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CompletedNCT01538654EMFUpdated Oct 27, 2017

Enteroprotein Modified Fast ( EMF )

An observational study in Obesity, sponsored by M.D. Samir G. Sukkar. Completed at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-10-27.

Sponsored by M.D. Samir G. Sukkar · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
26
Ages
18 Years to 75 Years
Sex
All
01

Study 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
Read the 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.
02

Conditions studied

  • Obesity

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Keywords

  • 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
03

In context

Obesity

6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's enrollment of 26 is below the median of 132 across 1,338 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

This is the only study on the registry with M.D. Samir G. Sukkar as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients with BMI 30 - 45 Kg/m2

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
26 participants (actual)
Patient registry
No

Groups and cohorts

  • 'enteral protein tube feeding in obese

    protein sparing modified fast with a defined enteral formula by tube

    Procedure: enteral protein tube feeding in obese

Interventions

  • Procedureenteral 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

    Also known as: EMF ( enteral modified fast )

06

What researchers measure

Primary outcomes

  1. PSMF by tube feeding side effects

    Evaluation of side effects due to enteral nutrition by tube with a PSMF in obese subjects

    Time frame: at the day 10th /month for 6 months

07

Study locations

1 site
  • IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
    Genova, 16132, Italy
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2011 to primary completion in Dec 2012, 21 months.

Of 537 non-industry observational studies under Obesity, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 121. This study's 21 months is below that.

Counting every sponsor, half of 569 studies reached it within 40 months; a quarter within 19 and three quarters within 111.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 20, 2012
First posted
Feb 24, 2012
StartActual
Mar 10, 2011
Primary completionActual
Dec 20, 2012
CompletionActual
Dec 20, 2012
Last update
Oct 27, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01538654
Lead sponsor
M.D. Samir G. Sukkar
Collaborators
Nestlé Foundation
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) — Sponsor-investigator
First posted
Feb 24, 2012
Start date
Mar 10, 2011
Primary completion
Dec 20, 2012
Completion
Dec 20, 2012
Last update
Oct 27, 2017

Study contacts

Samir G Sukkar, MD
study director · IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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