Clinical trial NCT03542864: Medical Supervised Duodenal-Enteral Feeding Treatment
Official title: Medical Supervised Duodenal-Enteral Feeding for Overweight, Obesity and Increased Body Fat Percentage Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Obesity, Visceral
Overweight and Obesity
Body Fat Disorder
Feeding and Eating Disorders
Hormone Disturbance
Weight Loss
Keywords: obesity
overweight
fat percentage
body fat
enteral feeding
fat loss
Lead sponsor: BiomediKcal
Sponsor class: OTHER
Collaborators: name: University of Alicante
name: Universidad Miguel Hernandez de Elche
First posted: 2018-05-31
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Duodenal-Enteral medical supervised feeding response
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Weightloss
timeFrame: Change from Baseline weight at 1 and 3 months
Secondary outcomes:
measure: Fat loss
timeFrame: Change from Baseline fat percentage at 1 and 3 months
measure: Loss of measures
timeFrame: Change from Baseline measures at 1 and 3 months
Other outcomes:
Locations:
city: Barranquilla
country: Colombia
facility: BiomediKcal - Advanced Medical Nutrition & Lifestyle Center
state: Atlantico
Study officials:
affiliation: BiomediKcal - Advanced Medical Nutrition & Lifestyle Center
name: Isaac Kuzmar, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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. doi: 10.1381/096089206779319347.
citation: 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.
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. doi: 10.1016/j.soard.2006.09.002. Epub 2006 Nov 20.