Severe ObesityNEPNCT01965990
VLCD by Enteral Route for Weight Loss
An observational study of Severe Obesity, run by San Giuseppe Moscati Hospital at 1 site in Italy.
Trial summary
Body weight excess, from overweight to overt obesity, is associated with adverse health outcomes. In view of the time-trends of the obesity epidemic and the related cost burden, the search for effective strategies for weight reduction and long-term maintenance of weight loss (WL) is at the top of the agenda of public… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Severe Obesity
- What is being tested?
- NEP
- Type of treatment
- Pill or oral medicine
- How many people
- 364 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2010to Feb 2013
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive severly obese patients attending the Clinical Nutrition Unit of our institution for a weight loss program
Who may be able to join
- age >=18 years
- severe obesity (body mass index [BMI] >=40 kg/m2)
- history of multiple failures in weight loss programs
Who cannot join
- age >=70 years
- insulin-dependent diabetes mellitus
- a psychiatric disorder
- previous (<1 year since last chemo- or radiotherapy) neoplastic disease
- current neoplastic disease
- established vascular disease
Show all 17Show fewer
- recent (6 months), history of diet-induced or unintentional weight loss
- moderate-to-severe heart failure
- arrhythmia
- renal failure (creatinine >1.5 mg/dL)
- current hepatitis
- liver cirrhosis
- any type of gastrointestinal disease
- moderate-severe hypoalbuminemia (<3.0 g/dL)
- altered serum electrolytes
- any other contra-indication to enteral nutrition
- refusal to give written informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site
Clinical Nutrition Unit - A.O.R.N. "San Giuseppe Moscati"
Avellino, Avellino, 83100
About this study
Official title: A 2-week Course of Enteral Treatment With a Very Low-calorie Protein-based Formula for the Management of Severe Obesity
Body weight excess, from overweight to overt obesity, is associated with adverse health outcomes. In view of the time-trends of the obesity epidemic and the related cost burden, the search for effective strategies for weight reduction and long-term maintenance of weight loss (WL) is at the top of the agenda of public health systems.
The current first-line strategy includes several treatment options and dietary interventions to be implemented together with an exercise program. Unfortunately, compliance with intervention in the long-term is difficult. It is not infrequent to observe people following one diet after another and experiencing multiple failures which, in turn, lead to higher body weight and adverse consequences on body composition and fat distribution. The higher the number of attempts, the more difficult the adherence to further interventions. In the presence of severe (body mass index >40 kg/m2) or complicated obesity, bariatric surgery could be proposed. This therapeutic option is effective, but is not devoid of complications and may be irreversible. Obesity-related complications, such as diabetes, hypertension or sleep apnoea are likely to occur more frequently with increasing body mass index (BMI) and rapid and considerable WL is mandatory to curtail such risks.
Read more
In this scenario, alternative treatment options are warranted. About 40 years ago, after the introduction of protein-sparing modified fasting (PSMF) achieved through the use of oral high-protein foods or liquid formula diets by Blackburn and Bistrian, several studies evaluated its effectiveness and safety. They showed that responsible and supervised very-low calorie diets (VLCDs) could be considered safe and appropriate therapy for obesity.
The purpose of the present study was to investigate the potential role of a 2-week course of enteral treatment with a very low-calorie protein-based formula in the management of severe obesity.
The rationale of this treatment option rests on the following considerations: 1) VLCDs appear to be able to reduce cardiovascular risk rapidly and effectively; 2) VLCDs induce considerable short and long-term WL; 3) optimal compliance with the intervention, as active participation of the patient is not required; 4) continuous administration of the intervention formula by enteral route enables the the maintenance of the body amino acid pool.
Before being proposed for clinical use, a new WL program should be scientifically evaluated. Accordingly, in the present study, attention was focused not only on efficacy in terms of improving the cardiometabolic risk profile, but also on the feasibility and safety of the procedure.
