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Completed

NCT Number: NCT02144597

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

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.

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Key information

Conditions

Morbid Obesity Body Weight Digestive System Diseases Fatty Liver Liver Diseases Liver Fat Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imperial Clinical research facility

London, Greater London, W12 0NN, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liquid formula low-calorie diet (LCD)

Dietary Supplement

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.

Other names: LCD, LED, Cambridge Weight Plan

Roux-en-Y Gastric Bypass (RYGB)

Procedure

Participant went through Roux-en-Y gastric bypass (RYGB) surgery

Control diet

Other

Primary outcomes

  1. Change in Intra-hepatocellular Lipid Content (IHCL) Following the Pre-operative Diet

    Time frame: at 2 weeks or 6 weeks depending on group

    Intra-hepatocellular lipid content will be measured by magnetic resonance spectroscopy

Secondary outcomes

  1. Change in Intra-hepatocellular Lipid Content (IHCL) Following Roux-en-Y Gastric Bypass

    Time frame: at 1-month 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

  2. Change in Intra-hepatocellular Lipid Content (IHCL) Following Roux-en-Y Gastric Bypass

    Time frame: at 6 months 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

  3. Complexity of Surgery

    Time frame: at the time 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).

  4. Operative Time

    Time frame: at the time of surgery

    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)

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Cambridge Weight Plan Limited

Registry information

Official study 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

Acronym: LCD

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
May 22, 2014
Registry last updated
Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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