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Article

Acceptability of a Protein Oral Nutritional Supplement with Xanthan Gum in Patients with Neuromuscular Diseases and Dysphagia: A Cross-Sectional Study

Clinical Omnicenter for Neuromuscular Diseases, 60126 Ancona, Italy
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Author to whom correspondence should be addressed.
Gastrointest. Disord. 2025, 7(2), 34; https://doi.org/10.3390/gidisord7020034
Submission received: 8 November 2024 / Revised: 22 April 2025 / Accepted: 25 April 2025 / Published: 7 May 2025

Abstract

:
Background/Objectives: Oropharyngeal dysphagia (OD) is a prevalent symptom in patients with neuromuscular diseases (NMDs) and increases the risk of aspiration and malnutrition. Malnutrition is frequent in these patients and is not only related to dysphagia, but also generates a vicious circle that may result in worsening muscle atrophy and weakness. Texture modification is required to ensure safe and efficient swallowing. This study evaluates the acceptability of a ready-to-mix oral nutritional supplement (ONS) containing high-quality protein and a xanthan-based thickener in patients with OD and NMDs. Methods: This cross-sectional study includes adult patients with NMDs and OD who received a xanthan gum-based protein ONS. Patients completed a questionnaire to rate their satisfaction with the ONS. Results: Seventy-two patients were included (median age = 56 years; 51% were males). The percentage of patients with moderate-to-severe OD who rated the taste, consistency, and product quality as acceptable-to-very-satisfactory (score 3–5) were 76%, 80%, and 84%, respectively. After three months, 93% of patients continued consuming the ONS. Conclusions: Our findings support that the use of protein xanthan gum-based ONS can be as a palatable and an effective nutritional intervention, given their high satisfaction and acceptance rates among patients with NMDs and OD.

1. Introduction

Oropharyngeal dysphagia (OD) is a prevalent symptom in patients with neuromuscular diseases (NMDs) due to the progressive weakness and wasting of oral and pharyngeal muscles [1]. Previous epidemiological studies demonstrated that OD affects 36–58% and 47% of adults and children with NMDs, respectively [2,3]. OD commonly co-exists with other symptoms in patients with NMDs, such as dysarthria and respiratory impairment [4]. Despite its high prevalence, the diagnosis of OD is usually delayed as the patients often do not perceive the symptoms until the disease has progressed to advanced stages [5]. OD increases the risk of severe complications, including aspiration pneumonia, malnutrition, weight loss, and dehydration [4]. In particular, aspiration pneumonia and malnutrition are the most feared complications of OD due to the risk of institutionalization, hospitalization, respiratory failure, and mortality [4,6]. OD also significantly impacts patients’ quality of life (QoL) due to difficulty enjoying meals, socializing, and maintaining adequate nutrition [7]. The management of OD in patients with NMDs is multifaceted and aims to enhance patient safety, nutrition, and QoL [8,9].
Protein malnutrition is of particular concern in patients with NMDs and co-existing OD, as the resulting muscle atrophy, mobility impairment, and sarcopenia can further weaken the oral and pharyngeal muscles. This, in turn, exacerbates the patient’s eating difficulties, creating a vicious cycle of malnutrition and deteriorating OD [10]. Additionally, the underlying comorbidities of patients with OD often increase their daily protein requirements [11], which they may be unaware of or find challenging to meet. Ingesting sufficient protein is particularly difficult for patients with OD who require texture-modified diets [12]. Oral nutritional supplements (ONS) are typically added to the regular diet in patients with OD to help meet daily nutritional requirements and improve the intake of both macronutrients, such as protein and micronutrients [13]. However, in NMDs with co-existing OD, maintaining an adequate daily intake of calories and protein is complicated by the necessity for consistent dietary modifications.
In addition to ONS, the use of thickening liquids (TLs) is a frequent practice to improve the safety of swallowing in patients with OD by reducing aspiration risk [14]. TLs slow the bolus passage, potentially allowing for more time for a coordinated swallowing mechanism and less risk of airway penetration [15]. Although limited high-quality evidence supports the benefits of TLs [16], recent reports suggested that TLs reduce the risk of aspiration pneumonia and maintain hydration status in patients with OD [17,18].
Despite the benefits of TLs, unpalatability and low compliance are significant concerns. TLs may have an unappealing texture, taste, or appearance, causing patients to consume less fluid and affecting their enjoyment of meals and activities involving eating and drinking [19]. Consequently, adherence to the prescribed regimen may be reduced. Previous reports showed that up to 50% of patients with OD do not comply with the recommended TL regimen [20,21]. Poor compliance with TLs can negatively impact the effectiveness of OD management, leading to malnutrition, dehydration, and reduced QoL [9]. TLs may increase the risk of dehydration at higher viscosities due to low compliance (viscosity-dependent effect) [22,23]. Thus, it is crucial to ensure that TLs are both palatable and visually appealing to encourage patient compliance. Several types of thickeners exist (including starch-based, gum-based, and xanthan gum-based) to modify liquid consistency, with a variable impact on the viscosity and sensory perception of flavors. Xanthan gum-based thickeners have been increasingly used in commercial products due to their consistent texture, better stability at various temperatures, and resistance to salivary α-amylase [24]. The use of xanthan gum-based thickeners significantly improved compliance and dehydration due to acceptable texture perception and palatability [24,25].
The combination of a protein ONS with a xanthan gum-based thickener is considered an opportunity in the management of OD in patients with NMDs. By employing a xanthan gum-based protein ONS, healthcare professionals can achieve a two purposes: reducing the risk of aspiration being able to provide the appropriate product consistency and offering a protein supplement to prevent protein malnutrition. In the present study, we evaluated the acceptability of a novel thickened-protein ONS in patients with OD due to NMDs.

