NCT03542864

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Aug 2017

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

August 3, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 31, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2018

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2019

Completed
Last Updated

July 10, 2019

Status Verified

July 1, 2019

Enrollment Period

1.4 years

First QC Date

April 26, 2018

Last Update Submit

July 9, 2019

Conditions

ObesityObesity, VisceralOverweight and ObesityBody Fat DisorderFeeding and Eating DisordersHormone DisturbanceWeight Loss

Keywords

obesityoverweightfat percentagebody fatenteral feedingfat loss

Outcome Measures

Primary Outcomes (1)

  • Weightloss

    Decrease, minor difference in weight at the end of treatment

    Change from Baseline weight at 1 and 3 months

Secondary Outcomes (2)

  • Fat loss

    Change from Baseline fat percentage at 1 and 3 months

  • Loss of measures

    Change from Baseline measures at 1 and 3 months

Study Arms (3)

Nasogastroduodenal Protocol

EXPERIMENTAL

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

Dietary Supplement: Nasogastroduodenal Protocol

Controls

ACTIVE COMPARATOR

Change from Baseline Body Composition values at 1 and 3 months

Other: Control

Data analysis

OTHER

Analysis and publication of data

Other: Data analysis

Interventions

Nasogastroduodenal ProtocolDIETARY_SUPPLEMENT

Complete nutrition (carbohydrates, lipids, proteins, vitamins, oligoelements)

Also known as: Medical-Clinical-Nutrition assessment
Nasogastroduodenal Protocol
ControlOTHER

Progress registration of body composition values

Also known as: Progress
Controls
Data analysisOTHER

Statistical analysis of all data

Also known as: Statistics
Data analysis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BiomediKcal - Advanced Medical Nutrition & Lifestyle Center

Barranquilla, Atlántico, 080020, Colombia

Location

Related Publications (5)

  • 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.

    PMID: 25101227RESULT

  • 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.

    PMID: 16608613RESULT

  • 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.

    PMID: 17217636RESULT

  • 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.

    PMID: 25617544RESULT

  • 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.

    PMID: 17116424RESULT

MeSH Terms

Conditions

ObesityObesity, AbdominalOverweightFeeding and Eating DisordersEndocrine System DiseasesWeight Loss

Interventions

Helio Progress

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveMental DisordersBody Weight Changes

Study Officials

  • Isaac Kuzmar, Dr

    BiomediKcal - Advanced Medical Nutrition & Lifestyle Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Duodenal-Enteral medical supervised feeding response
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 26, 2018

First Posted

May 31, 2018

Study Start

August 3, 2017

Primary Completion

December 23, 2018

Study Completion

January 4, 2019

Last Updated

July 10, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Only available for scientific journal review process

Locations

CO(1)