Effects of two preoperatory weight loss diets on hepatic volume and surgical complications in morbid obese bariatric surgery candidates
| ISRCTN | ISRCTN16967604 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16967604 |
| Secondary identifying numbers | 14-09-18/9proj4 |
- Submission date
- 19/02/2018
- Registration date
- 23/02/2018
- Last edited
- 30/08/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
The aim of this study is to assess which type of dietary strategy is the most effective for patients with morbid obesity who are about to undergo weight loss (bariatric) surgery. It is thought that a low calorie diet will be more effective than a very low calorie diet (e.g. it will reduce surgical complications and length of hospital stay).
Who can participate?
Patients with morbid obesity undergoing bariatric surgery
What does the study involve?
Participants are randomly allocated to follow a very low calorie diet or a low calorie diet for 21 days before surgery. Body measurements, blood parameters, liver volume by CT scan, and compliance with the intervention are measured before and after the intervention.
What are the possible benefits and risks of participating?
In the short term, it is not expected that the results obtained may directly benefit the participant, although they could be of interest for future patients undergoing bariatric surgery. The study does not pose any additional risk apart from providing blood samples and undergoing CT scans.
Where is the study run from?
Hospital Universitari Sant Joan de Reus (Spain)
When is the study starting and how long is it expected to run for?
September 2014 to July 2017
Who is funding the study?
Nestle S.A.
Who is the main contact?
Dr Jordi Salas Salvado
Contact information
Scientific
Human Nutrition Unit, Faculty of Medicine and Health Sciences
Universitat Rovira i Virgili
C/Sant Llorenç 21
Reus
43201
Spain
Study information
| Study design | Single-center randomized parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Effects of two preoperatory weight loss diets on hepatic volume and surgical complications in morbid obese bariatric surgery candidates: a randomized clinical trial |
| Study objectives | Pre-operative weight loss in patients with morbid obesity candidates for bariatric surgery through the use of a Low Calorie Diet (LCD) will be more effective than a Very Low Calorie Diet (VLCD) on the preservation of protein and immune status, reduction of surgical complications, hospital stay and will be equally effective in terms of reduction in liver volume. |
| Ethics approval(s) | Ethical committee of the University Hospital Sant Joan de Reus, 29/01/2015, CEIC reference project: 14-09-18 / 9proj4, reference CEIC esmena: 15-01-29 / 1esmproj1 |
| Health condition(s) or problem(s) studied | Influence of two types of pre-surgery diets on the decrease of hepatomegaly in morbidly obese candidates for bariatric surgery |
| Intervention | Subjects will be randomized with a 1:1 ratio using an excel randomization table to follow a very low calorie diet (VLCD) or a low-calorie diet (LCD) for a period of 21 days. Both dietary interventions had the same percentage of macronutrients (46.8% carbohydrates, 36.4% protein, 9.3% fat, and 7.4% fiber). The total amount of energy administered with the VLCD (4 sachets of Optifast®; Nestlé Health Science; 2011) will be 800 kcal/day, broth and non-calorie beverages allowed. The LCD diet consisted of a defined fixed diet containing 1200 kcal/day also using two sachets of Optifast®. |
| Intervention type | Mixed |
| Primary outcome measure | Hepatic volume through computed tomography at baseline and 21 days after dietary intervention |
| Secondary outcome measures | 1. Body weight and anthropometry parameters at baseline and at 21 days of intervention 2. Leukocyte count and serum albumin, prealbumin and total proteins at baseline and at 21 days of intervention 3. Renal and hepatic function parameters at baseline and at 21 days of intervention 4. Surgery complications (between surgery until 6 months after surgery) and hospital stay length (during the hospital stay) 5. Dietary compliance and acceptability, assessed weekly during the first 3 weeks of the intervention |
| Overall study start date | 01/09/2014 |
| Completion date | 31/07/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 80 effectively randomized participants: 40 in each group |
| Key inclusion criteria | BMI ≥ 40 kg/m2 or BMI between 35-40 kg/m2 with associated major comorbidities undergoing bariatric surgery |
| Key exclusion criteria | The same criteria established by hospital protocol for patients undergoing bariatric surgery |
| Date of first enrolment | 01/03/2015 |
| Date of final enrolment | 31/07/2017 |
Locations
Countries of recruitment
- Spain
Study participating centre
Reus (Tarragona)
43204
Spain
Sponsor information
Hospital/treatment centre
Avinguda Dr Josep Laporte, 2
Reus (Tarragona)
43204
Spain
"ROR" |
https://ror.org/04f7pyb58 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/07/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The protocol and statistical plan are not available. Planned publication of the results in a high-impact peer reviewed journal. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 29/08/2018 | 30/08/2018 | No | No | |
| Results article | results | 01/12/2018 | Yes | No |
Additional files
- ISRCTN16967604_BasicResults_29Aug18.pdf
- Uploaded 30/08/2018
Editorial Notes
30/08/2018: The basic results of this trial have been uploaded as an additional file.
28/08/2018: Publication reference added.
