Medical Supervised Duodenal-Enteral Feeding Treatment

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03542864
• Other study ID #: BCE26418
• Status: Completed
• Phase: N/A
• Start date: August 3, 2017
• Est. completion date: January 4, 2019

Study information

• Verified date: July 2019
• Source: BiomediKcal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 4, 2019
• Est. primary completion date: December 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Fat Disorder
• Disease
• Endocrine System Diseases
• Feeding and Eating Disorders
• Hormone Disturbance
• Lipid Metabolism Disorders
• Obesity
• Obesity, Abdominal
• Obesity, Visceral
• Overweight
• Overweight and Obesity
• Weight Loss

Intervention

Dietary Supplement:
• Nasogastroduodenal Protocol
Complete nutrition (carbohydrates, lipids, proteins, vitamins, oligoelements)

Other:
• Control
Progress registration of body composition values
• Data analysis
Statistical analysis of all data

Locations

Country	Name	City	State
Colombia	BiomediKcal - Advanced Medical Nutrition & Lifestyle Center	Barranquilla	Atlantico

Sponsors (3)

Lead Sponsor	Collaborator
BiomediKcal	Universidad Miguel Hernandez de Elche, University of Alicante

Country where clinical trial is conducted

Colombia, 

References & Publications (5)

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. — View Citation

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. — View Citation

Kuzmar I, Cortés 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. — View Citation

Kuzmar I, Rizo M, Cortés-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. — View Citation

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. Epub 200 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weightloss	Decrease, minor difference in weight at the end of treatment	Change from Baseline weight at 1 and 3 months
Secondary	Fat loss	Decrease, minor difference in percentage of fat at the end of treatment	Change from Baseline fat percentage at 1 and 3 months
Secondary	Loss of measures	Decrease of measurements in perimeters (arm, waist, hip, thigh)	Change from Baseline measures at 1 and 3 months