Effects of an oral biodegradable device used for 12 weeks on weight reduction, cardiovascular risk factors, satiety, snacking, and meal size

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dc.contributor.authorShirin, Haim
dc.contributor.authorNeeland, Ian J.
dc.contributor.authorRyan, Donna H.
dc.contributor.authorde Luis, Daniel
dc.contributor.authorLecube Torelló, Albert
dc.contributor.authorMagos, Zoltan
dc.contributor.authorKenan, Yael
dc.contributor.authorAmir, Ruthie
dc.contributor.authorCohen, Daniel L.
dc.contributor.authorJohansen, Odd Erik
dc.date.accessioned2024-06-14T07:10:43Z
dc.date.available2024-06-14T07:10:43Z
dc.date.issued2023
dc.description.abstractBackground: The Epitomee Capsule (EC) is an, oral, self-use, bio-degradable device for weight management, composed of absorbent polymers that self-expands in the stomach (pH-sensitive) and creates a triangular shape, space-occupying super-absorbent gel structure. A recent study reported that 42 % of study completers obtained >5 % weight reduction at 12 weeks. We performed exploratory analyses of this study to evaluate its effect on cardiovascular risk factors and on self-reported satiety, between-meal snacking and meal-size. Methods: This single-center observational study (Israel) enrolled 78 volunteers, with mean age 41 years, BMI 32.5 kg/m2 , systolic/diastolic blood pressure (SBP/DBP) 124/77 mmHg. The EC was given in addition to diet and physical activity counseling. Assessments included anthropometrics, BP, lipids, and three questions (trans lated from Hebrew) scored 1 (not at all) to 5 (very much) for “Do you feel the EC - Q1:helps you to consume less snacks in between meals? Q2:helps you to eat less in the meal?; Q3:is causing an early sense of satiety?”. Changes from baseline were assessed using a mixed model and included all patients with at least one measure. Correlation-analysis between weight-change and PROs used Kendall’s tau. Result: Compared to baseline, at 12 weeks, SBP/DBP were reduced (ΔSBP: − 5.5 mmHg, p = 0.0003/ΔDBP: − 1.9 mmHg, p = 0.1341), with a larger effect in people with hypertension at baseline (ΔSBP: − 13.2 mmHg, p < 0.00001/ΔDBP: − 6.1, p = 0.008). Triglyceride-level was also significantly reduced, but not other lipids. Mean scores to Q1-3 were high throughout, with slight decreases (Q1 at W2 3.9 ± 1.1/W12 3.0 ± 1.6; Q2 at W2 3.7 ± 1.1/W12 3.1 ± 1.6; Q3 at W2 3.8 ± 1.2/W12 2.9 ± 1.6). There was a moderate correlation between PROs and weight reduction, although significance was not observed for all weeks. Conclusions: Exploratory analyses of 12 weeks treatment with EC demonstrated significant reductions in SBP, DBP, and triglycerides. The weight reduction correlated with satiety, less snacking, and reduced meal size.
dc.identifier.doihttps://doi.org/10.1016/j.obpill.2023.100094
dc.identifier.idgrec034284
dc.identifier.issn2667-3681
dc.identifier.urihttps://repositori.udl.cat/handle/10459.1/465958
dc.language.isoeng
dc.publisherElsevier
dc.relation.isformatofReproducció del document publicat a: https://doi.org/10.1016/j.obpill.2023.100094
dc.relation.ispartofObesity Pillars, 2023, vol. 8
dc.rightscc-by (c) authors, 2023
dc.rightsAttribution 4.0 International*
dc.rights.accessRightsinfo:eu-repo/semantics/openAccess
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/*
dc.subjectMedical device
dc.subjectWeight loss
dc.subjectObservational study
dc.subjectAppetite
dc.subjectGut-brain axis
dc.titleEffects of an oral biodegradable device used for 12 weeks on weight reduction, cardiovascular risk factors, satiety, snacking, and meal size
dc.typeinfo:eu-repo/semantics/article
dc.type.versioninfo:eu-repo/semantics/publishedVersion
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