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Medical Supervised Duodenal-Enteral Feeding Treatment

Sponsor
BiomediKcal (Other)
Overall Status
Completed
CT.gov ID
NCT03542864
Collaborator
University of Alicante (Other), Universidad Miguel Hernandez de Elche (Other)
31
Enrollment
1
Location
3
Arms
17.1
Actual Duration (Months)
1.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Nasogastroduodenal Protocol
  • Other: Control
  • Other: Data analysis
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Duodenal-Enteral medical supervised feeding responseDuodenal-Enteral medical supervised feeding response
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Medical Supervised Duodenal-Enteral Feeding for Overweight, Obesity and Increased Body Fat Percentage Treatment
Actual Study Start Date :
Aug 3, 2017
Actual Primary Completion Date :
Dec 23, 2018
Actual Study Completion Date :
Jan 4, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Weightloss [Change from Baseline weight at 1 and 3 months]

      Decrease, minor difference in weight at the end of treatment

    Secondary Outcome Measures

    1. Fat loss [Change from Baseline fat percentage at 1 and 3 months]

      Decrease, minor difference in percentage of fat at the end of treatment

    2. Loss of measures [Change from Baseline measures at 1 and 3 months]

      Decrease of measurements in perimeters (arm, waist, hip, thigh)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 BiomediKcal - Advanced Medical Nutrition & Lifestyle Center Barranquilla Atlantico Colombia 080020

    Sponsors and Collaborators

    • BiomediKcal
    • University of Alicante
    • Universidad Miguel Hernandez de Elche

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Isaac Kuzmar, MD, MBT, MsCN, PhD, Principal Investigator, BiomediKcal
    ClinicalTrials.gov Identifier:
    NCT03542864
    Other Study ID Numbers:
    • BCE26418
    First Posted:
    May 31, 2018
    Last Update Posted:
    Jul 10, 2019
    Last Verified:
    Jul 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Isaac Kuzmar, MD, MBT, MsCN, PhD, Principal Investigator, BiomediKcal
    obesity
    overweight
    fat percentage
    body fat
    enteral feeding
    fat loss
    Additional relevant MeSH terms:
    Obesity
    Obesity, Abdominal
    Endocrine System Diseases
    Disease
    Overweight
    Weight Loss
    Feeding and Eating Disorders

    Study Results

    No Results Posted as of Jul 10, 2019