150 Participants Needed

Protein Supplement for Frailty in Heart Surgery Patients

(PROTECT-CS Trial)

Recruiting at 1 trial location
DK
RA
Overseen ByRakesh Arora, BKin,MD,PhD,
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: St. Boniface Hospital

Trial Summary

Do I need to stop my current medications for the trial?

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 ISOlution protein supplement for frailty in heart surgery patients?

Research suggests that better protein nutritional status can help prevent frailty, and protein supplements have been shown to improve muscle health and recovery in older adults, especially during periods of inactivity like hospitalization.12345

Is the protein supplement safe for humans?

The protein supplements, including those rich in leucine, have been generally well tolerated in studies involving older adults, including those with heart failure and frailty, suggesting they are safe for human use.678910

How is the ISOlution protein supplement treatment different from other treatments for frailty in heart surgery patients?

The ISOlution protein supplement is unique because it is a leucine-rich protein supplement, which may help improve muscle strength and rehabilitation outcomes in frail patients, similar to how whey protein has been shown to benefit elderly patients in rehabilitation settings.1591011

What is the purpose of this trial?

Heart disease in an aging population has resulted in heart surgery being offered to older and more frail patients. Frail patients which make up more than 50% of patients currently undergoing heart surgery are vulnerable to having long-recovery times after surgery, greater loss of independence (i.e. being admitted to a nursing home), experience more depression and anxiety, and have a worse quality of life. In fact, nearly 10% of frail, older adult patients die within 30 days after their heart surgery. The Investigators previous study found that weight-loss and poor muscle strength (i.e. weakness) of frail patients can lead to a worse recovery after heart surgery. Furthermore, inadequate nutrition (aka. malnutrition which is defined as an unintentional, nutritional intake imbalance (not necessarily a decreased intake) before an operation can lead to a vicious cycle of muscle loss causing more frailty, a desire to eat less leading to more muscle loss and increased frailty. At present there is no process to address this important issue in older adults undergoing heart surgery. The Investigators propose to study a practical, real-world, treatment plan that focuses on good nutrition to prevent muscle loss and reduced frailty in vulnerable heart surgery patients.

Research Team

RA

Rakesh Arora, BKin,MD,PhD

Principal Investigator

University of Manitoba

Eligibility Criteria

This trial is for patients aged 60 or older who are frail and waiting for non-emergency heart surgery. They must be able to drink by mouth, speak/read English or French, have a Clinical Frailty Score of 3-6, and an SPPB score ≤9 or SF-36 (PF) score ≤60. Excluded are those with severe cognitive impairment, kidney issues, liver cirrhosis, milk protein allergies, or very severe symptoms.

Inclusion Criteria

I am 60 or older and scheduled for specific heart surgery.
I am 60 or older and having surgery for heart valve issues or bypass.
My wait time for elective heart surgery is at least 1 week.
See 3 more

Exclusion Criteria

Significant cognitive impairment (MoCA Score < 16)
I have severe heart or lung symptoms that limit my daily activities.
I had surgery within 2 days of being admitted to the hospital.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgery Nutrition

Participants receive carbohydrate supplements to help with nausea symptoms, glycemic control, and GI function, and leucine-rich protein supplements for up to 2 weeks prior to surgery.

2 weeks

Post-operative Recovery

Participants receive leucine-rich protein supplements during post-operative recovery in the hospital.

6 days
In-hospital stay

Post-discharge Nutrition

Participants continue to receive leucine-rich protein supplements for 8 weeks following hospital discharge.

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 2 and 6 months post-surgery.

6 months

Treatment Details

Interventions

  • ISOlution protein supplement
  • Placebo Supplement
Trial Overview The study tests if the ISOlution protein supplement can help frail older adults recover better after heart surgery compared to a placebo. It aims to prevent muscle loss and reduce frailty by improving nutrition in these vulnerable patients before their operation.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Protein SupplementationExperimental Treatment1 Intervention
The intended intervention consists of a leucine-rich protein-caloric supplement provided by the Enhanced Medical Nutrition®. The product contains 25 g protein and 3 g Leucine per serving (total caloric value: 160 Kcal.) to be re-constituted and consumed twice daily for a minimum of 2 weeks pre-procedure, twice daily during post-operative recovery and 2 times daily for 8 weeks after the patient is discharged home (Appendix A).
Group II: Placebo SupplementationPlacebo Group1 Intervention
Enrolled patients allocated to the control group will receive the same supplementation schedule as well as compliance verification; however, they will receive a placebo product with no supplemented protein (no nutritional benefit).

Find a Clinic Near You

Who Is Running the Clinical Trial?

St. Boniface Hospital

Lead Sponsor

Trials
55
Recruited
15,000+

Heart and Stroke Foundation of Canada

Collaborator

Trials
131
Recruited
72,600+

Findings from Research

The systematic review and meta-analysis focused on the relationship between protein consumption and frailty in older adults, highlighting the importance of adequate protein intake for maintaining health in this population.
Findings suggest that higher protein consumption may be associated with reduced frailty, indicating that dietary protein could play a crucial role in promoting better health outcomes for older adults.
Reply to Grant, W.B. Comment on "Coelho-Junior et al. Protein Intake and Frailty in Older Adults: A Systematic Review and Meta-Analysis of Observational Studies. Nutrients 2022, 14, 2767".Coelho-Junior, HJ., Calvani, R., Picca, A., et al.[2023]
A Mendelian randomization study involving 356,432 individuals found that higher serum total protein levels are significantly associated with a lower risk of frailty, suggesting that better protein nutritional status may help prevent frailty.
While serum albumin levels did not show a significant association with frailty in the overall sample, a preventive effect was observed in women, indicating that protein status may have gender-specific effects on frailty risk.
Protein Nutritional Status and Frailty: A Mendelian Randomization Study.Tomata, Y., Wang, Y., Hägg, S., et al.[2023]
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.
Provision of high-protein supplement for patients recovering from hip fracture.Neumann, M., Friedmann, J., Roy, MA., et al.[2022]

References

Reply to Grant, W.B. Comment on "Coelho-Junior et al. Protein Intake and Frailty in Older Adults: A Systematic Review and Meta-Analysis of Observational Studies. Nutrients 2022, 14, 2767". [2023]
Protein Nutritional Status and Frailty: A Mendelian Randomization Study. [2023]
Provision of high-protein supplement for patients recovering from hip fracture. [2022]
The importance of dietary protein for muscle health in inactive, hospitalized older adults. [2018]
5.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[A specialized product of therapeutic nutrition is a dry protein composite mixture enriched with calcium of dairy origin, in the postoperative rehabilitation of elderly and senile patients.] [2022]
An Update on Protein, Leucine, Omega-3 Fatty Acids, and Vitamin D in the Prevention and Treatment of Sarcopenia and Functional Decline. [2018]
Protein-Related Dietary Parameters and Frailty Status in Older Community-Dwellers across Different Frailty Instruments. [2020]
Consumption of a Specially-Formulated Mixture of Essential Amino Acids Promotes Gain in Whole-Body Protein to a Greater Extent than a Complete Meal Replacement in Older Women with Heart Failure. [2020]
Whey Protein Supplementation Improves Rehabilitation Outcomes in Hospitalized Geriatric Patients: A Double Blinded, Randomized Controlled Trial. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Community-based exercise and nutritional interventions to improve frailty syndrome among older adults: A quasi-experimental study. [2023]
[Three-case reports--a program of strength training for home health care on frail elderly patients with protein rich supplement just after the training]. [2010]
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