- Conditions
- Severe Obesity
- Being tested
- NEP
- Keywords
- Enteral nutrition, very low-calorie diet, severe obesity, weight loss, ketosis
- Medical subject headings
- Obesity, Morbid, Weight Loss, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEPOther
A homemade very low-calorie protein-based formula by enteral route (8-French nasogastric tube) for 14 days. The administration was continuous (h-24) by a feeding pump. The formula was made up of a fixed amount of aminoacids and a variable amount of high-quality proteins: 1.2 g/kg (ideal body weight). Other components were: pro-lipolytic substances (coenzyme Q10 and L-carnitine), linseed oil, policosanol, fructo-oligo saccharides, potassium, sodium and magnesium chloride. The intervention included also the daily oral administration of a multivitamin-multimineral supplement, alkalizing substances (calcium carbonate, 1500 mg; magnesium carbonate, 850 mg; potassium bicarbonate, 500 mg; sodium bicarbonate, 1500 mg; potassium citrate, 500 mg) and herbal remedies. All patients were also prescribed treatment with a proton pump inhibitor and ursodeoxycholic acid. A minimum intake of 2 liters/day of unsweetened fluids was recommended (3 litres in case of a history of kidney stones).
| Study group | Role | What they receive |
|---|---|---|
| NEP | Patients undergoing the administration of a homemade very low-calorie protein-based formula (2000 mL per day) by enteral route for 14 days Receives: Other: NEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Percentage of weight loss
Measured: 14 days
Feasibility
Necessity to discontinue the intervention
Measured: 14 days
Safety
Frequency of the following side effects: asthenia, headache, dizziness, fainting, orthostatic hypotension, heartburn, nausea, vomiting, palpitations, muscle cramps, hunger, constipation. evaluation of changes in the following hematological and biochemical parameters and, for those presenting with normal values, by the excursion outside of the reference ranges of our laboratory (new cases): hemoglobin, total lymphocyte count, urea, creatinine, uric acid, albumin, serum enzymes (cholinesterase, transaminases, γ-glutamyl-transferase, serum creatine phosphokinase and serum lactate dehydrogenase ) and electrolytes (sodium, potassium, magnesium, calcium and phosphorus).
Measured: 14 days
Secondary outcomes (1)
Anthropometric and biochemical parameters
Changes (increase [high density cholesterol, apolipoprotein A-I and growth hormone] or more frequently reduction [all the others]) in the following study parameters: body mass index, waist circumference, hip circumference, waist-hip ratio, uric acid, glucose, insulin, insulin resistance, C-peptide, glycosylated hemoglobin, insulin-like growth factor 1, total cholesterol, high density cholesterol, low density cholesterol, triglycerides, triglyceride/high density cholesterol ratio, apolipoprotein B, apolipoprotein B/apolipoprotein A-I ratio, transaminases, γ-glutamyl-transferase.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2013 (estimated)
- Study startApr 2010
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Giuseppe Moscati Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Castaldo, San Giuseppe Moscati Hospital
- Investigators
- Giuseppe Castaldo, MD, Principal investigator, Clinical Nutrition Unit - A.O.R.N. "San Giuseppe Moscati", Avellino, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01965990
- Sponsor's protocol ID
- 23bis
- Acronym
- NEP
- Status last verified
- Oct 2013
- First submitted
- 16 Oct 2013
- Last updated
- 22 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Castaldo G, Monaco L, Castaldo L, Sorrentino P. A 2-Week Course of Enteral Treatment with a Very Low-Calorie Protein-Based Formula for the Management of Severe Obesity. Int J Endocrinol. 2015;2015:723735. doi: 10.1155/2015/723735. Epub 2015 May 6.
PubMed 26064113
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-week Course of Enteral Treatment With a Very Low-calorie Protein-based Formula for the Management of Severe Obesity
- ClinicalTrials.gov ID
- NCT01965990
- Acronym / sponsor ID
- NEP / 23bis
- Conditions
- Severe Obesity
- Keywords
- Enteral nutrition, very low-calorie diet, severe obesity, weight loss, ketosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- San Giuseppe Moscati HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 18 Oct 2013 (estimated)
- 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.
Body weight excess, from overweight to overt obesity, is associated with adverse health outcomes. In view of the time-trends of the obesity epidemic and the related cost burden, the search for effective strategies for weight reduction and long-term maintenance of weight loss (WL) is at the top of the agenda of public health systems.
The current first-line strategy includes several treatment options and dietary interventions to be implemented together with an exercise program. Unfortunately, compliance with intervention in the long-term is difficult. It is not infrequent to observe people following one diet after another and experiencing multiple failures which, in turn, lead to higher body weight and adverse consequences on body composition and fat distribution. The higher the number of attempts, the more difficult the adherence to further interventions. In the presence of severe (body mass index >40 kg/m2) or complicated obesity, bariatric surgery could be proposed. This therapeutic option is effective, but is not devoid of complications and may be irreversible. Obesity-related complications, such as diabetes, hypertension or sleep apnoea are likely to occur more frequently with increasing body mass index (BMI) and rapid and considerable WL is mandatory to curtail such risks.
