NCT01538654

Brief Summary

The purposes of the esperience is:

  1. 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. 2.to compare EMF with oral PSMF clinically ( appetite control, fat freemass mantainance, polmonary function tests and metabolic pattern)
  3. 3.to verify the weight mantainance after 6 months from the treatment suspension

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2011

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2012

Completed
Last Updated

October 27, 2017

Status Verified

October 1, 2017

Enrollment Period

1.8 years

First QC Date

February 20, 2012

Last Update Submit

October 25, 2017

Conditions

Obesity

Keywords

obesityPSMF ( protein sparing modified fast)Enteral nutritionTube feedingVLCD ( very low calorie diet)Pulmonary function testsbody compositionFFM ( fat free mass)Body fatHandgripstregth

Outcome Measures

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

    at the day 10th /month for 6 months

Study Arms (1)

'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

enteral protein tube feeding in obesePROCEDURE

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 )
'enteral protein tube feeding in obese

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with BMI 30 - 45 Kg/m2

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Genova, 16132, Italy

Location

MeSH Terms

Conditions

Obesity

Interventions

AdiposityElectromagnetic Fields

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Body Fat DistributionBody Weights and MeasuresBody ConstitutionPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisBody CompositionBiochemical PhenomenaChemical PhenomenaMetabolismPhysiological PhenomenaElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaMagnetic Fields

Study Officials

  • Samir G Sukkar, MD

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

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief Clinical Nutrition Unit

Study Record Dates

First Submitted

February 20, 2012

First Posted

February 24, 2012

Study Start

March 10, 2011

Primary Completion

December 20, 2012

Study Completion

December 20, 2012

Last Updated

October 27, 2017

Record last verified: 2017-10

Locations

IT(1)