Comparison of Per Kilogram and Nitrogen Balance Calculations for the Prediction of Daily Protein Requirement in Cancer Patients: a Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Change in Muscle Strength Based on Different Protein Calculation Methods
研究概览
简要总结
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
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cancer patients aged over 18 years
- •Patients admitted to the outpatient clinics of Istanbul University, Institute of Oncology, between September 2019 and January 2020
排除标准
- •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
研究组 & 干预措施
Per kg (PK)
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.
干预措施: a personalized diet plan was prepared according to the calculated requirements of each patient by two expert dietitians (Other)
Nitrogen Balance Equation (NBE)
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).
干预措施: a personalized diet plan was prepared according to the calculated requirements of each patient by two expert dietitians (Other)
结局指标
主要结局
Change in Muscle Strength Based on Different Protein Calculation Methods
时间窗: 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
时间窗: 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
时间窗: Baseline and 8 weeks
Improvement in nutritional status, evaluated using NRS-2002 scores from baseline to week 8.
次要结局
未报告次要终点
研究者
Mustafa Altınkaynak
Ass. Prof.
Istanbul University