Clinical Trials Directory

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

TypeNameDescription
DIETARY_SUPPLEMENTLiquid 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.
PROCEDURERoux-en-Y gastric bypass (RYGB)Participant went through Roux-en-Y gastric bypass (RYGB) surgery
OTHERControl 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.