Nitrogen BalanceNCT06824636
Per Kilogram Versus Nitrogen Balance Methods for Daily Protein Requirement in Cancer Patients
A study testing a personalized diet plan was prepared according to the calculated requirements of each patient by two expert dietitians in people with Nitrogen Balance and Cancer, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nitrogen Balance, Cancer, Protein Requirement
- What is being tested?
- a personalized diet plan was prepared according to the calculated requirements of each patient by two expert dietitians
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2019to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer patients aged over 18 years
- Patients admitted to the outpatient clinics of Istanbul University, Institute of Oncology, between September 2019 and January 2020
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Per Kilogram and Nitrogen Balance Calculations for the Prediction of Daily Protein Requirement in Cancer Patients: A Prospective Randomized Controlled Study
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:
Read more
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
Read the detailed description
Materials and Methods
Study Population: Cancer patients over 18 years of age, who were admitted to the outpatient clinics of Istanbul University, Institute of Oncology, between September 2019 and January 2020, were included. Informed written consent was obtained from all participants prior to the study. Exclusion criteria were: age below 18, inability to feed orally (due to dementia, impaired consciousness, dysphagia, etc.), dialysis dependence, psychiatric and/or eating disorders, and those on home parenteral nutrition.
Malnutrition Risk ScreeningMalnutrition (MN) risk was screened using the Nutritional Risk Screening 2002 (NRS-2002) tool. Patients with an NRS-2002 score ≥3 were considered at risk of malnutrition.
Assessment of Daily Energy and Protein RequirementsDaily energy requirements (DER) were estimated by adding activity and stress factors to the basal energy requirement calculated using the Harris-Benedict equation. The daily protein requirement was determined using the PK method in one group and the NBE method in the other, with a 1:1 allocation ratio. The PK group received 1.2-1.5 g/kg/day of protein. The NBE group recorded their food intake and collected 24-hour urine samples for nitrogen balance calculation. Nitrogen balance was calculated by subtracting daily nitrogen excretion (urinary urea/2.14 + 3 g from feces) from nitrogen intake (24-hour protein consumption [g]/6.25). The predicted daily protein requirement in the NBE group was calculated as daily nitrogen loss x 6.25 (g protein).
Personalized Diet Plan and Follow-UpA personalized diet plan was prepared for all patients according to their calculated requirements by two expert dietitians from Istanbul University, Istanbul Faculty of Medicine, Clinical Nutrition Team. Oral enteral nutrition products were added if dietary intake was insufficient to meet daily calorie and/or protein needs. Follow-up visits were conducted at the 4th and 8th weeks post-admission. Each visit included assessments of nutritional status, food consumption, BMI, muscle mass, muscle strength, gait speed, serum albumin, and C-reactive protein (CRP).
Measurements of Anthropometrics, Muscle Strength, and Physical PerformanceAnthropometric measurements were performed using bioelectrical impedance analysis (BIA) (Tanita MC 780 MA, Japan) to assess body weight, fat-free mass (FFM), fat ratio, total body water (TBW), bone weight, and visceral adiposity index. BMI was calculated as weight in kilograms divided by height in meters squared. Muscle strength (kg) was measured using a handheld dynamometer (Jamar, USA), with three repetitions per hand, and the highest measurement from the dominant hand was used. Gait speed (m/s) was assessed using a 4-meter walk test. All measurements were conducted by two nurses from Istanbul University, Istanbul Faculty of Medicine, Clinical Nutrition Team.
Physical Exercise PlanModerate-intensity aerobic exercise (brisk walking) for at least 30 minutes per day, 5 days a week, was planned for each patient by a physiotherapist from the Physical Therapy and Rehabilitation Department.
- Conditions
- Nitrogen Balance, Cancer, Protein Requirement
- Being tested
- a personalized diet plan was prepared according to the calculated requirements of each patient by two expert dietitians
- Keywords
- Cancer, Protein, Diet, Physical performance
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a personalized diet plan was prepared according to the calculated requirements of each patient by two expert dietitiansOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: a personalized diet plan was prepared according to the calculated requirements of each patient by two expert dietitians |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Muscle Strength Based on Different Protein Calculation Methods
Change in muscle strength from baseline to week 8, measured by a handheld dynamometer.
Measured: 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).
