Effect of Local Food-Based Oral Nutritional Supplements (ONS) Containing Immunonutrients in the Form of Anthocyanin and Omega-3 on Nutritional Status and Inflammatory Response in Head and Neck Cancer Patients Receiving Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Body mass index (BMI)
研究概览
简要总结
The goal of this clinical trial is to compare the effect of local food-based oral nutritional supplements (ONS) containing immunonutrients (omega-3 and anthocyanins) on nutritional status and inflammatory response in head and neck cancer patients receiving radiotherapy. The main questions it aims to answer are:
- Is there any effect of local food-based oral nutritional supplements (ONS) containing immunonutrients (omega-3 and anthocyanins) on the nutritional status?
- Is there any effect of local food-based oral nutritional supplements (ONS) containing immunonutrients (omega-3 and anthocyanins) on inflammatory response?
Participants will participants will receive ONS in powder form ready to brew as much as 2 servings per day for 3 weeks.
Researchers will compare the effect of giving ONS containing immunonutrients compared to standard ONS to see the effect on nutritional status and inflammatory response
详细描述
The intervention group received ONS which contained immunonutrients with a composition consisting of purple sweet potato flour, egg white flour, whey protein, olive oil, omega 3 powder, sugar, and creamer. While the control group received a placebo in the form of standard ONS (isocaloric) with a composition of powdered skim milk, coconut oil, sugar, maltodextrin, and creamer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant diagnosed with advanced stage head and neck cancer (stages 3 and 4) who received radiotherapy, both as concurrent and adjuvant or chemoradiotherapy
- •Participant aged 18-80 years
- •Participant can consume food, either through a nasogastric tube (NGT) or orally
排除标准
- •Participant has a milk or egg allergy
- •Participant with comorbid renal impairment and/or diabetes mellitus
- •Participant with poor nutritional status with BMI < 17.0 kg/m2
研究组 & 干预措施
immunonutrients ONS
the intervention group received ONS which contained immunonutrients (omega 3 and anthocyanin)
干预措施: immunonutrients oral nutritional supplements (Dietary Supplement)
standard ONS
the control group received standard ONS (isocaloric)
干预措施: standard oral nutritional supplements (Dietary Supplement)
结局指标
主要结局
Body mass index (BMI)
时间窗: immediately after the intervention
Calculation of nutritional status using the ratio of body weight (kg) to height squared (m2), where body weight is measured using an digital scales Omron Type HBF 378 and height is measured with a stadiometer.
weight change
时间窗: immediately after the intervention
The differences in body weight after and before the intervention was given. Weight in kilograms will be measured with digital scales Omron Type HBF 378.
mid-upper arm circumference (MUAC)
时间窗: immediately after the intervention
the circumference of the left upper arm, measured at the mid-point between the tip of the shoulder and the tip of the elbow (olecranon process and the acromion). MUAC is measured using a metline in centimeters.
handgrip strength
时间窗: immediately after the intervention
a simple and reliable measurement of maximum voluntary muscle strength, that is measured with handgrip dynamometer in kilograms (kg) unit.
次要结局
未报告次要终点
研究者
Fuadiyah Nila Kurniasari
University of Brawijaya
University of Brawijaya