MalnutritionNCT02102659

Biological Assessment of Clinical Nutrition and Its Application

A study testing Upper Limit Nutrition Support Therapy and Formula Nutrition Support Therapy in people with Malnutrition, run by Huazhong University of Science and Technology at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 16 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Malnutrition
What is being tested?: Upper Limit Nutrition Support Therapy and Formula Nutrition Support Therapy
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 167 participants
Where: 1 siteChina
Study dates: Mar 2014to Nov 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 to 80 years
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Tongji Hospital, Tongji Medical College in Huazhong University of Science and Technology
Wuhan, Hubei, 430030

Other trials in China

About this study

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.

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 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
Being tested: Upper Limit Nutrition Support Therapy, Formula Nutrition Support Therapy
Keywords: Nutritional Assessment, Oral Epithelial Cell, Apoptosis
Medical subject headings: Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Upper Limit Nutrition Support TherapyGenetic
Also called Apoptosis rate of human oral epithelial cells
"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
Formula Nutrition Support TherapyGenetic
"Formula nutrition support therapy" will be used in patens assigned in this group based on Harris Bendiest Formula.

Study groups in NCT02102659
Study group	Role	What they receive
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. Receives: 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. Receives: Genetic: Formula Nutrition Support Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 9th day

Secondary outcomes (3)

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.
Measured: 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..
Measured: 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.
Measured: 9 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2014Nov 2015

First posted3 Apr 2014 (estimated)
Study startMar 2014
Primary completionNov 2015 (estimated)
Study completionNov 2015 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for MalnutritionStudies of the same condition, open and under way.
More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 167 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02102659
Sponsor's protocol ID: TJ-20130803
Status last verified: Mar 2014
First submitted: 27 Nov 2013
Last updated: 3 Apr 2014
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 11680474
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.
PubMed 18342995
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.
PubMed 18061312
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.
PubMed 7776363
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.
PubMed 12434041
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.
PubMed 8074286
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.
PubMed 23073796
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.
PubMed 16979323

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Active, not recruitingPhase 2
Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
Environmental Enteric Dysfunction (EED), Stunting
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
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All Malnutrition trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT02102659
Acronym / sponsor ID: TJ-20130803
Conditions: Malnutrition
Keywords: Nutritional Assessment, Oral Epithelial Cell, Apoptosis
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 167 participants (estimated)
Lead sponsor: Huazhong University of Science and TechnologyUniversity, hospital or other
Study start: Mar 2014
Primary completion: Nov 2015 (estimated)
Study completion: Nov 2015 (estimated)
First posted: 3 Apr 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Upper Limit Nutrition Support Therapy	Experimental	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.
Formula Nutrition Support Therapy	Active comparator	Genetic: Formula Nutrition Support Therapy"Formula nutrition support therapy" will be used in patens assigned in this group based on Harris Bendiest Formula.

Who may qualify

Ages: 16 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Upper Limit Nutrition Support TherapyAlso: Apoptosis rate of human oral epithelial cells"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"Formula nutrition support therapy" will be used in patens assigned in this group based on Harris Bendiest Formula.	Genetic	Formula Nutrition Support Therapy

Primary outcome

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.
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.

3 secondary outcomes

Oral Mucosal Epithelial Cell Apoptosis Rate
Time frame: 10 or 12 days
Anthropometric measurements
Time frame: 9 days
The level of serum proteins
Time frame: 9 days

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2014.
Background: PubMed 11680474Studley 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.
Background: PubMed 18342995Schiesser 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.
Background: PubMed 18061312Norman 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.
Background: PubMed 7776363Jones 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.
Background: PubMed 12434041Li 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.
Background: PubMed 8074286Gong 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.
Results publication: PubMed 23073796Gao 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.
Results publication: PubMed 16979323Luo 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.

Related trials for Malnutrition

RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Active, not recruitingPhase 2
Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
Environmental Enteric Dysfunction (EED), Stunting
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jianping Gong, M.D.,Ph.D. principal investigator

Huazhong University of Science and Technology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Upper Limit Nutrition Support Therapy and Formula Nutrition Support Therapy in people with Malnutrition, run by Huazhong University of Science and Technology at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Length and Width of Surgical Incision Edema (time frame: 2nd day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02102659, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2014.