72 Participants Needed

High Protein Diet + Exercise for Muscle Loss

(PROXIMUS Trial)

Recruiting at 1 trial location
NM
LB
Overseen ByLori Bechard, RD, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Boston Children's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

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's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment High Protein Diet + Exercise for Muscle Loss?

Research shows that high protein diets and exercise can help maintain muscle mass in older adults and those experiencing muscle loss due to conditions like sarcopenia (age-related muscle loss) and cachexia (muscle wasting). Protein supplements, especially when combined with resistance exercise, have been found to improve muscle mass and strength.12345

Is a high protein diet with exercise safe for humans?

Research shows that protein supplements, including whey protein, are generally safe for humans when combined with exercise, even in older adults. These studies have not reported significant safety concerns, suggesting that this combination is well-tolerated.23567

How does the High Protein Diet + Exercise treatment differ from other treatments for muscle loss?

This treatment is unique because it combines a high protein diet with individualized exercise prescriptions, which may enhance muscle mass and function more effectively than protein or exercise alone. The focus on personalized exercise plans and specific protein intake timing and dosage sets it apart from standard approaches.89101112

What is the purpose of this trial?

The investigators have designed a 2-center, pilot feasibility, randomized controlled trial (PROXIMUS) to determine the feasibility and safety of a larger multi center, randomized open-label trial comparing high protein combined with individualized exercise vs. standard management during the acute phase of critical illness in children. The investigators aim to determine the impact of the intervention on preservation of muscle mass; and functional status at 1 month and 6 months after randomization.

Research Team

NM

Nilesh Mehta, MD

Principal Investigator

Faculty, Boston Children's Hospital

SR

Sapna R Kudchadkar, MD

Principal Investigator

Faculty, Johns Hopkins

Eligibility Criteria

This trial is for children aged 1 to under 18 years who are on mechanical ventilation within the first 48 hours of PICU admission and expected to stay on it. They must be able to consent within this period. It's not for those with liver failure, certain medical conditions requiring bedrest, high-risk burns, severe kidney issues without therapy, or incompatible diets.

Inclusion Criteria

I am between 1 and 17 years old, corrected for prematurity.
I needed a breathing tube within the first 48 hours of ICU admission and will need it for at least 2 more days.
Able to consent to participate within 48 hours of initiation of mechanical ventilation initiation.

Exclusion Criteria

My kidney function is severely reduced and I am not on dialysis.
I have a genetic disorder that affects my metabolism.
I have severe burns covering a large part of my body.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive high protein combined with individualized exercise or standard management during the acute phase of critical illness

10 days
Daily monitoring during PICU stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments at 1 and 6 months

6 months
Assessments at 1 month and 6 months

Treatment Details

Interventions

  • Protein dosage and rehabilitation team delivered exercise prescription
Trial Overview The PROXIMUS study tests if giving high protein with tailored exercise during critical illness helps maintain muscle mass and improve mobility in kids after treatment. Participants will either receive this new approach or standard care, decided randomly at two centers.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: High protein plus exerciseExperimental Treatment1 Intervention
High protein nutrition: To achieve the prescribed age-appropriate high protein target, dietitians will use EN preferentially, or if EN is contraindicated, PN may be used. High-protein EN formulas and/or protein supplements (powder or liquid) will be added to formula/breast milk feedings or administered separately in divided bolus doses. Dietitians routinely employ and customize these solutions in their scope of practice. When EN is insufficient to meet protein targets, PN may be prescribed to make up the deficit on or after the end of PICU day 3. Energy and protein delivery adequacy (% of prescribed goal) will be monitored daily by the study team. Patients in this arm will also be prescribed the age-appropriate highest-level of mobility by the rehabilitation team with a goal of 30 minutes duration, twice daily.
Group II: Standard protein and exerciseActive Control1 Intervention
All enrolled patients randomized to this arm will receive a baseline nutrition and nurse-driven mobility pathway and other evidence-based bundled strategies as standard of care.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials
801
Recruited
5,584,000+

Johns Hopkins University

Collaborator

Trials
2,366
Recruited
15,160,000+

Findings from Research

Dietary protein supplementation of more than 1.5 g/kg per day may help maintain or improve muscle mass in patients with cachexia, especially when combined with exercise training.
However, there is still a lack of clinical studies directly linking protein intake to muscle weight gain and function, highlighting the need for more research in this area.
Muscle atrophy in cachexia: can dietary protein tip the balance?Op den Kamp, CM., Langen, RC., Haegens, A., et al.[2011]
Whey protein supplementation during resistance exercise training (RET) in older adults with sarcopenia showed a small but significant increase in skeletal muscle mass and handgrip strength compared to RET without whey protein or with a placebo, based on a review of seven trials involving 591 participants.
Despite these positive findings, the overall effect sizes were small and did not exceed the minimally important clinical difference, indicating that while whey protein may help, the clinical significance of the improvements is limited and further research is needed.
Effectiveness of Whey Protein Supplementation during Resistance Exercise Training on Skeletal Muscle Mass and Strength in Older People with Sarcopenia: A Systematic Review and Meta-Analysis.Cuyul-Vásquez, I., Pezo-Navarrete, J., Vargas-Arriagada, C., et al.[2023]
Multi-ingredient protein (MIP) supplements, when combined with resistance training, significantly increased fat-free mass (0.80 kg) and strength (4.22 kg for lower body and 2.56 kg for upper body) compared to non-MIP supplements across 35 trials with 1387 participants.
The benefits of MIP supplements were particularly pronounced in untrained individuals and older adults, showing greater gains in muscle mass and strength compared to those who were already trained or younger, although MIP was not superior to protein-only supplements.
Do multi-ingredient protein supplements augment resistance training-induced gains in skeletal muscle mass and strength? A systematic review and meta-analysis of 35 trials.O'Bryan, KR., Doering, TM., Morton, RW., et al.[2022]

References

Muscle atrophy in cachexia: can dietary protein tip the balance? [2011]
Effectiveness of Whey Protein Supplementation during Resistance Exercise Training on Skeletal Muscle Mass and Strength in Older People with Sarcopenia: A Systematic Review and Meta-Analysis. [2023]
Do multi-ingredient protein supplements augment resistance training-induced gains in skeletal muscle mass and strength? A systematic review and meta-analysis of 35 trials. [2022]
Effect of a high protein diet and/or resistance exercise on the preservation of fat free mass during weight loss in overweight and obese older adults: a randomized controlled trial. [2022]
Protein synthesis signaling in skeletal muscle is refractory to whey protein ingestion during a severe energy deficit evoked by prolonged exercise and caloric restriction. [2020]
Resistance exercise enhances myofibrillar protein synthesis with graded intakes of whey protein in older men. [2022]
Can supplemental protein to low-protein containing meals superimpose on resistance-training muscle adaptations in older adults? A randomized clinical trial. [2022]
Protein Recommendations for Weight Loss in Elite Athletes: A Focus on Body Composition and Performance. [2018]
The synergistic effect of protein complex supplementation combined with 12 weeks of resistance training on isokinetic muscular function in untrained young males. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Preexercise aminoacidemia and muscle protein synthesis after resistance exercise. [2022]
Effect of exercise on protein requirements. [2005]
12.United Statespubmed.ncbi.nlm.nih.gov
Effect of whey and soy protein supplementation combined with resistance training in young adults. [2022]
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