2. Results

A total of 72 patients were recruited. Of them, 40 patients had amyotrophic lateral sclerosis (ALS), 14 had myotonic dystrophy type 1 (DM1), 14 had Duchenne muscular dystrophy (DMD), and 4 had other NMDs. Table 1 presents the demographic and clinical characteristics of the study participants. The median age of the included patients was 56 (range: from 25 to 79) years, and 51% of the patients were males. The proportions of patients with ALS and DM1 were comparatively higher in the female compared to male patients. In terms of dysphagia severity, most patients (n = 53; 73.6%) had severe dysphagia, with a higher prevalence in patients with ALS (80%). Nearly 74% of the patients had severe aspiration risk.
Figure 1 shows the acceptability scores in the overall sample. The satisfaction scores were high, with a median ranging from 3 to 4 for all evaluated features. The median values are as follows: appearance and color: 3.9, fragrance: 3.5, taste: 3.2, consistency: 3.7, and quality: 3.6 (Table 2). Overall, 84% of the patients rated the appearance and color of the product as acceptable to very satisfactory (score 3–5). Similar percentages rated the fragrance (83%) and quality (78%) of the product as acceptable to very satisfactory. Nearly 65% of the patients had similar ratings for the taste and consistency of the product.
We also evaluated the satisfaction of the product in a subgroup of patients with moderate-to-severe dysphagia. Notably, the acceptability percentage improved, with more patients assigning a score of 5 (very satisfied) to all questions (see Figure 2). The median values for acceptability were as follows: appearance and color: 3.7, fragrance: 3.7, taste: 3.6, consistency: 3.7, and quality: 4. The majority of the patients with moderate-to-severe dysphagia reported being satisfied or very satisfied with the product, with the highest percentage of satisfaction (score 3–5) directed toward product quality (84%) and fragrance (83%). The percentage of patients who rated the taste, consistency, appearance/color as acceptable to very satisfactory (score 3–5) increased to 76%, 80%, and 80, respectively.
The reconstituted ONS was primarily consumed as a snack (38%), for breakfast (34%), or as a dessert (28%). At the 3-month follow-up, 93% of patients continued consuming the ONS at least once daily. We observed that the acceptability trend, in particular for consistency and quality, was similar across the various NMDs; However, the small sample size did not allow us to specifically determine differences in acceptability among the different NMDs. In contrast, taste and consistency received higher approval rating of among older patients (80% in those over patients > 60 years) and those with more severe dysphagia (84% in patients with severe dysphagia).

