Medical Supervised Duodenal-Enteral Feeding Treatment

July 9, 2019 updated by: Isaac Kuzmar, MD, MBT, MsCN, PhD, BiomediKcal

Medical Supervised Duodenal-Enteral Feeding for Overweight, Obesity and Increased Body Fat Percentage Treatment

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Atlantico
      • Barranquilla, Atlantico, Colombia, 080020
        • BiomediKcal - Advanced Medical Nutrition & Lifestyle Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Nasogastroduodenal Protocol
Evaluation of a protocol for the treatment of excess body fat through duodenal nutrition
Dietary supplement: Nasogastroduodenal Protocol
Complete nutrition (carbohydrates, lipids, proteins, vitamins, oligoelements)
Other Names:
  • Medical-Clinical-Nutrition assessment
ACTIVE_COMPARATOR: Controls
Change from Baseline Body Composition values at 1 and 3 months
Other: Control
Progress registration of body composition values
Other Names:
  • Progress
OTHER: Data analysis
Analysis and publication of data
Other: Data analysis
Statistical analysis of all data
Other Names:
  • Statistics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weightloss
Time Frame: Change from Baseline weight at 1 and 3 months
Decrease, minor difference in weight at the end of treatment
Change from Baseline weight at 1 and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fat loss
Time Frame: Change from Baseline fat percentage at 1 and 3 months
Decrease, minor difference in percentage of fat at the end of treatment
Change from Baseline fat percentage at 1 and 3 months
Loss of measures
Time Frame: Change from Baseline measures at 1 and 3 months
Decrease of measurements in perimeters (arm, waist, hip, thigh)
Change from Baseline measures at 1 and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BiomediKcal

Collaborators

Universidad Miguel Hernandez de Elche
University of Alicante

Investigators

  • Principal Investigator: Isaac Kuzmar, Dr, BiomediKcal - Advanced Medical Nutrition & Lifestyle Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 3, 2017

Primary Completion (ACTUAL)

December 23, 2018

Study Completion (ACTUAL)

January 4, 2019

Study Registration Dates

First Submitted

April 26, 2018

First Submitted That Met QC Criteria

May 30, 2018

First Posted (ACTUAL)

May 31, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 10, 2019

Last Update Submitted That Met QC Criteria

July 9, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCE26418

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only available for scientific journal review process

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Nasogastroduodenal Protocol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe