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Completed

NCT Number: NCT03542864

Medical Supervised Duodenal-Enteral Feeding 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.

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Key information

Conditions

Obesity Body Fat Disorder Body Weight Body Weight Changes Endocrine System Diseases Feeding and Eating Disorders Hormone Disturbance Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity, Abdominal Obesity, Visceral Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BiomediKcal - Advanced Medical Nutrition & Lifestyle Center

Barranquilla, Atlántico, 080020, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nasogastroduodenal Protocol

Dietary Supplement

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

Other names: Medical-Clinical-Nutrition assessment

Control

Other

Progress registration of body composition values

Other names: Progress

Data analysis

Other

Statistical analysis of all data

Other names: Statistics

Primary outcomes

  1. Weightloss

    Time frame: Change from Baseline weight at 1 and 3 months

    Decrease, minor difference in weight at the end of treatment

Secondary outcomes

  1. 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

  2. Loss of measures

    Time frame: Change from Baseline measures at 1 and 3 months

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

Sponsors and collaborators

Lead sponsor

BiomediKcal

Other

Collaborators

  • Universidad Miguel Hernandez de Elche
  • University of Alicante

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
May 31, 2018
Registry last updated
Jul 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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