search
Back to results

Medical Supervised Duodenal-Enteral Feeding Treatment

Primary Purpose

Obesity, Obesity, Visceral, Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Nasogastroduodenal Protocol
Control
Data analysis
Sponsored by
BiomediKcal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, overweight, fat percentage, body fat, enteral feeding, fat loss

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- Desire for weight loss, desire to improve body image, voluntariness

Exclusion Criteria:

- esophageal alteration or swallowing, not sign the informed consent, acute active disease

Sites / Locations

  • BiomediKcal - Advanced Medical Nutrition & Lifestyle Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Nasogastroduodenal Protocol

Controls

Data analysis

Arm Description

Evaluation of a protocol for the treatment of excess body fat through duodenal nutrition

Change from Baseline Body Composition values at 1 and 3 months

Analysis and publication of data

Outcomes

Primary Outcome Measures

Weightloss
Decrease, minor difference in weight at the end of treatment

Secondary Outcome Measures

Fat loss
Decrease, minor difference in percentage of fat at the end of treatment
Loss of measures
Decrease of measurements in perimeters (arm, waist, hip, thigh)

Full Information

First Posted
April 26, 2018
Last Updated
July 9, 2019
Sponsor
BiomediKcal
Collaborators
University of Alicante, Universidad Miguel Hernandez de Elche
search

1. Study Identification

Unique Protocol Identification Number
NCT03542864
Brief Title
Medical Supervised Duodenal-Enteral Feeding Treatment
Official Title
Medical Supervised Duodenal-Enteral Feeding for Overweight, Obesity and Increased Body Fat Percentage Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
August 3, 2017 (Actual)
Primary Completion Date
December 23, 2018 (Actual)
Study Completion Date
January 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
BiomediKcal
Collaborators
University of Alicante, Universidad Miguel Hernandez de Elche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Medical Supervised Duodenal-Enteral Feeding for Overweight, Obesity and Increased Body Fat Percentage Treatment based on an intervention procedure performed by a Licensed Nutritionist Doctor for weight loss and loss of fat percentage in patients who need it.
Detailed Description
Medical Supervised Duodenal-Enteral Feeding for Overweight, Obesity and Increased Body Fat Percentage Treatment based on an intervention procedure performed by a Licensed Nutritionist Doctor for weight loss and loss of fat percentage in patients who need it. The feeding is by nasogastric-duodenal tube depending on the desired fat loss and / or weight in relation to the basal metabolism. Feeding by tube of 12-29 days, continuing with personalized nutritional treatment for 2 weeks and physical activity during the protocol. Losses of weight and / or expected fat greater than 10%. The results will be compared with bariatric surgery. The main objective is to provide a tool for the obesity epidemic that can be applied worldwide by doctors without the complications of surgery and with a lower price for health systems and controlling the actions of the hormones leptin and ghrelin.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Obesity, Visceral, Overweight and Obesity, Body Fat Disorder, Feeding and Eating Disorders, Hormone Disturbance, Weight Loss
Keywords
obesity, overweight, fat percentage, body fat, enteral feeding, fat loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Duodenal-Enteral medical supervised feeding response
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nasogastroduodenal Protocol
Arm Type
Experimental
Arm Description
Evaluation of a protocol for the treatment of excess body fat through duodenal nutrition
Arm Title
Controls
Arm Type
Active Comparator
Arm Description
Change from Baseline Body Composition values at 1 and 3 months
Arm Title
Data analysis
Arm Type
Other
Arm Description
Analysis and publication of data
Intervention Type
Dietary Supplement
Intervention Name(s)
Nasogastroduodenal Protocol
Other Intervention Name(s)
Medical-Clinical-Nutrition assessment
Intervention Description
Complete nutrition (carbohydrates, lipids, proteins, vitamins, oligoelements)
Intervention Type
Other
Intervention Name(s)
Control
Other Intervention Name(s)
Progress
Intervention Description
Progress registration of body composition values
Intervention Type
Other
Intervention Name(s)
Data analysis
Other Intervention Name(s)
Statistics
Intervention Description
Statistical analysis of all data
Primary Outcome Measure Information:
Title
Weightloss
Description
Decrease, minor difference in weight at the end of treatment
Time Frame
Change from Baseline weight at 1 and 3 months
Secondary Outcome Measure Information:
Title
Fat loss
Description
Decrease, minor difference in percentage of fat at the end of treatment
Time Frame
Change from Baseline fat percentage at 1 and 3 months
Title
Loss of measures
Description
Decrease of measurements in perimeters (arm, waist, hip, thigh)
Time Frame
Change from Baseline measures at 1 and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Desire for weight loss, desire to improve body image, voluntariness Exclusion Criteria: - esophageal alteration or swallowing, not sign the informed consent, acute active disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isaac Kuzmar, Dr
Organizational Affiliation
BiomediKcal - Advanced Medical Nutrition & Lifestyle Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
BiomediKcal - Advanced Medical Nutrition & Lifestyle Center
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080020
Country
Colombia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Only available for scientific journal review process
Citations:
PubMed Identifier
25101227
Citation
Kuzmar I, Rizo M, Cortes-Castell E. Adherence to an overweight and obesity treatment: how to motivate a patient? PeerJ. 2014 Jul 29;2:e495. doi: 10.7717/peerj.495. eCollection 2014.
Results Reference
result
PubMed Identifier
16608613
Citation
Carey DG, Pliego GJ, Raymond RL, Skau KB. Body composition and metabolic changes following bariatric surgery: effects on fat mass, lean mass and basal metabolic rate. Obes Surg. 2006 Apr;16(4):469-77. doi: 10.1381/096089206776327378.
Results Reference
result
PubMed Identifier
17217636
Citation
Carey DG, Pliego GJ, Raymond RL. Body composition and metabolic changes following bariatric surgery: effects on fat mass, lean mass and basal metabolic rate: six months to one-year follow-up. Obes Surg. 2006 Dec;16(12):1602-8. doi: 10.1381/096089206779319347.
Results Reference
result
PubMed Identifier
25617544
Citation
Kuzmar I, Cortes E, Rizo M. Age group, menarche and regularity of menstrual cycles as efficiency predictors in the treatment of overweight. Nutr Hosp. 2014 Oct 30;31(2):637-41. doi: 10.3305/nh.2015.31.2.7501.
Results Reference
result
PubMed Identifier
17116424
Citation
Strain GW, Gagner M, Inabnet WB, Dakin G, Pomp A. Comparison of effects of gastric bypass and biliopancreatic diversion with duodenal switch on weight loss and body composition 1-2 years after surgery. Surg Obes Relat Dis. 2007 Jan-Feb;3(1):31-6. doi: 10.1016/j.soard.2006.09.002. Epub 2006 Nov 20.
Results Reference
result

Learn more about this trial

Medical Supervised Duodenal-Enteral Feeding Treatment

We'll reach out to this number within 24 hrs