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临床试验/CTRI/2024/10/074961
CTRI/2024/10/074961尚未招募不适用

Comparing nutrient intake and quality of life during the post-surgical recovery period in malnourished adults given either an oral nutritional supplement with dietary counselling or receiving dietary counselling alone

Dutch Medical Food1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年10月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To compare the effects of an oral nutritional supplement (ONS) taken with dietary counselling vs. dietary counselling alone among malnourished adults in laparoscopic post-surgical recovery period on the following:

研究概览

简要总结

Oral supplements can be crucial postoperative care by supporting recovery, providing essential nutrients, and promoting overall health. Adequate nutrition is essential for wound healing, tissue repair, and immune function after surgery. To compare the effects of Flex Compact an oral nutritional supplement (ONS) taken with dietary counselling vs. dietary counselling alone among malnourished adults in laparoscopic post-surgical recovery period on Energy consumption and Protein consumption. The secondary Objective is to compare the effects of an oral nutritional supplement (ONS) taken with dietary counselling vs. dietary counselling alone on total colorie intake, Serum Total Protein, Serum Albumin: Globulin (A/G) ratio, Quality of Life and Change in BMI. The Energy, protein and total food intake will be assessed at baseline, weeks 4, 8 and 12 using a 3-day recall food diary distributed by study personnel. Blood drawn at baseline and at the end of the study will be used to assess serum protein and ratio of serum albumin to globulin. Quality of life will be assessed at baseline, weeks 4, 8 and 12 using SF-36 questionnaire.  Compliance will be calculated as the amount of ONS consumed in proportion to prescribed calories and Safety will be assessed at baseline and at each visit until the end of the study.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
50.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Adults over 50 years with disease related malnourished adults who are post-op surgery.
  • Medium to a high degree of malnourishment, according to MUST.
  • The subject must be able to eat and drink.
  • The subject must be free living.
  • The subject must be able to provide informed consent.

排除标准

  • Subjects hospitalised for acute conditions impacting their metabolism.
  • Subjects with galactosemia or lactose intolerance.
  • Subjects with chronic kidney disease requiring dialysis.
  • Subjects taking other forms of nutritional support.
  • Subjects with dysphagia, malabsorption or related GI disorders, poorly controlled diabetes, active malignancies, or liver failure.
  • Subjects with any disease state resulting in abnormal (high) A/G ratio.
  • Subjects receiving end-of-life care.
  • Subjects participating in another clinical trial.
  • Subjects who are unable to provide informed consent.

结局指标

主要结局

To compare the effects of an oral nutritional supplement (ONS) taken with dietary counselling vs. dietary counselling alone among malnourished adults in laparoscopic post-surgical recovery period on the following:

时间窗: Day 0, Day 1, Day 28, Day 56, Day 84

1. Energy consumption

时间窗: Day 0, Day 1, Day 28, Day 56, Day 84

2. Protein consumption

时间窗: Day 0, Day 1, Day 28, Day 56, Day 84

次要结局

  • To compare the effects of an oral nutritional supplement (ONS) taken with dietary counselling vs. dietary counselling alone among laparoscopic post-surgical recovery period in malnourished adults on the following(1. Total food intake)

研究者

发起方
Dutch Medical Food
申办方类型
Other [neutraceuticals]
责任方
Principal Investigator
主要研究者

Dr R Jai Vinod Kumar

Apollo Speciality Hospitals Ayanambakkam Chennai

研究点 (1)

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