Award: ACG Outstanding Research Award in the Small Intestine Category
Award: Presidential Poster Award
Ali Rezaie, MD1, Bianca W. Chang, MD2, Krystyna Houser, 3, Ava Hosseini, MPH1, Daniel H. Brimberry, PhD2, Mohamad Rashid, MD1, Ruchi Mathur, MD1, Sepideh Mehravar, MD1, Yin Chan, MD2, Gabriela Leite, PhD1, Walter Morales, 1, Maritza Sanchez, 1, Coka Yip, NP2, Stacy Weitsman, MS1, Cristina M. Fajardo, MSc1, Ignacio Rivera, 1, Jiajing Wang, PhD4, Gillian M. Barlow, PhD1, Jason Nasser, MD2, Amrit K.. Kamboj, MD2, Jane Lim, MD2, Christine L.. Scarcello, MS, RD2, Mark Pimentel, MD1 1Cedars-Sinai Medical Center, West Hollywood, CA; 2Cedars-Sinai Medical Center, Los Angeles, CA; 3mBiota, Santa Monica, CA; 4Cedars-Sinai Medical Center, San Jose, CA
Introduction: Elemental diets (EDs) are complete meal replacements containing the required daily allowance of vitamins, major/trace minerals, fat, amino acids, and carbohydrates. EDs have desirable safety and efficacy profiles in several clinical settings including but not limited to Crohn’s disease, eosinophilic esophagitis/gastroenteritis, and small intestinal bacterial overgrowth (SIBO). Palatability remains the main barrier to using complete EDs in clinical practice and results in significant poor compliance in pediatric and adult populations. In this prospective trial, we aimed to blindly assess the organoleptic acceptability of a novel palatable elemental diet (PED) in comparison to a commercially-available elemental diet (CED).
Methods: Adult subjects with intestinal methanogen overgrowth or SIBO undergoing two weeks of exclusive PED (mBiota Elemental, USA) were recruited (NCT05978973). On the initial visit, participants blindly tasted and assessed PED and Vivonex Plus (Nestle, USA) (CED). Formulations were prepared as per manufacturer’s recommendations. Order of tasting was randomly assigned. Participants were asked about their preference between the two formulas and rated the organoleptic characteristics (appearance, smell, taste, aftertaste, and consistency) along with their overall impression of each formulation using a 7-point Likert scale: 1) Like a lot, 2) Like moderately, 3) Like a little, 4) Neither like nor dislike, 5) Dislike a little, 6) Dislike moderately, 7) Dislike a lot. McNemar’s test was used for comparison of paired nominal data.
Results: A total of 30 subjects were included (63% women, median (range) age 45 (23-73) years). When asked “Which, if either, of these two shake products tastes better?”, all 30 subjects (100%) preferred PED over CED. As compared to CED, the proportion of subjects who liked or were neutral to the PED (Likert scale 1-4) was significantly higher for all organoleptic characteristics: Appearance (90% vs 63.3%, p=0.027), smell (86.7% vs 6.7%, p< 0.001), taste (86.7% vs 0%, p< 0.001), aftertaste (73.3% vs 6.7%, p< 0.001), consistency (90% vs 53.3%, p=0.006), and overall impression (83.3% vs 0%, p< 0.001) (Figure 1). All 30 subjects (100%) completed the 2-week treatment regimen with exclusive PED.
Discussion: In this prospective, single-blind comparative study, a novel palatable ED formulation was organoleptically more acceptable compared to a conventional ED and led to optimal compliance during a 2-week exclusive ED therapy.
Figure: Figure 1. Head-to-head comparison of five organoleptic characteristics along with overall impression of palatable elemental diet (PED) compared to a commercially-available elemental diet (CED) based on a 7-point Likert scale.
Disclosures:
Ali Rezaie: Ardelyx – Consultant. Bausch Health – Consultant, Speakers Bureau. Gemelli Biotech – Stock-privately held company. GoodLFE – Stock-privately held company.
Bianca Chang indicated no relevant financial relationships.
