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

NCT02144597 | Completed Results DMC

• 1 other identifier: CRO1668
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity; Liver Fat

Keywords

morbid obesity; gastric bypass; bariatrics; diet; caloric restriction; liver fat; appetite

Outcome Measures

Primary Outcomes (1)

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

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

  at 2 weeks or 6 weeks depending on group

Secondary Outcomes (4)

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

  at 1-month following Roux-en-Y gastric bypass

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

  at 6 months following Roux-en-Y gastric bypass

• Complexity of Surgery

  at the time of surgery

• Operative Time

  at the time of surgery

Study Arms (3)

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

ACTIVE COMPARATOR

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

Dietary Supplement: Liquid formula low-calorie diet (LCD); Procedure: Roux-en-Y gastric bypass (RYGB)

6-week LCD

ACTIVE COMPARATOR

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

Dietary Supplement: Liquid formula low-calorie diet (LCD)

Control diet

OTHER

1000 calorie diet

Procedure: Roux-en-Y gastric bypass (RYGB); Other: Control diet

Interventions

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.

Also known as: LCD, LED, Cambridge Weight Plan

2-week LCD and Roux-en-Y gastric bypass (RYGB); 6-week LCD

Roux-en-Y gastric bypass (RYGB) PROCEDURE

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

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

Control diet OTHER

Control diet

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• Cambridge Weight Plan Limited: collaborator

Study Sites (1)

Imperial Clinical research facility

London, Greater London, W12 0NN, United Kingdom

Location

Related Publications (1)

• 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

  RESULT

MeSH Terms

Conditions

Obesity, Morbid; Fatty Liver

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Results Point of Contact

• Title: Prof Gary Frost
• Organization: Imperial College London

g.frost@imperial.ac.uk

07872850308

Study Officials

• Prof Gary S Frost, RD PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2014
• First Posted: May 22, 2014
• Study Start: August 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: March 18, 2021
• Results First Posted: March 18, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)