A Randomized, Controlled Trial Comparing the Impact of a Low-Calorie Ketogenic vs a Standard Low-Calorie Diet on Fat-Free Mass in Patients Receiving an Elipse\u2122 Intragastric Balloon Treatment

Giulia Griguolo,Stefano Gargiulo,Antonio Iannelli,Luigi Schiavo,Francesco Persico,Niccolò Petrucciani,Eric Fontas,Vincenzo Pilone,Federica Di Spirito,Giovanni De Stefano

doi:10.1007/s11695-020-05133-8

Abstract

BackgroundThe Elipse™ intragastric balloon (EIGB) is a new swallowable balloon for weight loss (WL). Preserving metabolically active fat-free mass (FFM) and resting metabolic rate (RMR) during WL are crucial to maximize fat mass (FM) loss. After EIGB placement, a standard low-calorie diet (LCD) is generally prescribed. A low-calorie ketogenic diet (LCKD) has proven to be safe and effective in reducing FM while preserving FFM and RMR.ObjectiveTo prospectively compare the effects on WL, FM, FFM, and RMR in two groups of patients who were randomized to two different diets: LCKD and a standard LCD after EIGB placement.MethodsWL, FM, FFM, and RMR were measured before EIGB and at 4 months in 48 patients who received either a LCKD (n = 24) or a standard LCD (n = 24). Compliance in following the prescribed diet was determined with food frequency questionnaires in all patients. The impact of LCKD and LCD on renal function was also evaluated.ResultsThe LCKD group showed a significantly lower decrease in FFM and RMR when compared with the LCD group (3.55 vs 14.3%, p < 0.001; 9.79 vs 11.4%, p < 0.001, respectively). FM decreased more significantly with LCKD compared to LCD (41.6 vs 33.1%, p = 0.0606). Compliance in following the prescribed diets, without negative impact on renal function, was found.ConclusionBased on our findings, despite the small sample size, we were able to support the hypothesis that LCKD is associated with an increased FM loss while reducing the FFM loss and the RMR, without interfering with renal function after EIGB.

Highlights

Intragastric balloons have been used for weight loss (WL) in the last two decades, but the need for hospital recovery, upper GI endoscopy, and anesthesia is major limitations for this technique
Based on our findings, despite the small sample size, we were able to support the hypothesis that low-calorie ketogenic diet (LCKD) is associated with an increased fat mass (FM) loss while reducing the fat-free mass (FFM) loss and the resting metabolic rate (RMR), without interfering with renal function after ElipseTM intragastric balloon (EIGB)
Before EIGB placement, LCKD and low-calorie diet (LCD) groups were comparable in terms of body weight (BW), FM, and FFM (p = 0.227, 0.496, and 0.463, respectively) whereas RMR was significantly higher in the LCKD group (p = 0.0232) (Table 3)

Summary

Introduction

Intragastric balloons have been used for weight loss (WL) in the last two decades, but the need for hospital recovery, upper GI endoscopy, and anesthesia is major limitations for this technique. The ElipseTM intragastric balloon (EIGB) is a new swallowable balloon that has no such limitations and has been proven to be safe, effective in achieving weight loss is and well tolerated by patients [1,2,3,4,5,6]. After EIGB placement, a standard low-calorie diet (LCD) program, based on a daily intake of about 1000–1200 kcal/ day, is generally prescribed [6]. The combination of the restrictive effect of EIGB and diet accounts for a significant loss of fatty free mass (FFM). ElipseTM intragastric balloon (EIGB) is a new swallowable balloon for weight loss (WL). After EIGB placement, a standard low-calorie diet (LCD) is generally prescribed. A low-calorie ketogenic diet (LCKD) has proven to be safe and effective in reducing FM while preserving FFM and RMR

Methods

Results

Discussion

Conclusion