MedTrace Logo

Per Kilogram Versus Nitrogen Balance Methods for Daily Protein Requirement in Cancer Patients

NCT06824636 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2025-02-13

No results posted yet for this study

Summary

The goal of this study is to compare the effects of two dietary protein supplementation methods (per kg \[PK\] vs nitrogen balance equation \[NBE\]) on nutritional status, muscle strength, lean body mass, physical performance, and dietary compliance in cancer patients.

The main questions it aims to answer are:

Does the PK method improve muscle strength and lean body mass more effectively than the NBE method?

Which method better supports nutritional status and physical performance in cancer patients?

Are there differences in dietary compliance between the two methods?

Researchers will compare the PK method (1.2-1.5 g/kg/day protein) to the NBE method (protein requirements based on nitrogen balance) to evaluate their impact on these outcomes.

Participants will:

Follow a personalized diet plan based on either the PK or NBE method

Attend follow-up visits at weeks 4 and 8 for assessments of BMI, muscle mass, muscle strength, gait speed, serum albumin, and CRP

Engage in moderate aerobic exercise (brisk walking) for at least 30 minutes a day, 5 days a week

Conditions

  • Nitrogen Balance
  • Cancer
  • Protein Requirement

Interventions

OTHER

a personalized diet plan was prepared according to the calculated requirements of each patient by two expert dietitians

Oral enteral nutrition products were added to the diet if the daily calorie and/or protein requirements could not be met by the diet. All of the patients underwent follow-up visits (4th and 8th weeks) after the initial assessment on admission. Each visit (0, 4th and 8th weeks) included screening of the nutritional status and food consumption, and measurements of body mass index (BMI), muscle mass, muscle strength, gait speed, serum albumin and serum C-reactive protein (CRP). Anthropometric measurements, muscle strength, physical performance, and the physical exercise plan were assessed.

Sponsors & Collaborators

  • Istanbul University

    lead OTHER

Principal Investigators

  • Bulent Saka, Professor · Istanbul University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2020-01-30
Completion
2020-03-30

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06824636 on ClinicalTrials.gov