Nutritional SupportNCT03400046
The Correlation Between Nutrients and Muscle Mass
An observational study of Nutritional Support and Muscle Loss, run by Jinling Hospital, China.
Trial summary
Patients who are suffer from CIF often develop muscle wasting because of hypercatabolism.The relationship between different nutrition support formulas and lean body mass is still unclear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nutritional Support, Muscle Loss
- What is being tested?
- Nutritional Product Supplementation
- How many people
- 223 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2013to 30 Sep 2017
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated at a single clinical nutrition center of a tertiary referral hospital in China to investigate the relationship between nutrients and muscle mass in CIF patients. The data used were accumulated at the center between September 2013 and September 2017.
Who may be able to join
- All adult CIF patients (age ≥18 years) receiving nutrition support were included
Who cannot join
- Hepatic insufficiency (alanine transaminase/aspartate transaminase ratio 200% above normal range or bilirubin >3 mg/dL), renal insufficiency (serum creatinine [Scr] >1.5 mg/dL), acute or life-threatening diseases (e.g., shock, collapse, stroke, coma of unknown etiology, or recent cardiac infarction), and pregnant or breast-feeding women
About this study
Official title: The Correlation Between Nutritional Support Regimens and Muscle Mass in Patients With Chronic Intestinal Failure
Patients who are suffer from CIF often develop muscle wasting because of hypercatabolism.The relationship between different nutrition support formulas and lean body mass is still unclear. The purpose of this study is to investigate the relationship between nutrition support and muscle mass and attempt to find the nutrients which will benefit lean body mass in patients with CIF.
Read the detailed description
Chronic intestinal failure (CIF) is defined as the malabsorption and nutrients deficiency mainly caused by severe gastrointestinal benign diseases such as intestinal fistula, short bowel, and mechanical obstruction and some malignant diseases such as end-stage intra-abdominal or pelvic cancers . CIF is one of the rarest of organ failures all over the world and patients suffer from CIF often requires a prolonged time to recover . Hypercatabolism caused by diseases stress, inflammation and reduced nutrient intake indicates that patients with CIF need long-term nutritional support .
Patients who are suffer from CIF often develop muscle wasting because of hypercatabolism. Moreover, studies showed that low muscle mass and muscle wasting during critical illness are associated with poor clinical outcomes and hampered rehabilitation. Except Resistance training, sufficient nutrients supplement also play important roles in maintaining the skeletal muscle mass. Guidelines recommended that nutritional support regimens in patients should be individualized and adjusted over time based on formal nutritional assessment . However, almost all guidelines only recommended the total energy and protein requirements based on the results of basal metabolic rate (BMR) and nitrogen balance rather than the lean body mass . The relationship between different nutrition support formulas and lean body mass is still unclear.
The purpose of this study is to investigate the relationship between nutrition support and muscle mass and attempt to find the nutrients which will benefit lean body mass in patients with CIF.
All adult CIF patients (age ≥18 years) receiving nutrition support were included. The exclusion criteria were hepatic insufficiency (alanine transaminase/aspartate transaminase ratio 200% above normal range or bilirubin >3 mg/dL), renal insufficiency (serum creatinine [Scr] >1.5 mg/dL), acute or life-threatening diseases (e.g., shock, collapse, stroke, coma of unknown etiology, or recent cardiac infarction), and pregnant or breast-feeding women. The study was approved by the ethics committee of Jinling Hospital, Medical School of Nanjing University.
The lean body mass include soft lean mass (SLM), skeletal muscle mass (SMM) and fat free mass (FFM) which were measured and recorded by body composition analyzer (InBody S10, Biospace) at the time of admission and discharge respectively.The deviation of lean body mass was calculated by the difference between admission and discharge, and then symbolized as ∆SLM, ∆SMM and ∆FFM. Basic and nutritional information of CIF patients was measured weekly after hospital admission, including age, sex, BMI, NRS-2002 score, SGA grade, etiology of malnutrition, daily energy \& protein intake via EN \& PN.