3. Materials and Methods

3.1. Study Design and Population

The present study is a cross-sectional study that recruited adult (age ≥ 18 years) patients with NMDs who were referred to a highly specialized tertiary care neuromuscular center between April and December 2023. Patients were deemed eligible if they had a concomitant diagnosis of OD according to clinical and instrumental assessments. Only patients with a Dysphagia Outcome and Severity Scale (DOSS) score [26] ranging from 3 to 5 (donating full per oral nutrition with a modified diet) were included. We included patients who were prescribed a xanthan gum-based protein ONS (ThickenUP® Protein Shake; Nestlé Health Science, Switzerland) as per the usual clinical practice. Patients were excluded if they had artificial nutrition, a tracheotomy, cognitive impairment, or an absence of a reliable caregiver. Patients admitted in residential facilities were also excluded. Eligible patients were classified into three groups based on the severity of OD according to the Mann Assessment of Swallowing Ability (MASA): mild, moderate, and severe OD [27]. This cross-sectional study was carried out in accordance with the principles of the Declaration of Helsinki and current Italian regulations on observational research.

3.2. Procedure and Data Collection

As per the usual clinical practice, each patient was provided with a moderately thickkened (International Dysphagia Diet Standardization Initiative [IDDSI] level 3 [28]) ONS that had specific nutritional features (Figure 3). The ONS can be mixed with either milk or water. It provides 19 g protein per 25 g product, when reconstituted with semi-skimmed milk, and 11 g when prepared with water (Table 3). The product is vanilla flavored, and based on xanthan gum. The product is a powder contained in 25 g single-dose sachets. To prepare a level 3 consistency on the IDDSI framework start by pouring one sachet into a cup or shaker, then add 250 mL semi-skimmed milk or 200 mL water. Next, stir vigorously for one minute, and allow the mixture to sit for 5 min (or 15 min when using milk) until it reaches the desired consistency. After tasting the product, patients completed a questionnaire to rate their satisfaction with various characteristics of the thickened ONS. The questionnaire used a scale from 1 (very unsatisfied) to 5 (very satisfied) and covered the following aspects: appearance and color of the reconstituted product, fragrance, taste, consistency, and overall quality (see Appendix A). Additionally, patients were asked to indicate their preferred time of day to consume the product, whether it is breakfast, dessert, or a snack. The following variables were also collected for each included patient: age, gender, diagnosis, and dysphagia severity.

3.3. Statistical Analysis

The Statistical analysis was performed using Excel for Windows. Continuous variables are presented as mean ± standard deviation (SD) or median with range according to data normality. Categorical data are presented as frequencies with their percentages.

