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Low-calorie Diet and Body Composition Prior to Roux-en-Y Gastric Bypass (LCD)

Primary Purpose

Morbid Obesity, Liver Fat

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Liquid formula low-calorie diet (LCD)
Roux-en-Y gastric bypass (RYGB)
Control diet
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Morbid Obesity focused on measuring morbid obesity, gastric bypass, bariatrics, diet, caloric restriction, liver fat, appetite

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients undergoing Roux-en-Y gastric bypass at Imperial Weight Centre
  • aged 18 to 60 years
  • boby mass index of 35 to 55 kg/m2

Exclusion Criteria:

  • Claustrophobia
  • Pacemaker, metal implant, clips, implanted device, shrapnel or bullets, metal in eyes that precludes magnetic resonance imaging
  • Current pregnancy or breast feeding for females (as determined by a pregnancy test)
  • A full term pregnancy within the last year for females
  • Treatment with any medication that might affect the study outcomes
  • Haemorrhagic disorders and anticoagulant treatment
  • History of cancer, excluding skin cancer
  • History of severe or multiple allergies, severe adverse drug reaction or leucopenia
  • Smokers
  • Regular drinkers of more than three units of alcohol daily
  • History of, or current evidence of, abuse of alcohol or any drug substance, licit or illicit
  • Regular intake of over-the-counter (OTC) medication (other than the occasional paracetamol/aspirin)
  • Poor compliers or subjects unlikely to commit to the 26 week study duration
  • Blood donation within the 12 week period before the initial study dose
  • Use of monoamine oxidase inhibitors (MAOIs) as anti depressant

Sites / Locations

  • Imperial Clinical research facility

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Other

Arm Label

2-week LCD and Roux-en-Y gastric bypass (RYGB)

6-week LCD

Control diet

Arm Description

A 2-week liquid formula low-calorie diet (LCD) will be administered for 2 weeks prior to Roux-en-Y gastric bypass. The diet will provide 800kcal per day in the form of powdered milkshakes and soups

A 6-week liquid formula low-calorie diet (LCD) will be administered for 6 weeks prior to Roux-en-Y gastric bypass. The diet will provide 800kcal per day in the form of powdered milkshakes and soups

1000 calorie diet

Outcomes

Primary Outcome Measures

Change in Intra-hepatocellular Lipid Content (IHCL) Following the Pre-operative Diet
Intra-hepatocellular lipid content will be measured by magnetic resonance spectroscopy

Secondary Outcome Measures

Change in Intra-hepatocellular Lipid Content (IHCL) Following Roux-en-Y Gastric Bypass
Intra-hepatocellular lipid content (IHCL) will be compared between groups at 1 month following Roux-en-Y gastric bypass
Change in Intra-hepatocellular Lipid Content (IHCL) Following Roux-en-Y Gastric Bypass
Intra-hepatocellular lipid content (IHCL) will be compared between groups at 6 months following Roux-en-Y gastric bypass
Complexity of Surgery
Complexity of surgery will be assessed by the surgeon at the time of surgery (either after 2 weeks for the Control group and 2-week LCD group or after 6 weeks for the 6-week LCD group) The complexity of the surgery was assessed through a score on a complexity scale based on questionnaires previously published by Anders Thorell"s and David Edholm"s groups (Edholm et al., 2011, Van Nieuwenhove et al., 2011). The scores (1-5) for 7 variables: exposure, bleeding, difficulty in dissection, difficulty in reconstruction, surgical judgment, technical demand and psychological stress were combined into a complexity of surgery score with a minimum of 7 (very little complexity) and a maximum of 35 (very high complexity).
Operative Time
The operative time will be recorded at the time of surgery by the operating surgeon (either after 2 weeks for the Control group and 2-week LCD group or after 6 weeks for the 6-week LCD group)

Full Information

First Posted
May 9, 2014
Last Updated
February 24, 2021
Sponsor
Imperial College London
Collaborators
Cambridge Weight Plan Limited
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1. Study Identification

Unique Protocol Identification Number
NCT02144597
Brief Title
Low-calorie Diet and Body Composition Prior to Roux-en-Y Gastric Bypass
Acronym
LCD
Official Title
The Effect of a 2-week vs. 6-week Low-calorie Diet (LCD) Followed by Roux-en-Y Gastric Bypass (RYGB) on Body Composition and Surgery Outcomes in Obese Humans: a Dietary Intervention and Magnetic Resonance Imaging Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
August 2011 (Actual)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
Cambridge Weight Plan Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Losing weight before undergoing Roux-en-Y gastric bypass (RYGB) surgery may reduce liver fat content and size thereby improving surgical outcomes. This study aims to investigate whether a 2-week or 6-week pre-operative liquid formula low-calorie diet (LCD) reduces liver fat further than a conventional food diet prior to RYGB using magnetic resonance imaging (MRI). The hypothesis is that the 2-week and 6-week liquid formula LCD will reduce liver fat further than the conventional food pre-operative diet.
Detailed Description
The morbidly obese subjects (BMI higher then 40 kg/m2) were randomised and assessed at baseline (week 0). After 2 weeks on a low-calorie diet (LCD), participants underwent either Roux-en-Y gastric bypass (RYGB) or continued with a LCD for 4 weeks.The participants will reassess at week 6.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Liver Fat
Keywords
morbid obesity, gastric bypass, bariatrics, diet, caloric restriction, liver fat, appetite