- Conditions
- Nutritional Support, Muscle Loss
- Being tested
- Nutritional Product Supplementation
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional Product SupplementationDrug
Patients with chronic intestinal failure were administered nutritional support including enteral and parenteral nutrition.
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition
soft lean mass/skeletal muscle mass/fat free mass
Measured: From date of patients enrollment until the date of patients discharge from hospital, assessed up to 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start1 Sep 2013
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nutritional SupportStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Xinying, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400046
- Sponsor's protocol ID
- 201502022-4
- Status last verified
- Jan 2018
- First submitted
- 9 Jan 2018
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
[1] Bielawska B, Allard JP: Parenteral Nutrition and Intestinal Failure. Nutrients 2017, 9. [2] Pironi L, Arends J, Bozzetti F, Cuerda C, Gillanders L, Jeppesen PB, Joly F, Kelly D, Lal S, Staun M, Szczepanek K, Van Gossum A, Wanten G, Schneider SM: ESPEN guidelines on chronic intestinal failure in adults. Clinical nutrition 2016, 35:247-307. [3] Pironi L: Definitions of intestinal failure and the short bowel syndrome. Best Pract Res Clin Gastroenterol 2016, 30:173-85. [4] Feinberg J, Nielsen EE, Korang SK, Halberg Engell K, Nielsen MS, Zhang K, Didriksen M, Lund L, Lindahl N, Hallum S, Liang N, Xiong W, Yang X, Brunsgaard P, Garioud A, Safi S, Lindschou J, Kondrup J, Gluud C, Jakobsen JC: Nutrition support in hospitalised adults at nutritional risk. The Cochrane database of systematic reviews 2017, 5:Cd011598. [5] Taylor BE, McClave SA, Martindale RG, Warren MM, Johnson DR, Braunschweig C, McCarthy MS, Davanos E, Rice TW, Cresci GA, Gervasio JM, Sacks GS, Roberts PR, Compher C, Society of Critical Care M, the American Society of P, Enteral N: Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). Crit Care Med 2016, 44:390-438. [6] McClave SA, DiBaise JK, Mullin GE, Martindale RG: ACG Clinical Guideline: Nutrition Therapy in the Adult Hospitalized Patient. Am J Gastroenterol 2016, 111:315-34.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between Nutritional Support Regimens and Muscle Mass in Patients With Chronic Intestinal Failure
- ClinicalTrials.gov ID
- NCT03400046
- Acronym / sponsor ID
- 201502022-4
- Conditions
- Nutritional Support, Muscle Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 17 Jan 2018 (actual)
- 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.
Patients who are suffer from CIF often develop muscle wasting because of hypercatabolism.The relationship between different nutrition support formulas and lean body mass is still unclear. The purpose of this study is to investigate the relationship between nutrition support and muscle mass and attempt to find the nutrients which will benefit lean body mass in patients with CIF.
Detailed description
Chronic intestinal failure (CIF) is defined as the malabsorption and nutrients deficiency mainly caused by severe gastrointestinal benign diseases such as intestinal fistula, short bowel, and mechanical obstruction and some malignant diseases such as end-stage intra-abdominal or pelvic cancers . CIF is one of the rarest of organ failures all over the world and patients suffer from CIF often requires a prolonged time to recover . Hypercatabolism caused by diseases stress, inflammation and reduced nutrient intake indicates that patients with CIF need long-term nutritional support .
Patients who are suffer from CIF often develop muscle wasting because of hypercatabolism. Moreover, studies showed that low muscle mass and muscle wasting during critical illness are associated with poor clinical outcomes and hampered rehabilitation. Except Resistance training, sufficient nutrients supplement also play important roles in maintaining the skeletal muscle mass. Guidelines recommended that nutritional support regimens in patients should be individualized and adjusted over time based on formal nutritional assessment . However, almost all guidelines only recommended the total energy and protein requirements based on the results of basal metabolic rate (BMR) and nitrogen balance rather than the lean body mass . The relationship between different nutrition support formulas and lean body mass is still unclear.
The purpose of this study is to investigate the relationship between nutrition support and muscle mass and attempt to find the nutrients which will benefit lean body mass in patients with CIF.
