Nutrition-dense Smoothie Diets Reduced Dysphagia Risk in the Elderly

Study Overview
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Brief Summary
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The investigators aimed to compare the effect of consuming high protein (23-34% energy ratio) and low carbohydrate (25-38% energy ratio) smoothie formulas vs. consuming Ensure (a conventional well-known commercial formula) on the swallowing capacity by using Flexible Endoscopic Evaluation of Swallowing (FEES) in the elderly people with dysphagia risk.

Detailed Description
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The investigators aimed to determine the effect of 3 high protein (23-34% energy ratio) and low carbohydrate (25-38% energy ratio) smoothie formulas ((1) white sesame soy milk smoothie (WS), (2) black sesame soy milk smoothie (low carbohydrate, BSLC), and (3) Chicken shitake smoothie (CS); 1 kcal/ml) from natural ingredients as compared with Ensure. The double blind randomized placebo controlled cross-over design study involved 63 subjects aged above 65 years old. They were also divided into asymptomatic (n=32) or symptomatic swallowing difficulty (n=31) group based on self-reported swallowing difficulty symptoms. All subjects assessed five drinks (WS, BSLC, CS vs. Ensure) for sensory testing, product acceptance and marketing survey using questionnaires. Swallowing capacity was determined by using Flexible Endoscopic Examination of Swallowing (FEES) only for each of the three drinks (SW, CS vs. Ensure) in a blinded random sequence.

Official Title
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The Effect of Nutrition-dense, Blenderized Enteral Nutrition From Natural Ingredients on Swallowing Capacity to Prevent Suffocation in the Elderly by Using Flexible Endoscopic Examination of Swallowing (FEES)

Conditions
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Dysphagia

Intervention / Treatment
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* Diagnostic Test: the effect of consuming diets on the swallowing capacity by using Flexible Endoscopic Evaluation of Swallowing (FEES)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: swallowing difficulty group (SSD) who with symptomatic swallowing difficulties or with a history of swallowing difficulties, coughing or choking when eating or drinking or a sign of malnutrition control group (WSD) who without a history of swallowing difficulties, coughing or choking when eating or drinking or a sign of malnutrition Exclusion Criteria: People with chronic illnesses and tube feeding People with anterior bone deformity e.g. facial fracture, sino-nasal or anterior skill-based tumor/surgery

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: White sesame soy milk smoothie (WS)<br>a formula developed from natural ingredients such as soybean and white sesame | Diagnostic Test: the effect of consuming diets on the swallowing capacity by using Flexible Endoscopic Evaluation of Swallowing (FEES)<br>* the effect of consuming white sesame soy milk smoothie (WS), Chicken shitake smoothie (CS) vs. Ensure on the swallowing capacity by using Flexible Endoscopic Evaluation of Swallowing (FEES)<br>|
| Active Comparator: Chicken shitake smoothie (CS)<br>a formula developed from natural ingredients such as chicken and shitake mushroom | Diagnostic Test: the effect of consuming diets on the swallowing capacity by using Flexible Endoscopic Evaluation of Swallowing (FEES)<br>* the effect of consuming white sesame soy milk smoothie (WS), Chicken shitake smoothie (CS) vs. Ensure on the swallowing capacity by using Flexible Endoscopic Evaluation of Swallowing (FEES)<br>|
| Placebo Comparator: Ensure<br>a conventional well-known commercial formula | Diagnostic Test: the effect of consuming diets on the swallowing capacity by using Flexible Endoscopic Evaluation of Swallowing (FEES)<br>* the effect of consuming white sesame soy milk smoothie (WS), Chicken shitake smoothie (CS) vs. Ensure on the swallowing capacity by using Flexible Endoscopic Evaluation of Swallowing (FEES)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of severity of dysphagia as assessed by a healthcare professional using the FEES | Sum of FEES score from three symptoms consists of premature spillage of material, retention/pooling of material and/or secretion, and entrance of material and/or secretion into the larynx or trachea. A healthcare professional evaluated in the five-point scoring system of each symptom. FEES score = 5 means there were not exhibit disorder, FEES score = 1 means there were abnormalities at severe level | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Premature spillage of material as assessed by a healthcare professional using the FEES | levels of severity of food passed down through the pharynx before swallowing using the five-point scoring system FEES score = 5 means there were not exhibit disorder, FEES score = 1 means there were abnormalities at severe level | Baseline | 
| Retention/pooling of material and/or secretion as assessed by a healthcare professional using the FEES | levels of severity of food or saliva residue in the vallecular and/or pyriform regions of the pharynx after swallowing using the five-point scoring system FEES score = 5 means there were not exhibit disorder, FEES score = 1 means there were abnormalities at severe level | Baseline | 
| Entrance of material and/or secretion into the larynx or trachea; presence/absence of reflex cough as assessed by a healthcare professional using the FEES | levels of severity of food passes through the larynx or trachea when swallowed with or without the cough reflex using the five-point scoring system FEES score = 5 means there were not exhibit disorder, FEES score = 1 means there were abnormalities at severe level | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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swallowing capacity, aging, smoothie drink, dysphagia