ObesityNCT03542864
Medical Supervised Duodenal-Enteral Feeding Treatment
A study testing Nasogastroduodenal Protocol and Data analysis in people with Obesity and Obesity, Visceral, run by BiomediKcal at 1 site in Colombia.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Obesity, Visceral, Overweight and Obesity
- What is being tested?
- Nasogastroduodenal Protocol and Data analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteColombia
- Study dates
- 3 Aug 2017to 4 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Desire for weight loss, desire to improve body image, voluntariness
Who cannot join
- esophageal alteration or swallowing, not sign the informed consent, acute active disease
Trial locations and contacts
1 site in 1 country.
Colombia1 site
BiomediKcal - Advanced Medical Nutrition & Lifestyle Center
Barranquilla, Atlántico, 080020
About this study
Official title: Medical Supervised Duodenal-Enteral Feeding for Overweight, Obesity and Increased Body Fat Percentage 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.
Read the 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.
- Conditions
- Obesity, Obesity, Visceral, Overweight and Obesity, Body Fat Disorder, Feeding and Eating Disorders, Hormone Disturbance
- Being tested
- Nasogastroduodenal Protocol, Control, Data analysis
- Keywords
- obesity, overweight, fat percentage, body fat, enteral feeding, fat loss
- Medical subject headings
- Obesity, Obesity, Abdominal, Overweight, Feeding and Eating Disorders, Endocrine System Diseases, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasogastroduodenal ProtocolDietary supplement
Also called Medical-Clinical-Nutrition assessment
Complete nutrition (carbohydrates, lipids, proteins, vitamins, oligoelements)
ControlOther
Also called Progress
Progress registration of body composition values
Data analysisOther
Also called Statistics
Statistical analysis of all data
| Study group | Role | What they receive |
|---|---|---|
| Nasogastroduodenal Protocol | Experimental | Evaluation of a protocol for the treatment of excess body fat through duodenal nutrition Receives: Dietary Supplement: Nasogastroduodenal Protocol |
| Controls | Active comparator | Change from Baseline Body Composition values at 1 and 3 months Receives: Other: Control |
| Data analysis | Other | Analysis and publication of data Receives: Other: Data analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weightloss
Decrease, minor difference in weight at the end of treatment
Measured: Change from Baseline weight at 1 and 3 months
Secondary outcomes (2)
Fat loss
Decrease, minor difference in percentage of fat at the end of treatment
Measured: Change from Baseline fat percentage at 1 and 3 months
Loss of measures
Decrease of measurements in perimeters (arm, waist, hip, thigh)
Measured: Change from Baseline measures at 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start3 Aug 2017
- Primary completion23 Dec 2018
- Study completion4 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Duodenal-Enteral medical supervised feeding response
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- BiomediKcal
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alicante, Universidad Miguel Hernandez de Elche
- Responsible party
- Principal investigator, Isaac Kuzmar, MD, MBT, MsCN, PhD, BiomediKcal
- Investigators
- Isaac Kuzmar, Dr, Principal investigator, BiomediKcal - Advanced Medical Nutrition & Lifestyle Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542864
- Sponsor's protocol ID
- BCE26418
- Status last verified
- Jul 2019
- First submitted
- 26 Apr 2018
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only available for scientific journal review process
Publications
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.
PubMed 25101227Carey 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.
PubMed 16608613Carey 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.
PubMed 17217636Kuzmar 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.
PubMed 25617544Strain 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.
PubMed 17116424
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Supervised Duodenal-Enteral Feeding for Overweight, Obesity and Increased Body Fat Percentage Treatment
- ClinicalTrials.gov ID
- NCT03542864
- Acronym / sponsor ID
- BCE26418
- Conditions
- Obesity, Obesity, Visceral, Overweight and Obesity, Body Fat Disorder, Feeding and Eating Disorders, Hormone Disturbance
- Keywords
- obesity, overweight, fat percentage, body fat, enteral feeding, fat loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- BiomediKcalUniversity, hospital or other
- Collaborators
- University of Alicante, Universidad Miguel Hernandez de Elche
- Study start
- 3 Aug 2017 (actual)
- Primary completion
- 23 Dec 2018 (actual)
- Study completion
- 4 Jan 2019 (actual)
- First posted
- 31 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Duodenal-Enteral medical supervised feeding response
| Arm | Type | Receives |
|---|---|---|
| Nasogastroduodenal Protocol | Experimental | Dietary Supplement: Nasogastroduodenal ProtocolEvaluation of a protocol for the treatment of excess body fat through duodenal nutrition |
| Controls | Active comparator | Other: ControlChange from Baseline Body Composition values at 1 and 3 months |
| Data analysis | Other | Other: Data analysisAnalysis and publication of data |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Desire for weight loss, desire to improve body image, voluntariness
Key exclusion criteria (1 listed)
- esophageal alteration or swallowing, not sign the informed consent, acute active disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasogastroduodenal ProtocolAlso: Medical-Clinical-Nutrition assessmentComplete nutrition (carbohydrates, lipids, proteins, vitamins, oligoelements) | Dietary supplement | Nasogastroduodenal Protocol |
| ControlAlso: ProgressProgress registration of body composition values | Other | Controls |
| Data analysisAlso: StatisticsStatistical analysis of all data | Other | Data analysis |
Primary outcome
Weightloss
Time frame: Change from Baseline weight at 1 and 3 months
Decrease, minor difference in weight at the end of treatment
2 secondary outcomes
Fat loss
Time frame: Change from Baseline fat percentage at 1 and 3 months
Loss of measures
Time frame: Change from Baseline measures at 1 and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Results publication: PubMed 25101227Kuzmar 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.
- Results publication: PubMed 16608613Carey 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.
- Results publication: PubMed 17217636Carey 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.
- Results publication: PubMed 25617544Kuzmar 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.
- Results publication: PubMed 17116424Strain 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.
- Individual participant dataSharing planned: No. Only available for scientific journal review process
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isaac Kuzmar, Dr principal investigator
BiomediKcal - Advanced Medical Nutrition & Lifestyle Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasogastroduodenal Protocol and Data analysis in people with Obesity and Obesity, Visceral, run by BiomediKcal at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weightloss (time frame: Change from Baseline weight at 1 and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03542864, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.