All adult CIF patients (age ≥18 years) receiving nutrition support were included. The exclusion criteria were hepatic insufficiency (alanine transaminase/aspartate transaminase ratio 200% above normal range or bilirubin >3 mg/dL), renal insufficiency (serum creatinine [Scr] >1.5 mg/dL), acute or life-threatening diseases (e.g., shock, collapse, stroke, coma of unknown etiology, or recent cardiac infarction), and pregnant or breast-feeding women. The study was approved by the ethics committee of Jinling Hospital, Medical School of Nanjing University.
The lean body mass include soft lean mass (SLM), skeletal muscle mass (SMM) and fat free mass (FFM) which were measured and recorded by body composition analyzer (InBody S10, Biospace) at the time of admission and discharge respectively.The deviation of lean body mass was calculated by the difference between admission and discharge, and then symbolized as ∆SLM, ∆SMM and ∆FFM. Basic and nutritional information of CIF patients was measured weekly after hospital admission, including age, sex, BMI, NRS-2002 score, SGA grade, etiology of malnutrition, daily energy \& protein intake via EN \& PN.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated at a single clinical nutrition center of a tertiary referral hospital in China to investigate the relationship between nutrients and muscle mass in CIF patients. The data used were accumulated at the center between September 2013 and September 2017.
Key inclusion criteria (1 listed)
- All adult CIF patients (age ≥18 years) receiving nutrition support were included
Key exclusion criteria (1 listed)
- Hepatic insufficiency (alanine transaminase/aspartate transaminase ratio 200% above normal range or bilirubin >3 mg/dL), renal insufficiency (serum creatinine [Scr] >1.5 mg/dL), acute or life-threatening diseases (e.g., shock, collapse, stroke, coma of unknown etiology, or recent cardiac infarction), and pregnant or breast-feeding women
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 |
|---|---|---|
| Nutritional Product SupplementationPatients with chronic intestinal failure were administered nutritional support including enteral and parenteral nutrition. | Drug | – |
Primary outcome
Body composition
Time frame: From date of patients enrollment until the date of patients discharge from hospital, assessed up to 2 months.
soft lean mass/skeletal muscle mass/fat free mass
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- Background[1] Bielawska B, Allard JP: Parenteral Nutrition and Intestinal Failure. Nutrients 2017, 9. [2] Pironi L, Arends J, Bozzetti F, Cuerda C, Gillanders L, Jeppesen PB, Joly F, Kelly D, Lal S, Staun M, Szczepanek K, Van Gossum A, Wanten G, Schneider SM: ESPEN guidelines on chronic intestinal failure in adults. Clinical nutrition 2016, 35:247-307. [3] Pironi L: Definitions of intestinal failure and the short bowel syndrome. Best Pract Res Clin Gastroenterol 2016, 30:173-85. [4] Feinberg J, Nielsen EE, Korang SK, Halberg Engell K, Nielsen MS, Zhang K, Didriksen M, Lund L, Lindahl N, Hallum S, Liang N, Xiong W, Yang X, Brunsgaard P, Garioud A, Safi S, Lindschou J, Kondrup J, Gluud C, Jakobsen JC: Nutrition support in hospitalised adults at nutritional risk. The Cochrane database of systematic reviews 2017, 5:Cd011598. [5] Taylor BE, McClave SA, Martindale RG, Warren MM, Johnson DR, Braunschweig C, McCarthy MS, Davanos E, Rice TW, Cresci GA, Gervasio JM, Sacks GS, Roberts PR, Compher C, Society of Critical Care M, the American Society of P, Enteral N: Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). Crit Care Med 2016, 44:390-438. [6] McClave SA, DiBaise JK, Mullin GE, Martindale RG: ACG Clinical Guideline: Nutrition Therapy in the Adult Hospitalized Patient. Am J Gastroenterol 2016, 111:315-34.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutritional Support and Muscle Loss, run by Jinling Hospital, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Body composition (time frame: From date of patients enrollment until the date of patients discharge from hospital, assessed up to 2 months.). 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 NCT03400046, which also lists 1 linked publication.
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 17 Jan 2018.