Medical Supervised Duodenal-Enteral Feeding Treatment

Study Overview
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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.

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

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

Intervention / Treatment
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* Dietary Supplement: Nasogastroduodenal Protocol
* Other: Control
* Other: Data analysis


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Duodenal-Enteral medical supervised feeding response
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nasogastroduodenal Protocol<br>Evaluation of a protocol for the treatment of excess body fat through duodenal nutrition | Dietary Supplement: Nasogastroduodenal Protocol<br>* Complete nutrition (carbohydrates, lipids, proteins, vitamins, oligoelements)<br>* Other names: Medical-Clinical-Nutrition assessment;|
| Active Comparator: Controls<br>Change from Baseline Body Composition values at 1 and 3 months | Other: Control<br>* Progress registration of body composition values<br>* Other names: Progress;|
| Other: Data analysis<br>Analysis and publication of data | Other: Data analysis<br>* Statistical analysis of all data<br>* Other names: Statistics;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weightloss | 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 | 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 | Decrease of measurements in perimeters (arm, waist, hip, thigh) | Change from Baseline measures at 1 and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, overweight, fat percentage, body fat, enteral feeding, fat loss