4. Discussion

The management of nutritional care is an integral part of the multidisciplinary approach to NMDs. Nutritional care aims to prevent malnutrition, maintain adequate nutritional status, promote hemodynamic stability, reduce the rate of disease progression, and positively impact the quality of life and survival of patients with NMDs.
Nevertheless, systematic reviews and guidelines regarding nutritional care in NMDs are scarce, and some present gaps as they do not discuss specific aspects of nutritional treatment and management that should be implemented for this type of patient [29]. Liquid ONS are often used in clinical practice; however, there is lack of evidence in the literature on the acceptance of ONS by patients with NMDs and their actual adherence.
Furthermore, studies focusing on nutritional aspects do not take into account the concomitant occurrence of OD, thereby reducing the potential for proposing useful recommendations in clinical practice. This is particularly concerning because patients are often unable to take liquid supplements due to their rheological characteristics. Managing OD in patients with NMDs presents a complex challenge that requires a multifaceted approach to ensure swallowing safety, maintain adequate nutrition, and prevent dehydration.
In these patients, the risk of malnutrition may significantly increase if they do not adhere to a diet with modified food and fluid consistencies. In NMDs, OD needs to be treated early and regularly to prevent complications, particularly in patients who do not initially perceive the swallowing disorder.
There are no data describing the behavior adopted by patients with NMD due to of OD. Poor adherence to rheological modifications of foods and liquids in clinical practice is common among these patients, yet there are no descriptions in the literature concerning this issue. In a retrospective study aiming to investigate the clinical features associated with deteriorated swallowing in ALS, only 56% of patients used the suggested thickening agents. In total, 62% of those who refused the proposed thickeners died [30]. Additionally, a review on post-stroke dysphagia hypothesized that the decreased palatability of texture-modified diets may directly lead to inadequate intake [31].
TLs are a common intervention for managing OD, but concerns regarding unpalatability and low compliance are significant [20,21]. Several types of thickening agents, with variable components impact the rheological behavior as well as the characteristics and sensory of TLs [32]. Starch-based thickeners are commonly used to thicken liquids as they are relative affordability and wide availability. However, these thickeners are associated with increased viscosity [33], particularly in patients with NMDs due to impaired bolus propulsion [15]. Additionally, they showed inconsistent viscosity due to of their susceptibility to temperature changes, and are associated with a grainy texture and unfavorable flavor, affecting patients’ acceptability and compliance [25]. On the other hand, xanthan gum-based thickeners are characterized by better stability to temperature changes and resistance to salivary α-amylase [32]. Evidence also shows that xanthan gum-based thickeners are not associated with grainy textures, have a slicker oral perception, and are less sticky than starch-based thickeners [34]. Previous reports showed that xanthan gum-based thickener had a more preferred taste over starch-based thickeners [35]. It was also shown that xanthan gum-based thickener significantly improved swallowing safety without enhancing oropharyngeal residue [36].
A ready-to-mix ONS with a xanthan-based thickener and high-quality protein offers clinicians a valuable opportunity, particularly in managing nutritional care for chronic progressive neurological diseases such as NMDs. By employing protein-enhanced xanthan gum-based ONS, healthcare professionals can achieve two purposes: reducing the risk of aspiration being able to provide the appropriate product consistency and offering a protein supplement to prevent protein malnutrition. An additional advantage of the xanthan gum-based protein ONS used in this study is the quality of the protein it contains. Whey protein, a key product component, represents a newly emerging class of biological substances with potential benefits for human health [37]. Whey protein has been shown to promote muscle protein synthesis and reduce muscle breakdown [38], which can help preserve muscle mass and function in patients with NMDs. This is particularly important for individuals who may have difficulty maintaining adequate protein intake due to dysphagia. This study evaluates the acceptability of a xanthan gum-based ONS with a high-quality protein content (11 g when reconstituted with 250 mL of water or 19 g with semi-skimmed milk/25 g product).
Our findings suggest that the flavored high-protein quality xanthan gum-based ONS was acceptable and satisfactory for patients with OD and NMDs. The product was rated as acceptable to very satisfactory by the vast majority of patients concerning appearance, fragrance, taste, consistency, and quality. Additionally, 93% of the patients, at the end of the follow-up period, kept consuming the product, highlighting its high acceptability. We observed that the acceptability trend, in particular for consistency and quality, was similar for the NMDs. In clinical practice, even xanthan gum-based thickeners could be perceived as difficult to manage in the same conditions as DMD. In our experience, DMD patients have shown good acceptability in line with the paper by Rofes et al. [36], which describes that certain types of xanthan gum-based thickeners do not increase residue, providing a viscosity-dependent therapeutic effect also in patients with neurodegenerative diseases. The small sample of DMD patients in our population limits the remark. Although limited evidence investigated the patient report satisfaction and acceptability of this ONS in the NMD setting, our findings align with previous reports that showed satisfaction with the use of xanthan gum-based TLs in patients with OD [39]. In a previous report, 95% of nursing staff reported satisfaction with using xanthan gum-based thickener, as the thickener was associated with increased fluid intake and high patient acceptability and satisfaction [40]. A recent real-world experience also showed high acceptability with xanthan gum-based TLs in patients with post-stroke OD [17].
The majority of patients in the present study expressed satisfaction with the flavored high-protein quality, xanthan gum-based ONS. Although we described a difference in satisfaction between patients with mild and moderate–severe dysphagia, the small size of the mild group limited our ability to make meaningful comparisons between different groups.
Opinions diverged regarding the product’s flavoring, which is only available in vanilla. The overall population and the moderate to severe OD subgroup had participants who liked the flavor and others who disliked it. Despite these varying opinions on taste, all participants acknowledged the product’s suitability for individuals with swallowing difficulties and expressed satisfaction with its protein content, highlighting its nutritional benefits. This suggests that, while flavor preferences are subjective, the product’s overall utility and nutritional profile are well-regarded.
In the present study, we evaluated a xanthan gum-based ONS with a high protein content. Although this study did not evaluate changes in the nutritional status of the patients, the product contains high-quality whey protein, which has been shown to promote muscle protein synthesis and reduce muscle breakdown [38]. Therefore, it is anticipated that patients in this study benefited from the nutritional value of the xanthan gum-based protein ONS, especially given the observed high satisfactory and acceptability rate. The high satisfaction rate among different NMDs and the high acceptance of different characteristics of the ONS support its potential nutritional benefits in our cohort.
The present study is one of a few reports that evaluated the satisfactory and acceptability of ONS with xanthan gum-based thickeners, particularly in patients with NMDs. However, we acknowledge the existence of certain limitations. First, the sample size was relatively small, which may limit the generalizability of the findings. The study was also conducted at a single center, further limiting its generalizability. Additionally, the sample was heterogeneous and included various NMDs; the small number of patients for each condition did not allow us to compare the acceptability across different NMDs. Finally, this study does not include a control group, which limits the ability to know how the acceptability of the flavored, high-protein xanthan gum-based protein ONS compares to other ONS.

