Enteroprotein Modified Fast ( EMF )

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Nestlé Foundation
Information provided by (Responsible Party):
M.D. Samir G. Sukkar, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
ClinicalTrials.gov Identifier:
NCT01538654
First received: February 20, 2012
Last updated: February 23, 2012
Last verified: February 2012
  Purpose

The purposes of the esperience is:

  1. to verify the safety of protein sparing modified fast(PSMF) by enteral route ( EMF )performed in cycles of ten days/months for six months
  2. to compare EMF with oral PSMF clinically ( appetite control, fat freemass mantainance, polmonary function tests and metabolic pattern)
  3. to verify the weight mantainance after 6 months from the treatment suspension

Condition Intervention Phase
Obesity
Procedure: enteral protein tube feeding in obese patients
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Enteroprotein Modified Fast ( EMF ) : Clinical Safety and Efficacy. A Six Months Pilot RCT

Resource links provided by NLM:


Further study details as provided by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy:

Primary Outcome Measures:
  • PSMF by tube feeding side effects [ Time Frame: at the day 10th /month for 6 months ] [ Designated as safety issue: Yes ]
    Evaluation of side effects due to enteral nutrition by tube with a PSMF in obese subjects


Estimated Enrollment: 30
Study Start Date: March 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: enteral protein sparing modified fast
protein sparing modified fast with a defined enteral formula by tube
Procedure: enteral protein tube feeding in obese patients
The intervention is rapresened by a new alternative to treate obese patients by mean of a protein sparing modified fast administered by continous 24 h enteral feeding Vs oral protein sparing modified fast feeding
Other Name: EMF ( enteral modified fast )
Active Comparator: oral protein sparing modified fast
protein sparing modified fast wtih a defined oral formula
Procedure: enteral protein tube feeding in obese patients
The intervention is rapresened by a new alternative to treate obese patients by mean of a protein sparing modified fast administered by continous 24 h enteral feeding Vs oral protein sparing modified fast feeding
Other Name: EMF ( enteral modified fast )

Detailed Description:

Rationale A) primary endpoint

  1. to verify the safety of protein sparing modified fast by enteral route ( EMF )in cycles of ten days/months repeated for six months,
  2. To compare EMF with oral PSMF clinically ( appetite control, polmonary function tests and metabolic pattern) and on metabolic parameters (hypertension, glucose intolerance, dyslipidaemia) maintaining body composition (particularly fat free mass and muscular strength) in 15 patients with disease-causing obesity not responding to medical treatment and/or cognitive/behavioural therapy, who are candidates for invasive treatment such as the gastric balloon or surgery but do not intend to undergo them compared with 15 undergoing the same regimen without the naso-gastric tube. To verify the effects of treatment with regard to the enteral-hormonal structure during the acute phase (selected sub-group) and while undergoing treatment.

B) Secondary endpoints:

  1. To verify the percentage of patients who maintain the weight reached 6 months after stopping treatment with the naso-gastric tube associated with a high-calorie normal-protein diet.
  2. Verify clinical safety of EN in these patients.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • both genders, outpatients
  • aged between 16 and 75
  • with BMI 30 - 45 Kg/m2
  • that are not in a restricted diet since at least 3 months
  • with obesity related comorbidities (- type 2 diabetes
  • mild or moderate OSAS
  • orthopedic diseases (coxarthrosis, gonarthrosis)
  • hypertension
  • non alcoholic hepatic steatosis
  • accepting to be enrolled in the study (signing informed consent)

Exclusion Criteria:

  • Presence of gastrointestinal diseases
  • Presence of cancer
  • Patients treated with gastrolesive or anticoagulant drugs
  • Hepatic failure, renal failure or multi-organ failure (cut off)
  • Contraindications for enteral nutrition,Mechanical bowel complete, or partial chronic obstruction
  • Severe mesenteric ischemia not caused by hypovolemia
  • Digiunal or ileal fistula with high output (400 mL/die)
  • Severe modifications of the intestinal function caused by enteropathies or insufficient absorbent surface, to the point that a normal nutritional state cannot be maintained
  • Type 1 diabetes
  • Type 2 diabetes treated with oral or injected drugs that may cause hypoglycemia
  • ANBN: anorexia or bulimia nervosa, evaluation of other symptoms by specific tests
  • Patients with major psychiatric disorders or not cooperative, or with alcohol or drug addiction disorders.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01538654

Contacts
Contact: Samir G Sukkar, MD +39-10-5553985 samir.sukkar@hsanmartino.it
Contact: Claudia Borrini, MD +39-10-5553986

Locations
Italy
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy Recruiting
Genova, Italy, 16132
Contact: Claudia Borrini, MD    00390105553985    claudia.borrini@gmail.com   
Sponsors and Collaborators
M.D. Samir G. Sukkar
Nestlé Foundation
Investigators
Study Director: Samir G Sukkar, MD IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
  More Information

No publications provided

Responsible Party: M.D. Samir G. Sukkar, Chief Clinical Nutrition Unit, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
ClinicalTrials.gov Identifier: NCT01538654     History of Changes
Other Study ID Numbers: EMF2011
Study First Received: February 20, 2012
Last Updated: February 23, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy:
obesity
PSMF ( protein sparing modified fast)
Enteral nutrition
Tube feeding
VLCD ( very low calorie diet)
Pulmonary function tests
body composition
FFM ( fat free mass)
Body fat
Handgripstregth

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014