Ignite Creation Date:
2024-10-25 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570174
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-18
Brief Title:
Oral Protein Supplements for Nutritional and Quality of Life Improvement After Pancreatic Resection in Elderly Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Oral Protein Supplements Might Improve Nutritional Status and Quality of Life in Elderly Patients After Standard Pancreatic Resection
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study investigates the effects of oral protein supplements on the nutritional status and quality of life in elderly patients following standard pancreatic resection The research aims to determine whether these supplements can improve protein intake and contribute to better skeletal muscle mass which is critical for recovery and overall health The study hypothesizes that higher compliance with protein supplementation will be positively correlated with increased protein intake and improved muscle mass index potentially leading to enhanced postoperative outcomes in this patient population
Detailed Description:
This study was a randomized double-blind placebo-controlled clinical trial conducted to assess the effects of oral protein supplements on nutritional status and quality of life in elderly patients following pancreaticobiliary surgery The study included elderly patients aged 65 years or older who underwent surgery for pancreaticobiliary cancer The trial was conducted between January 7 2021 and July 18 2022
A total of 60 patients were initially enrolled but after 19 dropouts the final analysis was based on 41 patients 18 in the placebo group and 23 in the experimental group The experimental group received protein supplements providing 18g of protein per day while the control group received a placebo containing carbohydrates instead of protein
Key outcomes such as nutrient intake nutritional status quality of life muscle mass muscle strength and 10-meter gait speed were measured at three time points before surgery at discharge and during an outpatient visit The data were analyzed using a Linear Mixed-Effects Model to evaluate the effects of the intervention
A total of 60 patients were initially enrolled but after 19 dropouts the final analysis was based on 41 patients 18 in the placebo group and 23 in the experimental group The experimental group received protein supplements providing 18g of protein per day while the control group received a placebo containing carbohydrates instead of protein
Key outcomes such as nutrient intake nutritional status quality of life muscle mass muscle strength and 10-meter gait speed were measured at three time points before surgery at discharge and during an outpatient visit The data were analyzed using a Linear Mixed-Effects Model to evaluate the effects of the intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None