In this scenario, alternative treatment options are warranted. About 40 years ago, after the introduction of protein-sparing modified fasting (PSMF) achieved through the use of oral high-protein foods or liquid formula diets by Blackburn and Bistrian, several studies evaluated its effectiveness and safety. They showed that responsible and supervised very-low calorie diets (VLCDs) could be considered safe and appropriate therapy for obesity.
The purpose of the present study was to investigate the potential role of a 2-week course of enteral treatment with a very low-calorie protein-based formula in the management of severe obesity.
The rationale of this treatment option rests on the following considerations: 1) VLCDs appear to be able to reduce cardiovascular risk rapidly and effectively; 2) VLCDs induce considerable short and long-term WL; 3) optimal compliance with the intervention, as active participation of the patient is not required; 4) continuous administration of the intervention formula by enteral route enables the the maintenance of the body amino acid pool.
Before being proposed for clinical use, a new WL program should be scientifically evaluated. Accordingly, in the present study, attention was focused not only on efficacy in terms of improving the cardiometabolic risk profile, but also on the feasibility and safety of the procedure.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NEP | – | Other: NEPPatients undergoing the administration of a homemade very low-calorie protein-based formula (2000 mL per day) by enteral route for 14 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive severly obese patients attending the Clinical Nutrition Unit of our institution for a weight loss program
Key inclusion criteria (3 listed)
- age >=18 years
- severe obesity (body mass index [BMI] >=40 kg/m2)
- history of multiple failures in weight loss programs
Key exclusion criteria (17 listed)
- age >=70 years
- insulin-dependent diabetes mellitus
- a psychiatric disorder
- previous (<1 year since last chemo- or radiotherapy) neoplastic disease
- current neoplastic 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 |
|---|---|---|
| NEPA homemade very low-calorie protein-based formula by enteral route (8-French nasogastric tube) for 14 days. The administration was continuous (h-24) by a feeding pump. The formula was made up of a fixed amount of aminoacids and a variable amount of high-quality proteins: 1.2 g/kg (ideal body weight). Other components were: pro-lipolytic substances (coenzyme Q10 and L-carnitine), linseed oil, policosanol, fructo-oligo saccharides, potassium, sodium and magnesium chloride. The intervention included also the daily oral administration of a multivitamin-multimineral supplement, alkalizing substances (calcium carbonate, 1500 mg; magnesium carbonate, 850 mg; potassium bicarbonate, 500 mg; sodium bicarbonate, 1500 mg; potassium citrate, 500 mg) and herbal remedies. All patients were also prescribed treatment with a proton pump inhibitor and ursodeoxycholic acid. A minimum intake of 2 liters/day of unsweetened fluids was recommended (3 litres in case of a history of kidney stones). | Other | NEP |
Primary outcome
Weight loss
Time frame: 14 days
Percentage of weight loss
Feasibility
Time frame: 14 days
Necessity to discontinue the intervention
Safety
Time frame: 14 days
Frequency of the following side effects: asthenia, headache, dizziness, fainting, orthostatic hypotension, heartburn, nausea, vomiting, palpitations, muscle cramps, hunger, constipation. evaluation of changes in the following hematological and biochemical parameters and, for those presenting with normal values, by the excursion outside of the reference ranges of our laboratory (new cases): hemoglobin, total lymphocyte count, urea, creatinine, uric acid, albumin, serum enzymes (cholinesterase, transaminases, γ-glutamyl-transferase, serum creatine phosphokinase and serum lactate dehydrogenase ) and electrolytes (sodium, potassium, magnesium, calcium and phosphorus).
1 secondary outcome
Anthropometric and biochemical parameters
Time frame: 14 days
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 22 Oct 2013.
- Derived from this study: PubMed 26064113Castaldo G, Monaco L, Castaldo L, Sorrentino P. A 2-Week Course of Enteral Treatment with a Very Low-Calorie Protein-Based Formula for the Management of Severe Obesity. Int J Endocrinol. 2015;2015:723735. doi: 10.1155/2015/723735. Epub 2015 May 6.
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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.
Giuseppe Castaldo, MD principal investigator
Clinical Nutrition Unit - A.O.R.N. "San Giuseppe Moscati", Avellino, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Obesity, run by San Giuseppe Moscati Hospital at 1 site in Italy.
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 3 inclusion and 17 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 22 Oct 2013. 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 Italy. 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?
Weight loss (time frame: 14 days). The study lists 3 primary outcomes in all. 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 NCT01965990, which also lists 1 linked publication.
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 22 Oct 2013.