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Biological Assessment of Clinical Nutrition and Its Application

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ClinicalTrials.gov Identifier: NCT02102659
Recruitment Status : Unknown
Verified March 2014 by Jianping Gong, Huazhong University of Science and Technology.
Recruitment status was:  Active, not recruiting
First Posted : April 3, 2014
Last Update Posted : April 3, 2014
Sponsor:
Information provided by (Responsible Party):
Jianping Gong, Huazhong University of Science and Technology

Brief Summary:
  1. Clinical nutritional support therapy is an important progress of modern medicine.
  2. 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.
  3. 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.
  4. 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.
  5. 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".
  6. The patients applying for"upper 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.

Condition or disease Intervention/treatment Phase
Malnutrition Genetic: Upper Limit Nutrition Support Therapy Genetic: Formula Nutrition Support Therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 167 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : March 2014
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Upper Limit Nutrition Support Therapy
"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
"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
Other Name: Apoptosis rate of human oral epithelial cells

Active Comparator: Formula Nutrition Support Therapy
"Formula nutrition support therapy" will be used in patens assigned in this group based on Harris Bendiest Formula.
Genetic: Formula Nutrition Support Therapy
"Formula nutrition support therapy" will be used in patens assigned in this group based on Harris Bendiest Formula.




Primary Outcome Measures :
  1. The Length and Width of Surgical Incision Edema [ Time Frame: 2nd day ]
    The length and width of surgical incision edema will be measured by doppler ultrasonography in the 2nd day respectively after gastrointestinal operation.

  2. The Length and Width of Surgical Incision Edema [ Time Frame: 9th day ]
    The length and width of surgical incision edema will be measured by doppler ultrasonography in the 9th day respectively after gastrointestinal operation.


Secondary Outcome Measures :
  1. Oral Mucosal Epithelial Cell Apoptosis Rate [ Time Frame: 10 or 12 days ]
    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.

  2. Anthropometric measurements [ Time Frame: 9 days ]
    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..

  3. The level of serum proteins [ Time Frame: 9 days ]
    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.



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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients with Gastric cancer or colorectal cancer which confirmed by Preoperative pathology will be included.
  2. Patients who are diagnosed as malnutrition according history, physical examination and Nutrition Risk Screening 2002 will be included.
  3. patients who have digestive tract fistula because of operation complication will be included.
  4. patients who need fast track recovery after colorectal cancer operation will be included.

Exclusion Criteria:

  1. Patients who are diagnosed as Late stage (stage IV) gastric cancer or colorectal cancer and can not accomplish radical resection will be excluded.
  2. 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.
  3. patients with Severe endocrine system disease such as diabetic mellitus, hyperthyroidism will be excluded.
  4. patients with cardiac, renal, respiratory, or hepatic diseases, diabetes,active infection, evidence of sepsis, active bleeding or obstruction, and oral disease will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02102659


Locations
China, Hubei
Tongji Hospital, Tongji Medical College in Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Sponsors and Collaborators
Huazhong University of Science and Technology
Investigators
Principal Investigator: Jianping Gong, M.D.,Ph.D. Huazhong University of Science and Technology

Publications of Results:
Other Publications:
Responsible Party: Jianping Gong, Director of Department of General Surgery, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT02102659     History of Changes
Other Study ID Numbers: TJ-20130803
First Posted: April 3, 2014    Key Record Dates
Last Update Posted: April 3, 2014
Last Verified: March 2014

Keywords provided by Jianping Gong, Huazhong University of Science and Technology:
Nutritional Assessment
Oral Epithelial Cell
Apoptosis

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders