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Randomized Trial of Preoperative Diets Before Bariatric Surgery

Comparison of Preoperative Diets Before Bariatric Surgery: a Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01652105
Enrollment
100
Registered
2012-07-27
Start date
2012-09-30
Completion date
2013-06-30
Last updated
2012-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery, Gastric Bypass, Morbid Obesity

Keywords

Gastric bypass, Preoperative diet, Prodimed

Brief summary

Randomized clinical trial of two preoperative diets before bariatric surgery (gastric bypass)comparing standard diet and Prodimed (VLCD) in 100 morbidly obese patients selected for a gastric bypass procedure

Detailed description

Morbid obesity, defined as a body mass index (BMI) of \> 40 kg/m² or \> 35 kg/m² with obesity-related comorbidities, is a rapidly growing problem in the western society. In the United States, about 6 million people currently have a BMI of \> 40 kg/m² and another 10 million people have a BMI of \> 35 kg/m² with comorbidities. Worldwide, the incidence of morbid obesity has doubled and about 300 million people are now obese. In the Netherlands the prevalence is less disturbing but the incidence of morbid obesity is rising progressively to 1.5% of the total population. At this moment surgical therapy is the only treatment option for these patients that results in sufficient long-term weight loss. Non-surgical approaches, like low energy diets and behavior modification, are not successful in the long-term with respect to maintaining weight loss and decreasing obesity-related comorbidities. In order to increase weight loss and minimize complications a preoperative diet before bariatric has been advocated. However, the usual VLCD's are poorly tolerated by patients. In this study we aim to compare two preoperative diets in order to find the most suitable for this patient population.

Interventions

DIETARY_SUPPLEMENTStandard diet versus standard VLCD (Prodimed)

Sponsors

Lievensberg Ziekenhuis
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* morbid obesity according to IFSO criteria

Exclusion criteria

* previous bariatric or gastric surgery * severe psychiatric disorders

Design outcomes

Primary

MeasureTime frameDescription
Preoperative weight loss before bariatric surgery2 weeksWeight loss in kg before operation

Secondary

MeasureTime frameDescription
- operation time - blood loss - difficulty of procedure - short term complications - acceptance of diets according to patients2 weeksMeasured by VAS, diet books and questionnaires

Countries

Netherlands

Contacts

Primary ContactRuben Schouten, Md, PhD
schoutenruben@hotmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026