Effect of Whey protein isolate based nutritional supplement in CABG patients

Not Applicable

• Conditions: Health Condition 1: I52- Other heart disorders in diseasesclassified elsewhere

• Registration Number: CTRI/2023/08/056773
• Lead Sponsor: Otsuka Pharmaceutical India Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Patients with age of = 18 to 70 years and with the clinical diagnosis of CAD (coronary artery disease) undergoing CABG surgery.

2. Patients/LAR who are willing to provide voluntary written informed consent to participate in the study.

3. Patients receiving nutrition as per standard care.

4. Expected length of ICU/hospital stay is minimum 5 days.

5. Patients who in the opinion of physician are suitable to receive oral WPI based nutritional supplement.

6. Patients who will be able to adhere to study visit schedule and other protocol requirements.

After the screening and confirmation, the patient will receive Whey Protein Isolate based nutritional supplement 24-48 hrs. after the CABG surgery based on discretion of physician/dietician for 30 days

Exclusion Criteria

1. Patients taking enteral (tube feeding) or parenteral nutritional supplements or any other form of protein supplement.

2. Patients having known allergy or contraindication for use of WPI based nutritional supplements.

3. Pregnant or breastfeeding women.

4.Patients with BMI >30 kg/m2.

5. Patient with severe and life-threatening complication(s) or patients who are unlikely to survive the next 48-72 hrs. at the time of enrollment (as per physician’s discretion).

6. Patients using other experimental drugs or participating in other clinical trial in the prior one month.

7. Any clinical condition that would preclude participation in the study as per investigator’s opinion.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Adequacy of total calories and protein intake for the study period <br/ ><br>2. Change in weight (kg) from baseline to EOS (30 ± 2 days) <br/ ><br>3. Change in hand grip strength from baseline to EOS (30 ± 2 days)Timepoint: Endpoint 1: Visit 1 (24-48 hrs. post-surgery/WPI based nutritional supplement initiation) to EOS (At 30 ± 2 days from start of WPI based nutritional supplement) <br/ ><br> <br/ ><br>Endpoint 2: Baseline (Pre-surgery/Day of Admission, <br/ ><br>Day -3 to Day 0) to EOS (30 ± 2 days) <br/ ><br> <br/ ><br>Endpoint 3: Baseline to EOS (30 ± 2 days)

Secondary Outcome Measures

Name	Time	Method
1. Safety assessment: AE (if any) will be recorded on AE formTimepoint: Visit 1 (24-48 hrs. post-surgery/WPI based nutritional supplement initiation) to EOS (At 30 ± 2 days from start of WPI based nutritional supplement);2. Change in nutritional status of patient using SGA from baseline to end of studyTimepoint: Baseline (Pre-surgery/Day of Admission, Day -3 to Day 0) to EOS (30 ± 2 days);3. Patient & Physician experience with the WPI based nutritional supplementTimepoint: At the time of discharge from the hospital & EOS (30 ± 2 days);4. Patient compliance to WPI based nutritional supplementTimepoint: At the time of discharge from ICU, discharge from hospital to EOS (30 ± 2 days);5. Improvement in QoLTimepoint: Baseline to EOS