A Randomized, Controlled Trial Comparing the Impact of a Low-Calorie Ketogenic vs a Standard Low-Calorie Diet on Fat-Fre
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ORIGINAL CONTRIBUTIONS
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™ Intragastric Balloon Treatment Luigi Schiavo 1,2 & Giovanni De Stefano 3 & Francesco Persico 4 & Stefano Gargiulo 5 & Federica Di Spirito 1 & Giulia Griguolo 1 & Niccolò Petrucciani 6 & Eric Fontas 7 & Antonio Iannelli 6,8,9 & Vincenzo Pilone 1,2 Received: 27 April 2020 / Revised: 5 November 2020 / Accepted: 10 November 2020 # The Author(s) 2020
Abstract Background The 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. Objective To 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. Methods WL, 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. Results The 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.
* Luigi Schiavo [email protected] Giovanni De Stefano [email protected] Francesco Persico [email protected] Stefano Gargiulo [email protected] Federica Di Spirito [email protected]
Vincenzo Pilone [email protected] 1
Department of Medicine, Surgery, and Dentistry, “Scuola Medica Salernitana”, University of Salerno, Fisciano, SA, Italy
2
Center of Excellence of Bariatric Surgery of the Italian Society of Obesity Surgery and Metabolic Disease (SICOB), Unit of General and Emergency Surgery, University Hospital San Giovanni di Dio e Ruggi d’Aragona, Mercato San Severino, Salerno, Italy
3
Med.Ita Advanced Biomedical Solutions, Naples, Italy
4
Unit of General and Specialistic Surgery, A.O.R.N. dei Colli Ospedali Monaldi-Cotugno-CTO, Naples, Italy
5
General Surgery Unit, Santa Maria La Bruna Clinic, Torre del Greco, Italy
6
Digestive Unit, Archet 2 Hospital, University Hospital of Nice, F-06202 Nice, France
7
Direction de la Recherche Clinique, University Hospital, Nice, France
8
Inserm, U1065, Team 8 “Hepatic Complications of Obesity”, F-06204 Nice, France
9
University of Nice Sophia-Antipolis, F-06107 Nice, France
Giulia Griguolo [email protected] Ni
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