Medical Supervised Duodenal-Enteral Feeding Treatment

NCT ID: NCT03542864

Last Updated: 2019-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-03

Study Completion Date

2019-01-04

Brief Summary

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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

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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.

Conditions

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Obesity Obesity, Visceral Overweight and Obesity Body Fat Disorder Feeding and Eating Disorders Hormone Disturbance Weight Loss

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Duodenal-Enteral medical supervised feeding response
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nasogastroduodenal Protocol

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

Group Type EXPERIMENTAL

Nasogastroduodenal Protocol

Intervention Type DIETARY_SUPPLEMENT

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

Controls

Change from Baseline Body Composition values at 1 and 3 months

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

Progress registration of body composition values

Data analysis

Analysis and publication of data

Group Type OTHER

Data analysis

Intervention Type OTHER

Statistical analysis of all data

Interventions

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Nasogastroduodenal Protocol

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

Intervention Type DIETARY_SUPPLEMENT

Control

Progress registration of body composition values

Intervention Type OTHER

Data analysis

Statistical analysis of all data

Intervention Type OTHER

Other Intervention Names

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Medical-Clinical-Nutrition assessment Progress Statistics

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alicante

OTHER

Sponsor Role collaborator

Universidad Miguel Hernandez de Elche

OTHER

Sponsor Role collaborator

BiomediKcal

OTHER

Sponsor Role lead

Responsible Party

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Isaac Kuzmar, MD, MBT, MsCN, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Isaac Kuzmar, Dr

Role: PRINCIPAL_INVESTIGATOR

BiomediKcal - Advanced Medical Nutrition & Lifestyle Center

Locations

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BiomediKcal - Advanced Medical Nutrition & Lifestyle Center

Barranquilla, Atlántico, Colombia

Site Status

Countries

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Colombia

References

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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.

Reference Type RESULT
PMID: 25101227 (View on PubMed)

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.

Reference Type RESULT
PMID: 16608613 (View on PubMed)

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.

Reference Type RESULT
PMID: 17217636 (View on PubMed)

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.

Reference Type RESULT
PMID: 25617544 (View on PubMed)

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.

Reference Type RESULT
PMID: 17116424 (View on PubMed)

Other Identifiers

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BCE26418

Identifier Type: -

Identifier Source: org_study_id

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