Biological Assessment of Clinical Nutrition and Its Application

NCT02102659 | Unknown DMC

• 1 other identifier: TJ-20130803
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Clinical nutritional support therapy is an important progress of modern medicine.
2. 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. 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. 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. 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. 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.

Conditions

Malnutrition

Keywords

Nutritional Assessment; Oral Epithelial Cell; Apoptosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Oral Mucosal Epithelial Cell Apoptosis Rate

  10 or 12 days

• Anthropometric measurements

  9 days

• The level of serum proteins

  9 days

Study Arms (2)

Upper Limit Nutrition Support Therapy

EXPERIMENTAL

"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

Formula Nutrition Support Therapy

ACTIVE COMPARATOR

"Formula nutrition support therapy" will be used in patens assigned in this group based on Harris Bendiest Formula.

Genetic: Formula Nutrition Support Therapy

Interventions

Upper Limit Nutrition Support Therapy GENETIC

"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

Also known as: Apoptosis rate of human oral epithelial cells

Upper Limit Nutrition Support Therapy

Formula Nutrition Support Therapy GENETIC

"Formula nutrition support therapy" will be used in patens assigned in this group based on Harris Bendiest Formula.

Formula Nutrition Support Therapy

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College in Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Related Publications (8)

• Studley HO. Percentage of weight loss: a basic indicator of surgical risk in patients with chronic peptic ulcer. 1936. Nutr Hosp. 2001 Jul-Aug;16(4):141-3; discussion 140-1. No abstract available.

  PMID: 11680474 BACKGROUND

• Schiesser M, Muller S, Kirchhoff P, Breitenstein S, Schafer M, Clavien PA. Assessment of a novel screening score for nutritional risk in predicting complications in gastro-intestinal surgery. Clin Nutr. 2008 Aug;27(4):565-70. doi: 10.1016/j.clnu.2008.01.010. Epub 2008 Mar 17.

  PMID: 18342995 BACKGROUND

• Norman K, Pichard C, Lochs H, Pirlich M. Prognostic impact of disease-related malnutrition. Clin Nutr. 2008 Feb;27(1):5-15. doi: 10.1016/j.clnu.2007.10.007. Epub 2007 Dec 3.

  PMID: 18061312 BACKGROUND

• Jones JS, Tidwell B, Travis J, Spencer T, Phillips P, Burford B. Nutritional support of the hospitalized patient: a team approach. J Miss State Med Assoc. 1995 Apr;36(4):91-9.

  PMID: 7776363 BACKGROUND

• Li C, Thompson CB. Cancer. DNA damage, deamidation, and death. Science. 2002 Nov 15;298(5597):1346-7. doi: 10.1126/science.1079168. No abstract available.

  PMID: 12434041 BACKGROUND

• Gong J, Traganos F, Darzynkiewicz Z. A selective procedure for DNA extraction from apoptotic cells applicable for gel electrophoresis and flow cytometry. Anal Biochem. 1994 May 1;218(2):314-9. doi: 10.1006/abio.1994.1184.

  PMID: 8074286 BACKGROUND

• Gao C, Hasan O, Wei X, Zou Y, Yin X, Tao D, Gong J. Assessment of nutritional status of clinical patients by determining normal range of oral mucosal apoptosis and proliferation rate. J Huazhong Univ Sci Technolog Med Sci. 2012 Oct;32(5):680-685. doi: 10.1007/s11596-012-1017-3. Epub 2012 Oct 18.

  PMID: 23073796 RESULT

• Luo X, Zhou Y, Tao D, Yu Y, Hu J, Qiu F, Kulkarni H, Gong J. Usefulness of oral mucosal epithelial cell apoptosis rate in nutritional assessment. Nutrition. 2006 Oct;22(10):1032-8. doi: 10.1016/j.nut.2006.03.016. Epub 2006 Sep 15.

  PMID: 16979323 RESULT

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Jianping Gong, M.D.,Ph.D.

  Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of General Surgery

Study Record Dates

• First Submitted: November 27, 2013
• First Posted: April 3, 2014
• Study Start: March 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: April 3, 2014

Record last verified: 2014-03

Locations

CN (1)