A Phase II Study of the Effect of a Low Calorie Diet on Patients Undergoing Liver Resection

Dartmouth Health

Status: Completed

Conditions: Steatohepatitis; Nonalcoholic Fatty Liver Disease; Hepatic Steatosis

Treatments: Dietary Supplement: Optifast 800

Study type: Interventional

Funder types: Other

Identifiers

NCT01645852

DMS 12052

Details and patient eligibility

About

The purpose of this study is to measure the effect of a short-term low calorie diet on patients with a Body Mass Index (BMI) over 25 who are undergoing liver surgery.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 or greater
• Clinical indication for a therapeutic liver resection
• BMI of 25 kg/m2 or greater
• Informed Consent

Exclusion criteria

• Inability to comply with the pre-op diet
• Patients who have lost 5% or more of their usual body weight over the preceding one month
• Female patients of childbearing age who have a positive pregnancy test

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

65 participants in 2 patient groups

Control

No Intervention group

Description:

No specified diet for one week prior to hepatic resection.

Low calorie diet

Active Comparator group

Description:

Low calorie diet (five units of Optifast 800 {Nestle Nutrition, Vevey, Switzerland} plus an unlimited volume of calorie free fluids per day) for one week prior to hepatic resection.

Treatment:

Dietary Supplement: Optifast 800