Protein Supplement for Frailty in Heart Surgery Patients

(PROTECT-CS Trial)

Recruiting at 1 trial location

Overseen By Rakesh Arora, BKin,MD,PhD,

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: St. Boniface Hospital

Disqualifiers: Class IV symptoms, Cirrhosis, Cognitive impairment, others

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 5 9 10 11}

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

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.

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.

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

Group I: Protein Supplementation Experimental Treatment 1 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 Supplementation Placebo Group 1 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).

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

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]

Insufficient protein intake can lead to muscle loss and functional decline, especially in older adults, particularly during periods of inactivity like hospitalization.

Supplementing with approximately 30 grams of protein and 3 grams of leucine can help stimulate muscle protein synthesis in older adults, potentially improving muscle health during times of reduced activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The importance of dietary protein for muscle health in inactive, hospitalized older adults. Thalacker-Mercer, AE., Drummond, MJ.[2018]

In a study of 268 elderly patients (ages 61-75) undergoing surgery for gastroduodenal diseases, the use of a specialized protein composite mixture enriched with calcium significantly improved nutritional markers and helped prevent protein-energy deficiency (BEN) in 79.1% of patients.

In contrast, only 32.6% of patients in the control group, who did not receive the calcium-enriched mixture, showed similar protective effects, highlighting the efficacy of this nutritional intervention in postoperative rehabilitation.

NCBI (Pubmed)

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.] Baranovsky, AY., Kruglova, NA.[2022]

Higher protein intake (1.0-1.2 g/kg/day) is recommended for healthy older adults to support muscle health, with benefits seen from evenly distributing protein intake across meals.

Supplementation with vitamin D (800-1000 IU) and omega-3 fatty acids (around 3 g/day) may enhance muscle mass, strength, and physical function, especially in those with low vitamin D levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Update on Protein, Leucine, Omega-3 Fatty Acids, and Vitamin D in the Prevention and Treatment of Sarcopenia and Functional Decline. Tessier, AJ., Chevalier, S.[2018]

In a study of 200 community-dwelling older adults, frailty status was linked to protein intake, with frail individuals consuming less protein and branched-chain amino acids (BCAAs) compared to robust and pre-frail participants.

The relationship between frailty and protein consumption varied depending on the assessment tool used, indicating that the modified Fried's frailty phenotype (mFP) was particularly sensitive in identifying lower protein intake in frail older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protein-Related Dietary Parameters and Frailty Status in Older Community-Dwellers across Different Frailty Instruments. Coelho-Júnior, HJ., Calvani, R., Picca, A., et al.[2020]

A specially-formulated composition of essential amino acids (HiEAA) significantly enhances protein synthesis in older individuals with heart failure compared to a popular protein-based meal replacement (LoEAA), with more than double the anabolic response (p < 0.001).

The HiEAA formulation not only suppresses protein breakdown more effectively (p < 0.001) but also offers a low-calorie option, making it beneficial for heart failure patients who often struggle with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Kim, IY., Park, S., Smeets, ETHC., et al.[2020]

Whey protein supplementation (WPS) was well tolerated and significantly increased daily protein intake in a study of 47 frail, hospitalized elderly individuals.

Participants receiving WPS showed notable improvements in grip strength and knee extensor force compared to the control group, indicating that WPS can enhance rehabilitation outcomes in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whey Protein Supplementation Improves Rehabilitation Outcomes in Hospitalized Geriatric Patients: A Double Blinded, Randomized Controlled Trial. Niccoli, S., Kolobov, A., Bon, T., et al.[2018]

In a study of 120 older adults, both exercise and BCAA supplementation significantly reduced frailty, with the greatest improvement seen in the combined exercise and BCAA group (β= -1.73, p<0.001).

Exercise alone also effectively decreased frailty (β= -1.68, p<0.001), highlighting its importance as a primary strategy for improving health and quality of life in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based exercise and nutritional interventions to improve frailty syndrome among older adults: A quasi-experimental study. Chen, LF., Chang, HC., Cai, ZC., et al.[2023]

A strength training program combined with a protein-rich supplement improved the daily life status of frail elderly patients (aged 80-90) after hospitalization, indicating potential benefits for home health care.

While the impact of the protein supplement on muscle strength was unclear, the overall positive changes in daily living activities suggest that such programs could be beneficial for elderly patients transitioning from hospital to home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Three-case reports--a program of strength training for home health care on frail elderly patients with protein rich supplement just after the training]. Iijima, S., Kurokawa, E., Masaki, K., et al.[2010]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

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]

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

Protein Nutritional Status and Frailty: A Mendelian Randomization Study. [2023]

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

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

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

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]

6. Switzerland pubmed.ncbi.nlm.nih.gov

An Update on Protein, Leucine, Omega-3 Fatty Acids, and Vitamin D in the Prevention and Treatment of Sarcopenia and Functional Decline. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Protein-Related Dietary Parameters and Frailty Status in Older Community-Dwellers across Different Frailty Instruments. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

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]

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

Whey Protein Supplementation Improves Rehabilitation Outcomes in Hospitalized Geriatric Patients: A Double Blinded, Randomized Controlled Trial. [2018]

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

Community-based exercise and nutritional interventions to improve frailty syndrome among older adults: A quasi-experimental study. [2023]

11. Japan pubmed.ncbi.nlm.nih.gov

[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]