Morbid ObesityLCDNCT02144597
Low-calorie Diet and Body Composition Prior to Roux-en-Y Gastric Bypass
A study testing Liquid formula low-calorie diet (LCD) and Roux-en-Y gastric bypass (RYGB) in people with Morbid Obesity and Liver Fat, run by Imperial College London at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Morbid Obesity, Liver Fat
- What is being tested?
- Liquid formula low-calorie diet (LCD) and Roux-en-Y gastric bypass (RYGB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2011to Apr 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial Clinical research facility
London, Greater London, W12 0NN
About this study
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
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.
Read the 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.
- Conditions
- Morbid Obesity, Liver Fat
- Being tested
- Liquid formula low-calorie diet (LCD), Roux-en-Y gastric bypass (RYGB), Control diet
- Keywords
- morbid obesity, gastric bypass, bariatrics, diet, caloric restriction, liver fat, appetite
- Medical subject headings
- Obesity, Morbid, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid formula low-calorie diet (LCD)Dietary supplement
Also called LCD, LED, Cambridge Weight Plan
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)Procedure or surgery
Participant went through Roux-en-Y gastric bypass (RYGB) surgery
Control dietOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Liquid formula low-calorie diet (LCD) |
| Control diet | Other | 1000 calorie diet Receives: Procedure: Roux-en-Y gastric bypass (RYGB); Other: Control diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intra-hepatocellular Lipid Content (IHCL) Following the Pre-operative Diet
Intra-hepatocellular lipid content will be measured by magnetic resonance spectroscopy
Measured: 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
Intra-hepatocellular lipid content (IHCL) will be compared between groups at 1 month following Roux-en-Y gastric bypass
Measured: 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
Measured: 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).
Measured: at the time of surgery
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)
Measured: at the time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study startAug 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge Weight Plan Limited
- Responsible party
- Sponsor
- Investigators
- Prof Gary S Frost, RD PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144597
- Sponsor's protocol ID
- CRO1668
- Acronym
- LCD
- Status last verified
- Feb 2021
- First submitted
- 9 May 2014
- Last updated
- 18 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02144597
- Acronym / sponsor ID
- LCD / CRO1668
- Conditions
- Morbid Obesity, Liver Fat
- Keywords
- morbid obesity, gastric bypass, bariatrics, diet, caloric restriction, liver fat, appetite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Cambridge Weight Plan Limited
- Study start
- Aug 2011 (actual)
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 22 May 2014 (estimated)
- Results
- Posted 18 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2-week LCD and Roux-en-Y gastric bypass (RYGB) | Active comparator | Dietary Supplement: Liquid formula low-calorie diet (LCD), Procedure: 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 |
| 6-week LCD | Active comparator | Dietary Supplement: Liquid formula low-calorie diet (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 |
| Control diet | Other | Procedure: Roux-en-Y gastric bypass (RYGB), Other: Control diet1000 calorie diet |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liquid formula low-calorie diet (LCD)Also: LCD, LED, Cambridge Weight PlanThe liquid formula low-calorie diet (LCD) will provide 800kcal/day from powdered milkshakes and soups. The diet will be provided by Cambridge Weight Plan. | Dietary supplement | 2-week LCD and Roux-en-Y gastric bypass (RYGB), 6-week LCD |
| Roux-en-Y gastric bypass (RYGB)Participant went through Roux-en-Y gastric bypass (RYGB) surgery | Procedure or surgery | 2-week LCD and Roux-en-Y gastric bypass (RYGB), Control diet |
| Control diet | Other | Control diet |
Primary outcome
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
4 secondary outcomes
Change in Intra-hepatocellular Lipid Content (IHCL) Following Roux-en-Y Gastric Bypass
Time frame: at 1-month following Roux-en-Y gastric bypass
Change in Intra-hepatocellular Lipid Content (IHCL) Following Roux-en-Y Gastric Bypass
Time frame: at 6 months following Roux-en-Y gastric bypass
Complexity of Surgery
Time frame: at the time of surgery
Operative Time
Time frame: at the time of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationBottin 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
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof Gary S Frost, RD PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liquid formula low-calorie diet (LCD) and Roux-en-Y gastric bypass (RYGB) in people with Morbid Obesity and Liver Fat, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Intra-hepatocellular Lipid Content (IHCL) Following the Pre-operative Diet (time frame: at 2 weeks or 6 weeks depending on group). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02144597, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.