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

NCT06824636 | Completed

• 1 other identifier: 158299-2019
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cancer; Protein; Diet; Physical performance

Outcome Measures

Primary Outcomes (3)

• Change in Muscle Strength Based on Different Protein Calculation Methods

  Change in muscle strength from baseline to week 8, measured by a handheld dynamometer.

  Baseline and 8 weeks

• Change in Lean Body Mass Based on Different Protein Calculation Methods

  Change in lean body mass from baseline to week 8, assessed via bioelectrical impedance analysis (BIA).

  Baseline and 8 weeks

• Change in Nutritional Status Based on Different Protein Calculation Methods

  Improvement in nutritional status, evaluated using NRS-2002 scores from baseline to week 8.

  Baseline and 8 weeks

Study Arms (2)

Per kg (PK)

ACTIVE COMPARATOR

Daily protein requirement was determined by PK in the first group and by NBE in the second group. Patients in the PK group received 1.2-1.5 g/kg/day of protein.

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

Nitrogen Balance Equation (NBE)

ACTIVE COMPARATOR

Patients in the NBE group were asked to record their food consumption and to collect a 24-hour urine sample on the same day for nitrogen balance calculation. Nitrogen balance was calculated by subtracting the amount of nitrogen excreted daily (urinary urea/2.14 + 3 g excreted in faeces) from the amount of nitrogen intake (24-h protein consumption \[g\]/6.25). The predicted daily protein requirement in the NBE group was calculated with daily nitrogen loss x 6.25 (g protein).

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

Interventions

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

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.

Nitrogen Balance Equation (NBE); Per kg (PK)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cancer patients aged over 18 years
• Patients admitted to the outpatient clinics of Istanbul University, Institute of Oncology, between September 2019 and January 2020

You may not qualify if:

• Patients aged below 18 years
• Patients unable to feed orally (such as those with dementia, impaired consciousness, dysphagia, etc.)
• Dialysis patients
• Patients with psychiatric and/or eating disorders
• Patients receiving home parenteral nutrition

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Bulent Saka, Professor

  Istanbul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Prof.

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 13, 2025
• Study Start: September 1, 2019
• Primary Completion: January 30, 2020
• Study Completion: March 30, 2020
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)