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Enteroprotein Modified Fast ( EMF ) (EMF)

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ClinicalTrials.gov Identifier: NCT01538654
Recruitment Status : Completed
First Posted : February 24, 2012
Last Update Posted : October 27, 2017
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

Brief Summary:

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 or disease Intervention/treatment
Obesity Procedure: enteral protein tube feeding in obese

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.

Study Type : Observational
Actual Enrollment : 26 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Enteroprotein Modified Fast ( EMF ) : Clinical Safety and Efficacy. A Six Months Pilot RCT
Actual Study Start Date : March 10, 2011
Actual Primary Completion Date : December 20, 2012
Actual Study Completion Date : December 20, 2012

Group/Cohort Intervention/treatment
'enteral protein tube feeding in obese
protein sparing modified fast with a defined enteral formula by tube
Procedure: enteral protein tube feeding in obese
The intervention is represented by a new alternative to treat obese patients by means of a protein sparing modified fast administered by continous 24 h enteral feeding
Other Name: EMF ( enteral modified fast )



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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with BMI 30 - 45 Kg/m2
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.

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): NCT01538654


Locations
Italy
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Genova, Italy, 16132
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

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
First Posted: February 24, 2012    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017

Keywords provided by M.D. Samir G. Sukkar, 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