Biological Assessment of Clinical Nutrition and Its Application

Study Overview
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Brief Summary
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Clinical nutritional support therapy is an important progress of modern medicine. Conventional methods of clinical nutrition assessment (Anthropometric, lab, etc.) not just lack of accuracy and immediacy but also difficult to dynamically reflect the fluctuation trend of nutrition status. It has been reported that malnutrition affects proliferation and apoptosis of human cells in vivo. This preliminary study was initiated by the hypothesis that changes in nutritional status may be reflected rapidly in fast proliferating cells. In the previous studies the investigators already found that apoptosis rate of oral mucosal epithelium could reflect changes in nutritional status.There were an obvious decreasing in apoptosis and proliferation rate of oral mucosal epithelium in malnourished patients. Based on the patient's curve of apoptosis rate of oral mucosal epithelium, the plateau being achieved by increase the nutrition amount continuously, Maintain this amount of nutrition given until the end of treatment. The investigators call this amount of nutrition the upper limit nutrition support therapy. The patients applying forupper limit nutrition support therapy and Formula nutrition support therapy separately, comparing of the two methods influences on postoperative wound healing, postoperative complication rate ,inflammatory response, side effects of chemotherapy, hospital stays and hospitalization expenses.

Official Title
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This Preliminary Study Was Designed to Explore a New Biological Method for Nutritional Assessment by Measuring Oral Mucosal Epithelial Cell Apoptosis Rate and Guideline to Clinical Nutrition Support Therapy for Improving Clinical Outcome of Malnourished Patients.

Conditions
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Malnutrition

Intervention / Treatment
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* Genetic: Upper Limit Nutrition Support Therapy
* Genetic: Formula Nutrition Support Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Gastric cancer or colorectal cancer which confirmed by Preoperative pathology will be included. Patients who are diagnosed as malnutrition according history, physical examination and Nutrition Risk Screening 2002 will be included. patients who have digestive tract fistula because of operation complication will be included. patients who need fast track recovery after colorectal cancer operation will be included. Exclusion Criteria: Patients who are diagnosed as Late stage (stage IV) gastric cancer or colorectal cancer and can not accomplish radical resection will be excluded. Postoperative gastric cancer or colorectal cancer patients who is Unable to tolerate the chemotherapy or unable to complete the whole chemotherapy course will be excluded. patients with Severe endocrine system disease such as diabetic mellitus, hyperthyroidism will be excluded. patients with cardiac, renal, respiratory, or hepatic diseases, diabetes,active infection, evidence of sepsis, active bleeding or obstruction, and oral disease will be excluded.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Upper Limit Nutrition Support Therapy<br>Upper limit nutrition support therapy will be used in patens assigned to this group based on the patient's curve of apoptosis of oral mucosal epithelium. | Genetic: Upper Limit Nutrition Support Therapy<br>* Upper limit nutrition support therapy will be used in patens assigned to this group based on the patient's curve of apoptosis of oral mucosal epithelium<br>* Other names: Apoptosis rate of human oral epithelial cells;|
| Active Comparator: Formula Nutrition Support Therapy<br>Formula nutrition support therapy will be used in patens assigned in this group based on Harris Bendiest Formula. | Genetic: Formula Nutrition Support Therapy<br>* Formula nutrition support therapy will be used in patens assigned in this group based on Harris Bendiest Formula.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Length and Width of Surgical Incision Edema | The length and width of surgical incision edema will be measured by doppler ultrasonography in the 2nd day respectively after gastrointestinal operation. | 2nd day | 
| The Length and Width of Surgical Incision Edema | The length and width of surgical incision edema will be measured by doppler ultrasonography in the 9th day respectively after gastrointestinal operation. | 9th day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral Mucosal Epithelial Cell Apoptosis Rate | Oral mucosal epithelial cell samples will be collected in the every morning before tooth brushing teeth for 9 days after gastrointestinal operation..The cells well be analyzed by flow cytometry for detecting apoptosis rate. | 10 or 12 days | 
| Anthropometric measurements | Anthropometric measurements including weight, body mass index, triceps skinfold thickness, and midarm muscle circumference will be recorded every 2-3 days days for 9 days after gastrointestinal operation.. | 9 days | 
| The level of serum proteins | The serum proteins including retinol-binding protein (RBP), transferrin, prealbumin (PA), and albumin will be measured every 2-3 days for 9 days after gastrointestinal operation. | 9 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutritional Assessment, Oral Epithelial Cell, Apoptosis