5. Conclusions

In conclusion, the flavored, high-quality protein xanthan gum-based ONS was found to be satisfactory and acceptable by patients with OD and NMDs, as confirmed by continued use over a three-month period. Patients expressed high satisfaction regarding the appearance, fragrance, taste, consistency, and overall quality of the reconstituted product. Considering the paucity of data on adherence to ONS intake in patients with NMDs and OD, further studies with large sample sizes are needed to confirm our findings.

Author Contributions

Conceptualization, F.F. and M.C.; validation, F.F. and M.C.; formal analysis, F.F. and M.C.; investigation, F.F., L.C. and M.C.; writing—review and editing, F.F., L.C. and M.C. All authors have read and agreed to the published version of the manuscript.

Funding

The author retains the editorial process, including the discussion, at all times. Content Ed Net Switzerland provided editorial and medical writing assistance for the preparation of this manuscript; this assistance was funded by Nestlé Health Science. All medical writing activities followed the 2022 Good Publication Practice (GPP 2022) guidelines update. The views and opinions expressed are those of the authors.

Institutional Review Board Statement

This cross-sectional study, conducted as a survey aimed at evaluating the acceptability of a product already used in the center and by patients, was carried out in accordance with the principles of the Declaration of Helsinki and current Italian regulations on observational research. The data were processed anonymously and confidentially to ensure privacy protection and compliance with personal data protection regulations (EU Regulation 2016/679—GDPR). No personal names were collected, no cookies were used to assign a user identifier, and the IP address of respondents was not checked. We specified in the introduction to the survey that the data were collected for research purposes. Participation in the survey was free and voluntary; participants actively chose to respond.

Informed Consent Statement

Informed consent was obtained from all subjects involved in the study.

Data Availability Statement

The raw data supporting the conclusions of this article will be made available by the authors on request.

Acknowledgments

Content Ed Net Switzerland provided medical writing and editorial support in preparing this paper.

Conflicts of Interest

The authors declare no conflicts of interest.

Appendix A

THICKENED PROTEIN ONS LIKING QUESTIONNAIRE
We ask you to take a few minutes of your time to fill out the following questionnaire regarding the proposed thickened beverage.
  • How do you evaluate the appearance and color of the reconstituted product?
Very dissatisfiedVery satisfied
12345
2.
How do you evaluate the scent of the reconstituted product?
Very dissatisfiedVery satisfied
12345
3.
How do you rate the taste of the reconstituted product?
Very dissatisfiedVery satisfied
12345
4.
Is the consistency of the product, in the sense of density, adequate for your needs?
Very dissatisfiedVery satisfied
12345
5.
Are you satisfied with the quality of the product?
Very dissatisfiedVery satisfied
12345
6.
In your opinion, at what time of day do you think it is most appropriate to use?
(a)
Breakfast.
(b)
Dessert.
(c)
Snack.

