TY - JOUR
T1 - Effects of an oral biodegradable device used for 12 weeks on weight reduction, cardiovascular risk factors, satiety, snacking, and meal size
AU - Shirin, Haim
AU - Neeland, Ian J.
AU - Ryan, Donna H.
AU - de Luis, Daniel
AU - Lecube, Albert
AU - Magos, Zoltan
AU - Kenan, Yael
AU - Amir, Ruthie
AU - Cohen, Daniel L.
AU - Johansen, Odd Erik
N1 - Publisher Copyright:
© 2023 The Authors
PY - 2023/12
Y1 - 2023/12
N2 - Background: 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 (translated 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.
AB - Background: 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 (translated 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.
KW - Appetite
KW - Gut-brain axis
KW - Medical device
KW - Observational study
KW - Weight loss
UR - http://www.scopus.com/inward/record.url?scp=85192210841&partnerID=8YFLogxK
U2 - 10.1016/j.obpill.2023.100094
DO - 10.1016/j.obpill.2023.100094
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C2 - 38125654
AN - SCOPUS:85192210841
SN - 2667-3681
VL - 8
JO - Obesity Pillars
JF - Obesity Pillars
M1 - 100094
ER -