can eat normally and had a CT scan during their hospital stay. As an unphased trial, this study offers participants a unique opportunity to contribute to understanding the potential benefits of protein supplements in recovery.

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.

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

Research shows that nutritional supplements like Fresubin KCAL Drinks are generally safe for most people. Although specific safety data for Fresubin KCAL Drinks is unavailable, other studies suggest that nutrition delivered directly to the stomach is usually well-tolerated. Hospitals often use these supplements to provide patients with necessary energy and protein, especially when they are very sick.

Some studies have found that these supplements can reduce issues like diarrhea without introducing other risks. In general, supplements support health by providing essential nutrients when a regular diet falls short. While specific data on Fresubin KCAL Drinks is limited, similar products have been safely used to enhance nutrition in hospital patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of Fresubin KCAL Drinks for trauma nutrition because they offer enhanced protein supplementation tailored to individual needs. Unlike the standard nutrition care, which provides general guidance without precise caloric measurements, this approach uses indirect calorimetry to adjust protein intake, potentially optimizing recovery. This personalized method could lead to better outcomes for trauma patients by ensuring they receive the exact nutrition their bodies need to heal efficiently.

What evidence suggests that nutrition supplements could be effective for trauma patients?

Research has shown that early nutritional support, including adequate calories and protein, can reduce the risk of death in trauma patients. In this trial, participants in the Enhanced Protein Supplementation arm will receive high-protein, energy-rich drinks, such as Fresubin KCAL, which have increased body cell mass in previous studies. These drinks can enhance the body's strength and recovery. Critically ill patients often lack sufficient protein and calories, so these drinks help meet their nutritional needs. Overall, incorporating these drinks can significantly aid recovery for older trauma patients. ^{1 2 3 6 7}

Who Is on the Research Team?

Paul Wischmeyer, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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.

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

I can eat and drink without assistance.

Exclusion Criteria

Pregnancy for women of child-bearing potential

Subjects for whom the Investigator would recommend a different supplement based on their medical condition

Prisoner

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. mdpi.com mdpi.com/2072-6643/16/18/3136

Effectiveness of High-Protein Energy-Dense Oral ... Patients who consumed two bottles experienced a statistically significant increase in estimated body cell mass compared to those who consumed ...

2. withpower.com withpower.com/trial/phase-wounds-and-injuries-8-2024-89c98

Nutrition Supplements for Trauma · Info for Participants Research shows that early nutritional support, including appropriate caloric and protein intake, can improve outcomes for trauma patients by reducing mortality, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12206743/

Enteral nutrition delivery in patients admitted to a critical ... Critically ill patients are reported to receive as little as 50% of energy and 45% of protein requirements during enteral nutrition support.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02632630

Nutrition Supplementation in Hospitalized Patients This is a randomized controlled pilot trial to rapidly identify at-risk hospitalized medical patients, and then provide nutritional supplementation in hospital ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1279770723017396

The influence of nutritional supplement drinks on providing ... This study aims to test the hypothesis that providing ONS drinks reduces protein and energy intake from food in elderly people with cognitive impairment

6. aspenjournals.onlinelibrary.wiley.com aspenjournals.onlinelibrary.wiley.com/doi/10.1002/jpen.2210

Safety of Using Enteral Nutrition Formulations Containing ... EN formulas with fiber may help reduce incidence and severity of diarrhea and GI complications overall in critically ill patients, without increased risk of ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0261561420305434

Impact of specialized oral nutritional supplement on clinical ... The primary composite outcome was 'survival without hospital (re)admission and with at least 5% weight gain to day 180'. Dietary intakes, nutritional and ...