Trials / Completed
CompletedNCT02144597
Low-calorie Diet and Body Composition Prior to Roux-en-Y Gastric Bypass
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Imperial College London · Academic / Other
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | 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. |
| PROCEDURE | Roux-en-Y gastric bypass (RYGB) | Participant went through Roux-en-Y gastric bypass (RYGB) surgery |
| OTHER | Control diet |
Timeline
- Start date
- 2011-08-01
- Primary completion
- 2014-04-01
- Completion
- 2014-04-01
- First posted
- 2014-05-22
- Last updated
- 2021-03-18
- Results posted
- 2021-03-18
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02144597. Inclusion in this directory is not an endorsement.