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Figure 1. Responses to the acceptability questionnaire in the overall cohort.
Figure 1. Responses to the acceptability questionnaire in the overall cohort.
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Figure 2. Responses to the acceptability questionnaire in patients with moderate-to-severe dysphagia.
Figure 2. Responses to the acceptability questionnaire in patients with moderate-to-severe dysphagia.
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Figure 3. Illustration of the reconstituted, vanilla-flavored ONS.
Figure 3. Illustration of the reconstituted, vanilla-flavored ONS.
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Table 1. Demographic and clinical characteristics of study participants.
Table 1. Demographic and clinical characteristics of study participants.
Overall (n = 72)ALS (n = 40)DMD (n = 14)DM1 (n = 14)Others (n = 4)
Average age, years56 (25–79)76 (53–79)30 (25–35)50 (41–58)68 (65–72)
Gender
Male37 (51.3%)15 (37.5%)14 (100%)6 (42.8%)2 (50%)
Female35 (48.7%)25 (62.5%)08 (57.1%)2 (50%)
Dysphagia severity (MASA)
Mild (score 168–177)7 (9.7%)3 (7.5%)2 (14.2%)2 (14.2%)0
Moderate (score 139–167)12 (16.6%)5 (12.5%)4 (28.5%)3 (21.4%)0
Severe (139–167)53 (73.6%)32 (80%)8 (57.1%)9 (64.2%)4 (100%)
Dysphagia risk aspiration (MASA)
Mild (149–169)8 (11.1%)2 (5%)3 (21.4%)3 (21.4%)0
Moderate (141–148)11 (15.3%)6 (15%)3 (21.4%)2 (14.3%)0
Severe (≤140)53 (73.6%)32 (80%)8 (57.1%)9 (64.2%)4 (100%)
MASA: Mann Assessment of Swallowing Ability.
Table 2. Acceptability scores in the overall sample and in patients with moderate to severe dysphagia.
Table 2. Acceptability scores in the overall sample and in patients with moderate to severe dysphagia.
Median ValueOverall Cohort
(n = 72)
Patients with Moderate-to-Severe Dysphagia
(n = 65)
Appearance and color3.93.7
Fragrance3.53.7
Taste3.23.6
Consistency3.73.7
Quality3.64
Table 3. Nutritional information of the vanilla-flavored, xanthan gum-based protein ONS.
Table 3. Nutritional information of the vanilla-flavored, xanthan gum-based protein ONS.
Nutritional Information 100 g25 g + 250 mL Milk *25 g
+ 200 mL Water
Energykcal/kJ360/1508209/87690/377
Proteing441911
Whey proteing441911
Lipidsg0.804.10.20
Saturated fatty acidsg0.202.40.05
Carbohydratesg412310.3
Sugarsg16164.0
Fibersg6.61.71.7
Saltg1.30.590.31
Sodiummg500235125
* Semi- skimmed (1.5%).
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MDPI and ACS Style

Felloni, F.; Costantini, L.; Coccia, M. Acceptability of a Protein Oral Nutritional Supplement with Xanthan Gum in Patients with Neuromuscular Diseases and Dysphagia: A Cross-Sectional Study. Gastrointest. Disord. 2025, 7, 34. https://doi.org/10.3390/gidisord7020034

AMA Style

Felloni F, Costantini L, Coccia M. Acceptability of a Protein Oral Nutritional Supplement with Xanthan Gum in Patients with Neuromuscular Diseases and Dysphagia: A Cross-Sectional Study. Gastrointestinal Disorders. 2025; 7(2):34. https://doi.org/10.3390/gidisord7020034

Chicago/Turabian Style

Felloni, Federica, Luca Costantini, and Michela Coccia. 2025. "Acceptability of a Protein Oral Nutritional Supplement with Xanthan Gum in Patients with Neuromuscular Diseases and Dysphagia: A Cross-Sectional Study" Gastrointestinal Disorders 7, no. 2: 34. https://doi.org/10.3390/gidisord7020034

APA Style

Felloni, F., Costantini, L., & Coccia, M. (2025). Acceptability of a Protein Oral Nutritional Supplement with Xanthan Gum in Patients with Neuromuscular Diseases and Dysphagia: A Cross-Sectional Study. Gastrointestinal Disorders, 7(2), 34. https://doi.org/10.3390/gidisord7020034

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