Low-calorie Diet and Body Composition Prior to Roux-en-Y Gastric Bypass
NCT ID: NCT02144597
Last Updated: 2021-03-18
Study Results
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View full resultsBasic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2011-08-31
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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2-week LCD and Roux-en-Y gastric bypass (RYGB)
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
Liquid formula low-calorie diet (LCD)
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.
Roux-en-Y gastric bypass (RYGB)
Participant went through Roux-en-Y gastric bypass (RYGB) surgery
6-week LCD
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
Liquid formula low-calorie diet (LCD)
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.
Control diet
1000 calorie diet
Roux-en-Y gastric bypass (RYGB)
Participant went through Roux-en-Y gastric bypass (RYGB) surgery
Control diet
Interventions
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Liquid formula low-calorie diet (LCD)
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.
Roux-en-Y gastric bypass (RYGB)
Participant went through Roux-en-Y gastric bypass (RYGB) surgery
Control diet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* aged 18 to 60 years
* boby mass index of 35 to 55 kg/m2
Exclusion Criteria
* 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
18 Years
60 Years
ALL
No
Sponsors
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Cambridge Weight Plan Limited
INDUSTRY
Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Prof Gary S Frost, RD PhD
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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Imperial Clinical research facility
London, Greater London, United Kingdom
Countries
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References
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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
Other Identifiers
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CRO1668
Identifier Type: -
Identifier Source: org_study_id
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