Enteroprotein Modified Fast ( EMF )
This study is currently recruiting participants.
Verified February 2012 by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Sponsor:
M.D. Samir G. Sukkar
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purposes of the esperience is:
- to verify the safety of protein sparing modified fast(PSMF) by enteral route ( EMF )performed in cycles of ten days/months for six months
- to compare EMF with oral PSMF clinically ( appetite control, fat freemass mantainance, polmonary function tests and metabolic pattern)
- 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
- to verify the safety of protein sparing modified fast by enteral route ( EMF )in cycles of ten days/months repeated for six months,
- 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:
- 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.
- 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
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 May 23, 2013