Evidence map›Paper›PMID 33215362›Full record

Trial reportObesity surgery2021

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

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Obesity surgery, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 3 pooled it
1.0field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 3 syntheses or guidelines pooled it, 23 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 3 institutions in 2 countries.

Luigi SchiavoDepartment of Medicine, Surgery, and Dentistry, "Scuola Medica Salernitana", University of Salerno, Fisciano, SA, Italy. lschiavo@unisa.it.ORCID http://orcid.org/0000-0003-3639-6847
Giovanni De StefanoMed.Ita Advanced Biomedical Solutions, Naples, Italy.
Francesco PersicoUnit of General and Specialistic Surgery, A.O.R.N. dei Colli Ospedali Monaldi-Cotugno-CTO, Naples, Italy.
Stefano GargiuloGeneral Surgery Unit, Santa Maria La Bruna Clinic, Torre del Greco, Italy.
Federica Di SpiritoDepartment of Medicine, Surgery, and Dentistry, "Scuola Medica Salernitana", University of Salerno, Fisciano, SA, Italy.
Giulia GriguoloDepartment of Medicine, Surgery, and Dentistry, "Scuola Medica Salernitana", University of Salerno, Fisciano, SA, Italy.
Niccolò PetruccianiDigestive Unit, Archet 2 Hospital, University Hospital of Nice, F-06202, Nice, France.
Eric FontasDirection de la Recherche Clinique, University Hospital, Nice, France.
Antonio IannelliDigestive Unit, Archet 2 Hospital, University Hospital of Nice, F-06202, Nice, France.
Vincenzo PiloneDepartment of Medicine, Surgery, and Dentistry, "Scuola Medica Salernitana", University of Salerno, Fisciano, SA, Italy.
University of Salerno · ITInserm · FROspedale Monaldi · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Diet, KetogenicGastric BalloonObesity, MorbidBody CompositionCaloric RestrictionHumansReference StandardsWeight LossElipse™ intragastric balloonFat-free massLow-calorie ketogenic dietObesityResting metabolic rate

Identifiers

PMID33215362
PMCPMC8012342
OpenAlexW3105314539

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.