Effects of two preoperatory weight loss diets on hepatic volume and surgical complications in morbid obese bariatric surgery candidates

Effects of two preoperatory weight loss diets on hepatic volume and surgical complications in morbid obese bariatric surgery candidates: a randomized clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16967604

Enrollment

Registered

2018-02-23

Start date

2015-03-01

Completion date

Unknown

Last updated

2018-09-10

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

Conditions

Influence of two types of pre-surgery diets on the decrease of hepatomegaly in morbidly obese candidates for bariatric surgery Surgery

Interventions

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

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®.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: BMI = 40 kg/m2 or BMI between 35-40 kg/m2 with associated major comorbidities undergoing bariatric surgery

Exclusion criteria

Exclusion criteria: The same criteria established by hospital protocol for patients undergoing bariatric surgery

Design outcomes

Primary

Measure	Time frame
Hepatic volume through computed tomography at baseline and 21 days after dietary intervention	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026