Measured: 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.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start1 Sep 2019
- Primary completion30 Jan 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nitrogen BalanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Altınkaynak, Istanbul University
- Investigators
- Bulent Saka, Professor, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824636
- Sponsor's protocol ID
- 158299-2019
- Status last verified
- Feb 2025
- First submitted
- 4 Feb 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Per Kilogram and Nitrogen Balance Calculations for the Prediction of Daily Protein Requirement in Cancer Patients: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06824636
- Acronym / sponsor ID
- 158299-2019
- Conditions
- Nitrogen Balance, Cancer, Protein Requirement
- Keywords
- Cancer, Protein, Diet, Physical performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Materials and Methods
Study Population: Cancer patients over 18 years of age, who were admitted to the outpatient clinics of Istanbul University, Institute of Oncology, between September 2019 and January 2020, were included. Informed written consent was obtained from all participants prior to the study. Exclusion criteria were: age below 18, inability to feed orally (due to dementia, impaired consciousness, dysphagia, etc.), dialysis dependence, psychiatric and/or eating disorders, and those on home parenteral nutrition.
Malnutrition Risk ScreeningMalnutrition (MN) risk was screened using the Nutritional Risk Screening 2002 (NRS-2002) tool. Patients with an NRS-2002 score ≥3 were considered at risk of malnutrition.
Assessment of Daily Energy and Protein RequirementsDaily energy requirements (DER) were estimated by adding activity and stress factors to the basal energy requirement calculated using the Harris-Benedict equation. The daily protein requirement was determined using the PK method in one group and the NBE method in the other, with a 1:1 allocation ratio. The PK group received 1.2-1.5 g/kg/day of protein. The NBE group recorded their food intake and collected 24-hour urine samples for nitrogen balance calculation. Nitrogen balance was calculated by subtracting daily nitrogen excretion (urinary urea/2.14 + 3 g from feces) from nitrogen intake (24-hour protein consumption [g]/6.25). The predicted daily protein requirement in the NBE group was calculated as daily nitrogen loss x 6.25 (g protein).
Personalized Diet Plan and Follow-UpA personalized diet plan was prepared for all patients according to their calculated requirements by two expert dietitians from Istanbul University, Istanbul Faculty of Medicine, Clinical Nutrition Team. Oral enteral nutrition products were added if dietary intake was insufficient to meet daily calorie and/or protein needs. Follow-up visits were conducted at the 4th and 8th weeks post-admission. Each visit included assessments of nutritional status, food consumption, BMI, muscle mass, muscle strength, gait speed, serum albumin, and C-reactive protein (CRP).
Measurements of Anthropometrics, Muscle Strength, and Physical PerformanceAnthropometric measurements were performed using bioelectrical impedance analysis (BIA) (Tanita MC 780 MA, Japan) to assess body weight, fat-free mass (FFM), fat ratio, total body water (TBW), bone weight, and visceral adiposity index. BMI was calculated as weight in kilograms divided by height in meters squared. Muscle strength (kg) was measured using a handheld dynamometer (Jamar, USA), with three repetitions per hand, and the highest measurement from the dominant hand was used. Gait speed (m/s) was assessed using a 4-meter walk test. All measurements were conducted by two nurses from Istanbul University, Istanbul Faculty of Medicine, Clinical Nutrition Team.
Physical Exercise PlanModerate-intensity aerobic exercise (brisk walking) for at least 30 minutes per day, 5 days a week, was planned for each patient by a physiotherapist from the Physical Therapy and Rehabilitation Department.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Per kg (PK) | Active comparator | Other: a personalized diet plan was prepared according to the calculated requirements of each patient by two expert dietitiansDaily 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. |
| Nitrogen Balance Equation (NBE) | Active comparator | Other: a personalized diet plan was prepared according to the calculated requirements of each patient by two expert dietitiansPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cancer patients aged over 18 years
- Patients admitted to the outpatient clinics of Istanbul University, Institute of Oncology, between September 2019 and January 2020
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a personalized diet plan was prepared according to the calculated requirements of each patient by two expert dietitiansOral 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. | Other | Nitrogen Balance Equation (NBE), Per kg (PK) |
Primary outcome
Change in Muscle Strength Based on Different Protein Calculation Methods
Time frame: Baseline and 8 weeks
Change in muscle strength from baseline to week 8, measured by a handheld dynamometer.
Change in Lean Body Mass Based on Different Protein Calculation Methods
Time frame: Baseline and 8 weeks
Change in lean body mass from baseline to week 8, assessed via bioelectrical impedance analysis (BIA).
Change in Nutritional Status Based on Different Protein Calculation Methods
Time frame: Baseline and 8 weeks
Improvement in nutritional status, evaluated using NRS-2002 scores from baseline to week 8.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bulent Saka, Professor principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a personalized diet plan was prepared according to the calculated requirements of each patient by two expert dietitians in people with Nitrogen Balance and Cancer, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Muscle Strength Based on Different Protein Calculation Methods (time frame: Baseline and 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025; AzTrials last refreshed its copy on 26 Oct 2026.