Enteroprotein Modified Fast ( EMF ) (EMF)

Enteroprotein Modified Fast ( EMF ) : Clinical Safety and Efficacy. A Six Months Pilot RCT

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

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: 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
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with BMI 30 - 45 Kg/m2

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: EMF ( enteral modified fast )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSMF by tube feeding side effects	Evaluation of side effects due to enteral nutrition by tube with a PSMF in obese subjects	at the day 10th /month for 6 months

Collaborators and Investigators

• Sponsor: M.D. Samir G. Sukkar
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 10, 2011
• Primary Completion (ACTUAL): December 20, 2012
• Study Completion (ACTUAL): December 20, 2012

Study Registration Dates

• First Submitted: February 20, 2012
• First Submitted That Met QC Criteria: February 23, 2012
• First Posted (ESTIMATE): February 24, 2012

Study Record Updates

• Last Update Posted (ACTUAL): October 27, 2017
• Last Update Submitted That Met QC Criteria: October 25, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: obesity; body composition; Enteral nutrition; Tube feeding; Body fat; PSMF ( protein sparing modified fast); VLCD ( very low calorie diet); Pulmonary function tests; FFM ( fat free mass); Handgripstregth
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: EMF2011