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2-week LCD and Roux-en-Y gastric bypass (RYGB)
Arm Type
Active Comparator
Arm Description
A 2-week liquid formula low-calorie diet (LCD) will be administered for 2 weeks prior to Roux-en-Y gastric bypass. The diet will provide 800kcal per day in the form of powdered milkshakes and soups
Arm Title
6-week LCD
Arm Type
Active Comparator
Arm Description
A 6-week liquid formula low-calorie diet (LCD) will be administered for 6 weeks prior to Roux-en-Y gastric bypass. The diet will provide 800kcal per day in the form of powdered milkshakes and soups
Arm Title
Control diet
Arm Type
Other
Arm Description
1000 calorie diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Liquid formula low-calorie diet (LCD)
Other Intervention Name(s)
LCD, LED, Cambridge Weight Plan
Intervention Description
The liquid formula low-calorie diet (LCD) will provide 800kcal/day from powdered milkshakes and soups. The diet will be provided by Cambridge Weight Plan.
Intervention Type
Procedure
Intervention Name(s)
Roux-en-Y gastric bypass (RYGB)
Intervention Description
Participant went through Roux-en-Y gastric bypass (RYGB) surgery
Intervention Type
Other
Intervention Name(s)
Control diet
Primary Outcome Measure Information:
Title
Change in Intra-hepatocellular Lipid Content (IHCL) Following the Pre-operative Diet
Description
Intra-hepatocellular lipid content will be measured by magnetic resonance spectroscopy
Time Frame
at 2 weeks or 6 weeks depending on group
Secondary Outcome Measure Information:
Title
Change in Intra-hepatocellular Lipid Content (IHCL) Following Roux-en-Y Gastric Bypass
Description
Intra-hepatocellular lipid content (IHCL) will be compared between groups at 1 month following Roux-en-Y gastric bypass
Time Frame
at 1-month following Roux-en-Y gastric bypass
Title
Change in Intra-hepatocellular Lipid Content (IHCL) Following Roux-en-Y Gastric Bypass
Description
Intra-hepatocellular lipid content (IHCL) will be compared between groups at 6 months following Roux-en-Y gastric bypass
Time Frame
at 6 months following Roux-en-Y gastric bypass
Title
Complexity of Surgery
Description
Complexity of surgery will be assessed by the surgeon at the time of surgery (either after 2 weeks for the Control group and 2-week LCD group or after 6 weeks for the 6-week LCD group) The complexity of the surgery was assessed through a score on a complexity scale based on questionnaires previously published by Anders Thorell"s and David Edholm"s groups (Edholm et al., 2011, Van Nieuwenhove et al., 2011). The scores (1-5) for 7 variables: exposure, bleeding, difficulty in dissection, difficulty in reconstruction, surgical judgment, technical demand and psychological stress were combined into a complexity of surgery score with a minimum of 7 (very little complexity) and a maximum of 35 (very high complexity).
Time Frame
at the time of surgery
Title
Operative Time
Description
The operative time will be recorded at the time of surgery by the operating surgeon (either after 2 weeks for the Control group and 2-week LCD group or after 6 weeks for the 6-week LCD group)
Time Frame
at the time of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients undergoing Roux-en-Y gastric bypass at Imperial Weight Centre aged 18 to 60 years boby mass index of 35 to 55 kg/m2 Exclusion Criteria: Claustrophobia Pacemaker, metal implant, clips, implanted device, shrapnel or bullets, metal in eyes that precludes magnetic resonance imaging Current pregnancy or breast feeding for females (as determined by a pregnancy test) A full term pregnancy within the last year for females Treatment with any medication that might affect the study outcomes Haemorrhagic disorders and anticoagulant treatment History of cancer, excluding skin cancer History of severe or multiple allergies, severe adverse drug reaction or leucopenia Smokers Regular drinkers of more than three units of alcohol daily History of, or current evidence of, abuse of alcohol or any drug substance, licit or illicit Regular intake of over-the-counter (OTC) medication (other than the occasional paracetamol/aspirin) Poor compliers or subjects unlikely to commit to the 26 week study duration Blood donation within the 12 week period before the initial study dose Use of monoamine oxidase inhibitors (MAOIs) as anti depressant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof Gary S Frost, RD PhD
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial Clinical research facility
City
London
State/Province
Greater London
ZIP/Postal Code
W12 0NN
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Bottin JH, Balogun B, Thomas EL, Fitzpatrick JA, Moorthy K, Leeds AR, Bell JD, Frost GS. Changes in body composition induced by pre-operative liquid low-calorie diet in morbid obese patients undergoing Roux-en-Y gastric bypass. Obesity reviews (March 2014), 15 (suppl 2): 129-176. (T5:S24.05). doi: 10.1111/obr.12151
Results Reference
result

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Low-calorie Diet and Body Composition Prior to Roux-en-Y Gastric Bypass

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