Recruiting

Protein

Sponsor:

St. Boniface Hospital

Code:

NCT04038294

Conditions

Frail Older Adult Syndrome

Nutrition Poor

Cardiovascular Morbidity

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

ISOlution protein supplement

Placebo Supplement

Study Details

Brief summary:

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.

Conditions

Frail Older Adult Syndrome

Nutrition Poor

Cardiovascular Morbidity

Study ID

NCT04038294

Start date

Feb 12, 2020

Status verified date

Dec, 2023

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Dec 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patients aged 60 years of age or older, undergoing elective isolated CABG, aortic valve repair or replacement for moderate aortic stenosis or severe regurgitation, mitral valve repair or replacement for moderate stenosis or severe regurgitation or combined CABG/valve procedures.
2. Patients with a Clinical Frailty Score (CFS) from 3 (Managing Well) to 7 (severely frail),
3. Patients with a Short Physical Performance Battery (SPPB) score of 9 or less, or an SF-36 (PF) score of <= 60
4. Patients with an estimated wait time for elective cardiac surgery of 1 week or longer
5. Inpatients with an estimated wait time for non-emergent cardiac surgery of 2 days or longer from hospital admission

Exclusion Criteria:

1. Decompensated or non-ambulatory class IV symptoms of angina, dyspnea, claudication
2. Patients with a Clinical Frailty Score (CFS) of 7 or greater (Severely frail to terminally ill); this will exclude less than 1% of the population on the elective cardiac surgery waitlist.
3. Creatinine clearance <30 mL/min/1.83 m2
4. Cirrhosis (Child-Pugh Class B or greater)
5. Allergy to milk proteins or other ingredients in the supplement
6. Inability to safely ingest beverage by mouth
7. Significant cognitive impairment (MoCA Score < 16)
8. An inability to speak/read in English or French
9. Non-emergent or emergent surgery less than 2 days from hospital admission

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Protein Supplementation

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).

placebo comparator: Placebo Supplementation

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).

Interventions

ISOlution protein supplement

EXPERIMENTAL ARM: Protein supplement 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.

Placebo Supplement

PLACEBO COMPARATOR ARM: Placebo supplement 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

Primary outcome measure

  • Change in Short-Form 36 physical Function (PF) score [ Time Frame: Assessed at: baseline, Day of Discharge from Hospital after cardiac surgery, 2 months post surgery and 6 months post surgery ]

Central Contacts and Locations

Central contacts

Rakesh Arora, BKin,MD,PhD,

204-258-1078rarora@sbgh.mb.ca

David Kent, BKin, MSc

204-237-2985dkent@sbgh.mb.ca

Locations

St. Boniface General Hospital

Recruiting

Winnipeg, Manitoba, Canada, R2H2A6

Contacts

Rakesh Arora, MD,PhD

(204) 258-1078rarora@sbgh.mb.ca

David Kent, MSc

204-237-2985dkent@sbgh.mb.ca

Principal Investigator:

Rakesh C Arora, MD, PhD

More Information

Sponsor

St. Boniface Hospital

Last update posted

Dec 18, 2023

Last verified

Dec, 2023

Keywords

  • Cardiac Surgery
  • Protein supplementation
  • Pre-Frail and Frail older adults

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Boniface Hospital on 2023-12-18.