Clinical trial · Interventional
Per Kilogram Versus Nitrogen Balance Methods for Daily Protein Requirement in Cancer Patients
Comparison of Per Kilogram and Nitrogen Balance Calculations for the Prediction of Daily Protein Requirement in Cancer Patients: A Prospective Randomized Controlled Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Nitrogen Balance | — | UNRESOLVED | — |
| Protein Requirement | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| a personalized diet plan was prepared according to the calculated requirements of each patient by two expert dietitians | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Per kg (PK)
- description
- 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.
- interventionNames
- Other: a personalized diet plan was prepared according to the calculated requirements of each patient by two expert dietitians
- type
- ACTIVE_COMPARATOR
- label
- Nitrogen Balance Equation (NBE)
- description
- 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).
- interventionNames
- Other: a personalized diet plan was prepared according to the calculated requirements of each patient by two expert dietitians
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Cancer patients aged over 18 years Patients admitted to the outpatient clinics of Istanbul University, Institute of Oncology, between September 2019 and January 2020 Exclusion Criteria: 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
References
Publications (0)
Data not yet available